Medical device recalls and safety notices: last 30 days
New records from 2026-10-05 to 2026-11-04, from our latest imports of public regulator data. Company names are as published by each regulator.
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Leave your company contact detailsHealth Canada recalls (23)
2026-10-27 · Unknown company · Type II
RotaFlow Console
Regulator record2026-10-24 · Roche Diagnostics GmbH · Type II
cobas® c 303 analytical unit
Regulator record2026-10-23 · Unknown company · Type II
Philips Azurion System
Regulator record2026-10-22 · Unknown company · Type II
Vitros Chemistry Products A1c Slides
Regulator record2026-10-22 · Unknown company · Type II
OptiCross Intravascular Ultrasond Imagine Catheters
Regulator record2026-10-21 · Unknown company · Type II
BIOFIRE Blood Culture Identification 2 (BCID2), 30-Pack
Regulator record2026-10-20 · Unknown company · Type II
Siemens Healthcare GmbH Magnetom Systems
Regulator record2026-10-20 · Unknown company · Type II
Siemens Healthineers AG Magnetom and Biograph One Systems
Regulator record2026-10-20 · Unknown company · Type II
Magnetom Free.Max
Regulator record2026-10-20 · Unknown company · Type II
Magnetom Scanner
Regulator record2026-10-16 · Abbott Diabetes Care Ltd. · Type II
FreeStyle Libre 3 App
Regulator record2026-10-15 · Unknown company · Type II
DxC 500i Clinical Analyzer and DxC 500 AU Clinical Chemistry Analyzer
Regulator record2026-10-15 · Midmark Corporation · Type II
IQecg® Digital ECG
Regulator record2026-10-15 · Abbott Point Of Care Inc. · Type II
i-STAT hs-TnI Cartridge
Regulator record2026-10-15 · Unknown company · Type II
PD-L1 IHC 22C3 pharmDx
Regulator record2026-10-14 · Unknown company · Type II
Abre Venous Self-Expanding Stent System
Regulator record2026-10-09 · Keystone Industries · Type II
FP3D™ Resins
Regulator record2026-10-09 · Philips Medical Systems Nederland B.V. · Type II
Philips Allura Xper Systems
Regulator record2026-10-09 · Ge Medical Systems LLC · Type II
SIGNA™ Architect
Regulator record2026-10-08 · Philips Medical Systems Nederland B.V. · Type II
Azurion 7 Systems
Regulator record2026-10-07 · Abbott Laboratories · Type II
ARCHITECT "I" System - i2000SR Processing Module - Class 4
Regulator record2026-10-06 · Nico Corporation · Type II
NICO Myriad™ 19x21.5 MHP Paediscope
Regulator record2026-10-05 · Cochlear Limited · Type II
Cochlear Implant Model CI1012
Regulator record
FDA device recalls (337)
2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195750
Regulator record2026-10-28 · Life Technologies Holdings Pte Ltd · Class II
Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer
Regulator record2026-10-28 · Medline Industries, LP · Class II
MEDLINE medical convenience kits labeled as: 1) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64103C; 2) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64155B.
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105; Material Number: M001195260
Regulator record2026-10-28 · Medtronic Navigation, Inc. · Class II
Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly
Regulator record2026-10-28 · Ventec Life Systems, Inc. · Class I
VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support.
Regulator record2026-10-28 · Greiner Bio-One North America, Inc. · Class II
Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Greiner VACUETTE Blood Collection Tube wit
Regulator record2026-10-28 · Medtronic MiniMed, Inc. · Class II
Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) Software Version: Software version 1.2.1
Regulator record2026-10-28 · TECHNO-PATH MANUFACTURING LTD. · Class II
Techno-Path Multichem AE Unassayed Level 2 REF: AE622X
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130; Material Number: M001195440
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155; Material Number: M001195280
Regulator record2026-10-28 · Ventec Life Systems, Inc. · Class I
VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/130; Material Number: M001195210
Regulator record2026-10-28 · TECHNO-PATH MANUFACTURING LTD. · Class II
Techno-Path Multichem AE Unassayed Level 3, REF:AE623X
Regulator record2026-10-28 · Medtronic Navigation, Inc. · Class II
Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly
Regulator record2026-10-28 · Ventec Life Systems, Inc. · Class I
V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000. used for ventilatory support.
Regulator record2026-10-28 · Medline Industries, LP · Class II
MEDLINE medical convenience kits labeled as (list truncated)
Regulator record2026-10-28 · Beckman Coulter, Inc. · Class II
ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima X
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130; Material Number: M001195840
Regulator record2026-10-28 · Medtronic Neuromodulation · Class II
InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030
Regulator record2026-10-28 · Medtronic Navigation, Inc. · Class II
Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130; Material Number: M001195240
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130; Material Number: M001195340
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/STRAIGHT/1RO/130; Material Number: M001195810
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130; Material Number: M001195300
Regulator record2026-10-28 · Medline Industries, LP · Class II
MEDLINE medical convenience kits labeled as: (list truncated)
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/105; Material Number: M001195230
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/155; Material Number: M001195450
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/STRAIGHT/1RO/130; Material Number: M001195910
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/BERN/1RO/130; Material Number: M001195940
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/155; Material Number: M001195350
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/155; Material Number: M001195420
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/105; Material Number: M001195200
Regulator record2026-10-28 · Medtronic MiniMed, Inc. · Class II
CareLink Clinic, REF: MMT-7350
Regulator record2026-10-28 · Ventec Life Systems, Inc. · Class I
VCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support.
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/155; Material Number: M001195220
Regulator record2026-10-28 · Medline Industries, LP · Class II
MEDLINE medical convenience kits labeled as: 1) LAPAROTOMY GYN CDS, Medline Kit Number/SKU CDS983529O; 2) GYN ROBOTIC PK-LF, Medline Kit Number/SKU DYNJ524
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/130; Material Number: M001195410
Regulator record2026-10-28 · Think Surgical, Inc. · Class II
Think Surgical Square Driver REF: 109126
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130; Material Number: M001195500
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/155; Material Number: M001195310
Regulator record2026-10-28 · B Braun Medical Inc · Class II
B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/155; Material Number: M001195250
Regulator record2026-10-28 · Axonics, Inc. · Class II
PNE Lead Implant Kit REF: 1701
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/130; Material Number: M001195740
Regulator record2026-10-28 · Medline Industries, LP · Class II
MEDLINE medical convenience kits labeled as: FETOSCOPY CDS-LF, Medline Product Number/SKU CDS840215P
Regulator record2026-10-28 · Philips North America · Class II
Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;
Regulator record2026-10-28 · Ventec Life Systems, Inc. · Class I
VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.
Regulator record2026-10-28 · AVID Medical, Inc. · Class II
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/155; Material Number: M001195720
Regulator record2026-10-28 · Medline Industries, LP · Class II
MEDLINE medical convenience kits labeled as: C-SECTION TRAY-LF, Medline Kit Number/SKU OBN471K
Regulator record2026-10-28 · Ventec Life Systems, Inc. · Class I
VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support.
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/105; Material Number: M001195400
Regulator record2026-10-28 · Medtronic Navigation, Inc. · Class II
Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly
Regulator record2026-10-28 · Ventec Life Systems, Inc. · Class I
VC+Pro (Japan) Model Number: PRT-00900-100, Package PN:PRT-00973-100. used for ventilatory support.
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/155; Material Number: M001195620
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130; Material Number: M001195610
Regulator record2026-10-28 · Philips Ultrasound, LLC · Class I
Philips Lumify Diagnostic Ultrasound System
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130; Material Number: M001195670
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/2RO/130; Material Number: M001195660
Regulator record2026-10-28 · Ventec Life Systems, Inc. · Class I
VC Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support.
Regulator record2026-10-28 · TECHNO-PATH MANUFACTURING LTD. · Class II
Techno-Path Multichem AE Unassayed Level 1 REF:AE621X
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/130; Material Number: M001195470
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/155; Material Number: M001195510
Regulator record2026-10-28 · Medline Industries, LP · Class II
MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE, Medline Product Number/SKU DYNJP6106
Regulator record2026-10-28 · Abbott · Class II
Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2. 9-ACP2-007-018 3. 9-ACP2-007-020 4. 9-ACP2-007-022 5. 9-ACP2-010-025
Regulator record2026-10-28 · Beckman Coulter, Inc. · Class II
ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima X
Regulator record2026-10-28 · AVID Medical, Inc. · Class II
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31.
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/105; Material Number: M001195430
Regulator record2026-10-28 · Medline Industries, LP · Class II
MEDLINE medical convenience kits labeled as: TUBAL LIGATION RFD, Medline Product Number/SKU DYNJ906291G
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/130; Material Number: M001195640
Regulator record2026-10-28 · Medline Industries, LP · Class II
MEDLINE medical convenience kits labeled as: C-SECTION PACK, Medline Product Number/SKU DYNJ48455A
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/155; Material Number: M001195480
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/155; Material Number: M001195850
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/155; Material Number: M001195650
Regulator record2026-10-28 · Medline Industries, LP · Class II
MEDLINE DRAPE C-SECTION FEN CLR SCREEN W, Medline Product Number/SKU DYNJP6108
Regulator record2026-10-28 · CooperVision, Inc. · Class II
Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number: Softmed Breathables Advanced Toric Produ
Regulator record2026-10-28 · restor3d Inc. · Class II
Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software Version: None Product Description: The restor3d Meta
Regulator record2026-10-28 · Medline Industries, LP · Class II
MEDLINE medical convenience kits labeled as: 1) FETAL SURGERY CDS-LF, Medline Kit Number/SKUCDS840214R; 2) MAJOR, Medline Kit Number/SKUDYNJ904851I; 3) ABD
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/130; Material Number: M001195270
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/130; Material Number: M001195320
Regulator record2026-10-28 · Solstice Corporation · Class II
Xact mole marker for mammography Model/Catalog Number: M15RM
Regulator record2026-10-28 · Medtronic Neuromodulation · Class II
InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI TINED 978A128 LEAD 978A133 ISTM MICRO 33CM SSMRI TINED 978A133 LEAD 97
Regulator record2026-10-28 · Ventec Life Systems, Inc. · Class I
V+Pro Model Number: PRT-01185-000, Package PN:PRT-01198-000; Model Number: PRT-01185-001, Package PN: N/A; Model Number: PRT-01185-002, Package PN:N/A. used f
Regulator record2026-10-28 · Ventec Life Systems, Inc. · Class I
V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support.
Regulator record2026-10-28 · Medline Industries, LP · Class II
MEDLINE medical convenience kits labeled as: 1) BIRTHDAY KIT-DOUBLE BASIN-LF, Medline Kit Number/SKU DYNJ16127N; 2) NYGH-DELIVERY PACK-LF, Medline Kit Numb
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/155; Material Number: M001195330
Regulator record2026-10-28 · Ventec Life Systems, Inc. · Class I
VC+Pro Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory support.
Regulator record2026-10-28 · Medline Industries, LP · Class II
MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101
Regulator record2026-10-28 · Ventec Life Systems, Inc. · Class I
VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support.
Regulator record2026-10-28 · Boston Scientific Cork, Ltd. · Class II
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/130; Material Number: M001195710
Regulator record2026-10-21 · Medline Industries, LP · Class II
Medline surgical convenience kits labeled as: 1) EAR, Medline product number/SKU DYNJ909020B; 2) EAR, Medline product number/SKU DYNJ909020A; 3) CAROTID
Regulator record2026-10-21 · Medline Industries, LP · Class II
Medline surgical convenience kits labeled as: VEIN HARVESTING PACK, Medline product number/SKU DYNJ51845D
Regulator record2026-10-21 · Howmedica Osteonics Corp. · Class II
Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
Regulator record2026-10-21 · Medline Industries, LP · Class II
Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135A CHN GYN ONCOLOGY DYNJ906731M
Regulator record2026-10-21 · Medline Industries, LP · Class II
Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D
Regulator record2026-10-21 · Magellan Diagnostics, Inc. · Class III
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
Regulator record2026-10-21 · Beckman Coulter, Inc. · Class II
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
Regulator record2026-10-21 · Medline Industries, LP · Class II
Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A; 2) AV SHUNT PACK-LF, Medline Product Number
Regulator record2026-10-21 · SI-BONE, Inc. · Class II
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
Regulator record2026-10-21 · Becton Dickinson & Co. · Class II
BD Phoenix Panel NMIC-306. Catalog Number: 449292.
Regulator record2026-10-21 · Ethicon, LLC · Class II
PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
Regulator record2026-10-21 · Howmedica Osteonics Corp. · Class II
TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
Regulator record2026-10-21 · Ferno-Washington Inc · Class II
Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2 Premium, Item No. 0015821
Regulator record2026-10-21 · Medline Industries, LP · Class II
Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY PACK, Medline Product
Regulator record2026-10-21 · Instrumentation Laboratory · Class I
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Regulator record2026-10-21 · Cook Incorporated · Class II
Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Order
Regulator record2026-10-21 · Medtronic Sofamor Danek USA Inc · Class II
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft
Regulator record2026-10-21 · Medline Industries, LP · Class II
Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A
Regulator record2026-10-21 · Baxter Healthcare Corporation · Class II
Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product Description: LIKORALL 242 ES, NATURAL P
Regulator record2026-10-21 · Medline Industries, LP · Class II
Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY DYNJ906731K DYNJ906731L DYNJ906731N DAVINCI PROSTATECTOMY DYNJG
Regulator record2026-10-21 · Medline Industries, LP · Class II
Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline product number/SKU CDS840094R; 2) OPEN HEART CDS, Medline product number/SKU CDS84
Regulator record2026-10-21 · Medline Industries, LP · Class II
Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC; 2) MAIN/LAPAROSCOPY TRANSPLA PAC
Regulator record2026-10-21 · Medtronic Sofamor Danek USA Inc · Class II
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograf
Regulator record2026-10-21 · BioFire Diagnostics, LLC · Class II
Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135
Regulator record2026-10-21 · Instrumentation Laboratory · Class I
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
Regulator record2026-10-21 · INTELERAD MEDICAL SYSTEMS INCORPORATED · Class II
IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50
Regulator record2026-10-21 · Howmedica Osteonics Corp. · Class II
TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507.
Regulator record2026-10-21 · Medline Industries, LP · Class II
Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K; 2) CV BASIN PACK-LF, Medline product number/SK
Regulator record2026-10-21 · Medline Industries, LP · Class II
Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G
Regulator record2026-10-21 · Radiometer Medical ApS · Class II
The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a labor
Regulator record2026-10-21 · Cadwell Industries Inc · Class II
Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The IOMAX Cortical M
Regulator record2026-10-21 · In2bones USA, LLC · Class II
REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
Regulator record2026-10-21 · Medline Industries, LP · Class II
Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product Number/SKU CDS940087AM; 2) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697
Regulator record2026-10-21 · Beckman Coulter, Inc. · Class II
IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684; IQ200 ELITE, REF: 700-33
Regulator record2026-10-21 · Jenavalve Technology Inc. · Class II
JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
Regulator record2026-10-21 · Steris Corporation · Class II
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
Regulator record2026-10-21 · Microgenics Corporation · Class II
MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Contr
Regulator record2026-10-21 · W L Gore & Associates, Inc. · Class II
Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire Bil
Regulator record2026-10-21 · Jenavalve Technology Inc. · Class II
JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
Regulator record2026-10-21 · Medline Industries, LP · Class II
Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732J; 2) NBMC VASCULAR PACK-LF, Medline produc
Regulator record2026-10-21 · Steris Corporation · Class II
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117
Regulator record2026-10-21 · INTEGRATED MEDCRAFT LLC · Class II
FORWARD Gunshot Wound Kit; Model: AFT-GSW;
Regulator record2026-10-21 · BioFire Diagnostics, LLC · Class II
Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit)
Regulator record2026-10-21 · Medline Industries, LP · Class II
1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528N; 3) Produc
Regulator record2026-10-21 · Medline Industries, LP · Class II
Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071 ROBOTIC PACK DYNJ50474F
Regulator record2026-10-21 · Sarnova HC, Llc · Class II
Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KIT
Regulator record2026-10-21 · Medline Industries, LP · Class II
Convenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258 KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I ROBO
Regulator record2026-10-21 · Becton Dickinson & Co. · Class II
BD Phoenix Panel NMIC-312. Catalog Number: 449082.
Regulator record2026-10-21 · Healthmark Industries Co., Inc. · Class II
Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD 1/16 X 3/4, Model N
Regulator record2026-10-21 · Merit Medical Systems, Inc. · Class II
Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, St
Regulator record2026-10-21 · Medline Industries, LP · Class II
Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D
Regulator record2026-10-21 · Medline Industries, LP · Class II
Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135 LAP CHOLE DYNJ911660 LAP NISSEN DYNJ911560 UROLOG
Regulator record2026-10-21 · Jenavalve Technology Inc. · Class II
JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S
Regulator record2026-10-21 · Howmedica Osteonics Corp. · Class II
TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.
Regulator record2026-10-21 · BioFire Diagnostics, LLC · Class II
Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-
Regulator record2026-10-21 · Boston Scientific Corporation · Class II
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Regulator record2026-10-21 · Neuronetics, Inc. · Class II
NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems: 1.
Regulator record2026-10-21 · Steris Corporation · Class II
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
Regulator record2026-10-14 · Canon Medical System, USA, INC. · Class II
Alphenix INFX-8000C/B5
Regulator record2026-10-14 · DRG International, Inc. · Class II
Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Regulator record2026-10-14 · Medline Industries, LP · Class II
Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support whil
Regulator record2026-10-14 · Safeguard US Operating LLC · Class II
Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag, Multicam - Advanced, REF: 81-125-MC; Patrol IFAK II, Olive D
Regulator record2026-10-14 · Steris Corporation · Class II
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
Regulator record2026-10-14 · Steris Corporation · Class II
VERIFY Biological Steam Test Pack Model/Catalog Number: S3069
Regulator record2026-10-14 · AVID Medical, Inc. · Class II
MAJOR PACK; Model/Item Number (Kit): NIHB0018-11;
Regulator record2026-10-14 · AVID Medical, Inc. · Class II
GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03;
Regulator record2026-10-14 · Mindray DS USA, Inc. · Class III
BeneView Series. Operator's Manuals: T5 / T8
Regulator record2026-10-14 · Intellijoint Surgical, Inc. · Class II
Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 0
Regulator record2026-10-14 · Medtronic MiniMed, Inc. · Class II
Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an alte
Regulator record2026-10-14 · Mindray DS USA, Inc. · Class III
T1 Patient Monitor. Operator's Manual: T1 Patient Monitor
Regulator record2026-10-14 · PHILIPS MEDICAL SYSTEMS · Class II
Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (U.S. and Outside U.
Regulator record2026-10-14 · Onkos Surgical, Inc. · Class II
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Regulator record2026-10-14 · Nihon Kohden America LLC · Class II
Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03, 01-04, 01-05, 01-0
Regulator record2026-10-14 · Steris Corporation · Class II
VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006
Regulator record2026-10-14 · Limitless Cryo Spa LLC · Class II
Glypto Device, Glypto Cryo Machine;
Regulator record2026-10-14 · Steris Corporation · Class II
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060
Regulator record2026-10-14 · AVID Medical, Inc. · Class II
ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;
Regulator record2026-10-14 · Steris Corporation · Class II
VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007
Regulator record2026-10-14 · AVID Medical, Inc. · Class II
ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08;
Regulator record2026-10-14 · Onkos Surgical, Inc. · Class II
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Regulator record2026-10-14 · AVID Medical, Inc. · Class II
CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20;
Regulator record2026-10-14 · Steris Corporation · Class II
HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control,
Regulator record2026-10-14 · Mindray DS USA, Inc. · Class III
ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Regulator record2026-10-14 · AVID Medical, Inc. · Class II
DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;
Regulator record2026-10-14 · AVID Medical, Inc. · Class II
PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07;
Regulator record2026-10-14 · Medline Industries, LP · Class II
Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support
Regulator record2026-10-14 · AVID Medical, Inc. · Class II
GYN LAPAROSCOPY PACK; Model/Item Number (Kit): NAMC436-12;
Regulator record2026-10-14 · AVID Medical, Inc. · Class II
ABD HYSTERECTOMY; Model/Item Number (Kit): NAMC438-07;
Regulator record2026-10-14 · Mindray DS USA, Inc. · Class III
BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
Regulator record2026-10-14 · Stryker Sustainability Solutions · Class II
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Regulator record2026-10-14 · Steris Corporation · Class II
VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
Regulator record2026-10-14 · Medical Action Industries, Inc. 306 · Class III
Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number: 333606 UDI-DI: 20809160118228 Soft
Regulator record2026-10-14 · Mindray DS USA, Inc. · Class III
Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).
Regulator record2026-10-14 · Cardinal Health 200, LLC · Class II
Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Intubating B
Regulator record2026-10-14 · Beckman Coulter Inc. · Class II
DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 M
Regulator record2026-10-14 · POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC · Class II
SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;
Regulator record2026-10-14 · AVID Medical, Inc. · Class II
DAVINCI LAP/GYN; Model/Item Number (Kit): WRNM037-16;
Regulator record2026-10-14 · Mindray DS USA, Inc. · Class III
BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
Regulator record2026-10-14 · AVID Medical, Inc. · Class II
ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04;
Regulator record2026-10-14 · GRI Medical & Electronic Technology Co., Ltd. · Class II
HALYARD Laparoscopy Comprehensive Pack II REF: 49332
Regulator record2026-10-14 · Beckman Coulter Inc. · Class II
DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
Regulator record2026-10-14 · Mindray DS USA, Inc. · Class III
cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
Regulator record2026-10-14 · AVID Medical, Inc. · Class II
LAPAROSCOPIC PROSTATECTOMY; Model/Item Number (Kit): NIHB0036-07;
Regulator record2026-10-14 · QUANTUM OPS Inc · Class II
Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number: 804-33-300 (Enovis); 3105-400-030 (Stryker); i
Regulator record2026-10-14 · LeMaitre Vascular, Inc. · Class II
TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Regulator record2026-10-14 · AVID Medical, Inc. · Class II
HEART PREP TRAY; Model/Item Number (Kit): MECV97W;
Regulator record2026-10-14 · Mindray DS USA, Inc. · Class III
Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
Regulator record2026-10-14 · AVID Medical, Inc. · Class II
PLASTICS TRAY; Model/Item Number (Kit): EURO053;
Regulator record2026-10-14 · AVID Medical, Inc. · Class II
UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10;
Regulator record2026-10-07 · Philips North America · Class II
Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;
Regulator record2026-10-07 · Philips North America · Class II
Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 (S), 5. 782194 (S), 6. 781356 (X), 7. 78
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 1 LINE (10) Model/Catalog Number: DT-7030-01Q Software Version: Not Applicable Product Descripti
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-LINE (CS 10) YELLOW Model/Catalog Number: 564009 Software Version: Not Applicabl
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-LINE (CS 12) PLUM Model/Catalog Number: A70107003 Software Version: Not Applic
Regulator record2026-10-07 · Volcano Corp · Class II
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Regulator record2026-10-07 · Philips North America · Class II
Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software Versions: R11, R12 and R13;
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 26" X 6" DUAL BLADDER, 2-LINE (CS 12) ORANGE Model/Catalog Number: A70107017 Software Ve
Regulator record2026-10-07 · Cardinal Health 200, LLC · Class II
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2) KIT, GYN LAPAROSCOPY N
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 18) RED Model/Catalog Number: A70107007 Software Version: Not Applicable
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 18) WHITE Model/Catalog Number: 553322 Software Version: Not Applicable
Regulator record2026-10-07 · American Contract Systems Inc · Class II
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Model No. MHAH55AM L
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 18) YELLOW Model/Catalog Number: A70107008 Software Version: Not Applica
Regulator record2026-10-07 · American Nitrile Operations Llc · Class II
Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Description: Blue Nitril
Regulator record2026-10-07 · Penumbra Inc. · Class II
Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT So
Regulator record2026-10-07 · Shanghai United Imaging Healthcare Co., Ltd. · Class II
Computed Tomography X-ray System, Model: uCT 550 with software
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-Line, Blue Model/Catalog Number: ASP-564012 Software Version: Not Applicable Pr
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 10) RED Model/Catalog Number: 564007 Software Version: Not Applicable
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 18) WHITE Model/Catalog Number: 553323 Software Version: Not Applicable
Regulator record2026-10-07 · Medline Industries, LP · Class I
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITE
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 2-LINE (CS 12) LIGHT BLUE Model/Catalog Number: A70107001 Software Version: Not A
Regulator record2026-10-07 · SPECTRUM MEDICAL SRL · Class II
Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog Number: HX55V-S0W Software Version: N/A Pr
Regulator record2026-10-07 · Merit Medical Systems, Inc. · Class II
Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820G
Regulator record2026-10-07 · Shanghai United Imaging Healthcare Co., Ltd. · Class II
Computed Tomography X-ray System, Model: uCT 530 with software
Regulator record2026-10-07 · Percussionaire Corporation · Class II
Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 2 LINE (10) Model/Catalog Number: DT-7044-02Q Software Version: Not Applicable Product Descripti
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-Line, Yellow Model/Catalog Number: ASP-564009 Software Version: Not Applicable Pr
Regulator record2026-10-07 · Philips North America · Class II
MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 2 LINE (10) Model/Catalog Number: DT-7024-02Q Software Version: Not Applicable Product Descripti
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 20" X 6" 1-LINE (CS 10) NAVY BLUE Model/Catalog Number: 564017 Software Version: Not Applic
Regulator record2026-10-07 · SPECTRUM MEDICAL SRL · Class II
Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 Model/Catalog Number: HX55W-S0 Software Version: N/A Produ
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 10) WHITE Model/Catalog Number: 564010 Software Version: Not Applicable
Regulator record2026-10-07 · Karl Storz Endoscopy · Class II
HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are to be used for visualization of the su
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-Line, Plum Model/Catalog Number: ASP-564003 Software Version: Not Applicable Pr
Regulator record2026-10-07 · Custom Interventional Pain Management, LLC · Class II
Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM Product Name: Mastisol Skin Adhesive Model/Catalog Number: 24161B (Fern
Regulator record2026-10-07 · Percussionaire Corporation · Class II
Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
Regulator record2026-10-07 · Medline Industries, LP · Class I
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/ MDR107002E MDR520094 PENDANT F/ MDR107003E MDR5
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 20" X 6" DUAL BLADDER 1-LINE (CS 12) NAVY BLUE Model/Catalog Number: A70107014 Software Ve
Regulator record2026-10-07 · Philips North America · Class II
Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 (1.5T), 5. 782140 (1.5T), 6. 781262 (1.
Regulator record2026-10-07 · Shanghai United Imaging Healthcare Co., Ltd. · Class II
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
Regulator record2026-10-07 · Philips North America · Class II
Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1.5T), 4. 782201(1.5T), 5. 782117 (3.0T),
Regulator record2026-10-07 · Cardinal Health 200, LLC · Class II
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU; 2) KIT,GU DAVINCI
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 38" X 4" 1-LINE (CS 10) Model/Catalog Number: 564044 Software Version: Not Applicable Prod
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-Line, Red Model/Catalog Number: ASP-564007 Software Version: Not Applicable Produ
Regulator record2026-10-07 · Philips North America Llc · Class II
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-LINE (CS 12) GREEN Model/Catalog Number: A70107012 Software Version: Not Applicab
Regulator record2026-10-07 · Shanghai United Imaging Healthcare Co., Ltd. · Class II
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software
Regulator record2026-10-07 · Shanghai United Imaging Healthcare Co., Ltd. · Class II
Computed Tomography X-ray System, Model: uCT 780 with software
Regulator record2026-10-07 · Shanghai United Imaging Healthcare Co., Ltd. · Class II
Computed Tomography X-ray System, Model: uCT ATLAS with software
Regulator record2026-10-07 · Alere San Diego, Inc. · Class II
Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025;
Regulator record2026-10-07 · Draeger, Inc. · Class I
VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 26" DUAL BLADDER, 2 LINE (10) Model/Catalog Number: DB-7024-02Q Software Version: Not Applicable Pro
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-LINE (CS 18) RED Model/Catalog Number: A70107006 Software Version: Not Applicable
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 18" 1 LINE (10) Model/Catalog Number: DT-7018-01Q Software Version: Not Applicable Product Descripti
Regulator record2026-10-07 · Percussionaire Corporation · Class II
In-Line Valve, Product Number: P5-TEE
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 26" X 6" DUAL BLADDER, 1-LINE (CS 12) ORANGE Model/Catalog Number: A70107016 Software Vers
Regulator record2026-10-07 · Illumina, Inc. · Class II
NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-Line, White Model/Catalog Number: ASP-564010 Software Version: Not Applicable Pro
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2-LINE (CS 12) GRAY Model/Catalog Number: A70107005 Software Version: Not Applicabl
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 1 LINE (10) Model/Catalog Number: DT-7112-01Q Software Version: Not Applicable Product Descripti
Regulator record2026-10-07 · Percussionaire Corporation · Class II
Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual
Regulator record2026-10-07 · Olympus Corporation of the Americas · Class II
Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
Regulator record2026-10-07 · Micro Therapeutics, Inc. · Class II
Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization Device with Shield Techno
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 2 LINE (10) Model/Catalog Number: DB-7020-02Q Software Version: Not Applicable Pro
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-LINE (CS 10) GREEN Model/Catalog Number: 564015 Software Version: Not Applicable
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 1 LINE (10) Model/Catalog Number: DT-7034-01Q Software Version: Not Applicable Product Descripti
Regulator record2026-10-07 · Bard Peripheral Vascular Inc · Class II
EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 1 LINE (10) Model/Catalog Number: DB-7018-01Q Software Version: Not Applicable Pro
Regulator record2026-10-07 · American Contract Systems Inc · Class II
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays CARDIAC HEART BUNDLE NS Model No. LMCH99P OPEN HEART
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 1 LINE (10) Model/Catalog Number: DT-7024-01Q Software Version: Not Applicable Product Descripti
Regulator record2026-10-07 · Philips North America · Class II
MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;
Regulator record2026-10-07 · Philips North America · Class II
SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;
Regulator record2026-10-07 · Alere San Diego, Inc. · Class II
Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074, FHC-102/9
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 10) BLUE Model/Catalog Number: 564013 Software Version: Not Applicable
Regulator record2026-10-07 · Heraeus Medical GmbH (Dental Division) · Class II
PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled
Regulator record2026-10-07 · Shanghai United Imaging Healthcare Co., Ltd. · Class II
Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2-LINE (CS 10) GRAY Model/Catalog Number: 564005 Software Version: Not Applicable
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 15" X 4" 1-LINE (CS 12) GRAY Model/Catalog Number: A70107004 Software Version: Not Applicab
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-LINE (CS 10) PLUM Model/Catalog Number: 564003 Software Version: Not Applicabl
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 1-LINE (CS 12) LIGHT BLUE Model/Catalog Number: A70107000 Software Version: Not A
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-Line, Red Model/Catalog Number: ASP-564006 Software Version: Not Applicable Produ
Regulator record2026-10-07 · Cardinal Health 200, LLC · Class II
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-Line, White Model/Catalog Number: ASP-564011 Software Version: Not Applicable Pro
Regulator record2026-10-07 · Shanghai United Imaging Healthcare Co., Ltd. · Class II
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software
Regulator record2026-10-07 · Wright Medical Technology, Inc. · Class II
CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 2 LINE (10) Model/Catalog Number: DT-7115-02Q Software Version: Not Applicable Product Descrip
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 1 LINE (10) Model/Catalog Number: DT-7044-01Q Software Version: Not Applicable Product Descripti
Regulator record2026-10-07 · Olympus Corporation of the Americas · Class II
Olympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an accessory used in conjunction wtih OLYSENSE Hub System
Regulator record2026-10-07 · Shanghai United Imaging Healthcare Co., Ltd. · Class II
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software
Regulator record2026-10-07 · Shanghai United Imaging Healthcare Co., Ltd. · Class II
Computed Tomography X-ray System, Model: uCT 760 with software
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 2-LINE (CS 10) Model/Catalog Number: 564001 Software Version: Not Applicable Pro
Regulator record2026-10-07 · Philips North America · Class II
Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 782137 (S), 4. 782157 (S), 5. 781358 (X), 6. 782107 (X), 7. 7821
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 2 LINE (10) Model/Catalog Number: DT-7030-02Q Software Version: Not Applicable Product Descripti
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-LINE (CS 10) BLUE Model/Catalog Number: 564012 Software Version: Not Applicable
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 10) WHITE Model/Catalog Number: 564011 Software Version: Not Applicable
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 26" X 6" 1-LINE (CS 10) ORANGE Model/Catalog Number: 564019 Software Version: Not Applicabl
Regulator record2026-10-07 · Olympus Corporation of the Americas · Class II
Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
Regulator record2026-10-07 · American Nitrile Operations Llc · Class II
Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904 Product Description: Blue
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 2 LINE (10) Model/Catalog Number: DT-7112-02Q Software Version: Not Applicable Product Descripti
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-Line, Blue Model/Catalog Number: ASP-564013 Software Version: Not Applicable Prod
Regulator record2026-10-07 · Beckman Coulter Mishima K.K. · Class II
Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B96693 / 14987666542972
Regulator record2026-10-07 · Percussionaire Corporation · Class II
Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual
Regulator record2026-10-07 · Alere San Diego, Inc. · Class II
McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210; Fisher Scientific Sure-
Regulator record2026-10-07 · Cardinal Health 200, LLC · Class II
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 10) YELLOW Model/Catalog Number: 564008 Software Version: Not Applicabl
Regulator record2026-10-07 · Tandem Diabetes Care, Inc. · Class II
Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS
Regulator record2026-10-07 · American Contract Systems Inc · Class II
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AO
Regulator record2026-10-07 · Heraeus Medical GmbH (Dental Division) · Class II
PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled int
Regulator record2026-10-07 · Heraeus Medical GmbH (Dental Division) · Class II
PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled i
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 8" 2 LINE (10) Model/Catalog Number: DT-7108-02Q Software Version: Not Applicable Product Descriptio
Regulator record2026-10-07 · Shanghai United Imaging Healthcare Co., Ltd. · Class II
Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software
Regulator record2026-10-07 · Philips North America · Class II
Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;
Regulator record2026-10-07 · HeartSine Technologies Ltd · Class III
HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US De
Regulator record2026-10-07 · Siemens Healthcare Diagnostics, Inc. · Class II
Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
Regulator record2026-10-07 · American Nitrile Operations Llc · Class II
Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800, 72-50801,72-50802,72-50803,72-50804 Product Description: Blue Nitri
Regulator record2026-10-07 · Percussionaire Corporation · Class II
Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 18) BLUE Model/Catalog Number: A70107011 Software Version: Not Applicabl
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-LINE (CS 10) RED Model/Catalog Number: 564006 Software Version: Not Applicable
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 18" 2 LINE (10) Model/Catalog Number: DT-7218-02Q Software Version: Not Applicable Product Descrip
Regulator record2026-10-07 · Philips North America · Class II
Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-Line, Green Model/Catalog Number: ASP-564014 Software Version: Not Applicable Pro
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 2 LINE (10) Model/Catalog Number: DT-7034-02Q Software Version: Not Applicable Product Descripti
Regulator record2026-10-07 · Shanghai United Imaging Healthcare Co., Ltd. · Class II
Positron Emission Tomography and Computed Tomography System, Model: uMI 780
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-LINE (CS 18) YELLOW Model/Catalog Number: A70107009 Software Version: Not Applica
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-LINE (CS 18) BLUE Model/Catalog Number: A70107010 Software Version: Not Applicabl
Regulator record2026-10-07 · Alere San Diego, Inc. · Class II
Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Part:FHC-101/5000; Hen
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-LINE (CS 12) GREEN Model/Catalog Number: A70107013 Software Version: Not Applicab
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-Line, Green Model/Catalog Number: ASP-564015 Software Version: Not Applicable P
Regulator record2026-10-07 · Percussionaire Corporation · Class II
Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with In
Regulator record2026-10-07 · Heraeus Medical GmbH (Dental Division) · Class II
PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cement, pre-filled into
Regulator record2026-10-07 · NOXBOX LTD · Class II
NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 1-LINE (CS 12) PLUM Model/Catalog Number: A70107002 Software Version: Not Applic
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 1 LINE (10) Model/Catalog Number: DT-7115-01Q Software Version: Not Applicable Product Descripti
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-Line, Yellow Model/Catalog Number: ASP-564008 Software Version: Not Applicable Pr
Regulator record2026-10-07 · Philips North America · Class II
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and SmartPath to Ingenia Elition X; Model number (REF): 1.
Regulator record2026-10-07 · ASP Global, LLC. · Class II
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-LINE (CS 10) GREEN Model/Catalog Number: 564014 Software Version: Not Applicable
Regulator record
FDA warning letters (7)
2026-11-03 · Next Medical Products Company, LLC
CGMP/QSR/Medical Devices/Adulterated
Regulator record2026-10-27 · Pro-Optics, LLC
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Regulator record2026-10-27 · Chirp Innovations, LLC
CGMP/QSR/Medical Devices/Adulterated
Regulator record2026-10-27 · Peter Schiff Enterprises
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
Regulator record2026-10-20 · Olympus Medical Systems Corporation
CGMP/QSR/Medical Devices/Adulterated
Regulator record2026-10-06 · O.N. Diagnostics, LLC
Medical Device Reporting/Misbranded
Regulator record2026-10-06 · Unilam Co., LTD
CGMP/QSR/Medical Devices/Adulterated
Regulator record
UK MHRA safety alerts and notices (6)
2026-10-27 · MHRA · field-safety-notices
Field Safety Notices: 19 to 23 October 2026
Regulator record2026-10-13 · MHRA · device-safety-information
Continuous renal replacement therapy (CRRT): Consider delayed administration of concurrent echinocandins, such as caspofungin, to reduce the risk of adsorption onto new polyacrylonitrile (PAN)-based filter membranes DSI/2026/014
Regulator record2026-10-13 · MHRA · field-safety-notices
Field Safety Notices: 5 to 9 October 2026
Regulator record2026-10-12 · MHRA · field-safety-notices
Field Safety Notices: 12 to 16 October 2026
Regulator record2026-10-09 · MHRA · device-safety-information
Nova Biomedical StatStrip ketone test strips: risk of disruption to blood ketone testing due to quality-control failures and supply interruption DSI/2026/013
Regulator record2026-10-09 · MHRA · field-safety-notices
Field Safety Notices for October 2026
Regulator record