Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,633 total recalls
REGARD Newborn Tray
ROi CPS LLC
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J
Howmedica Osteonics Corp.
ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number
Stryker Corporation
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180065
TELEFLEX LLC
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40
Linkbio Corp.
a. Skin Adhesive McKesson LiquiBand Exceed 0.4 mL Liquid Dome Applicator Tip 2-Octyl Cyanoacrylate. Model Number: 122-LB
Mckesson Medical-Surgical Inc. Corporate Office
RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12
HF Acquisition Co LLC
Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. P
Beaver Visitec International, Inc.
Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg,
Philips North America LLC
Alinity m System, Part Number: 08N53-002
Abbott Molecular, Inc.
Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic
Microcare Medical
Fisher Wallace Stimulator Models FW-100 and FW-200
Fisher Wallace Laboratories Inc.
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urolo
Boston Scientific Corporation
TRACKMASTER, TREADMILL TMX428CP 220V, MODEL NUMBER 317-07929
Full Vision Inc
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780080
TELEFLEX LLC
LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user to easily adjust/control the c
Hill-Rom, Inc.
Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05
AVID Medical, Inc.
One Step pH in vitro diagnostic test REF: 31I4P
DFI Co., Ltd.
Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29
AVID Medical, Inc.
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation Syst
Medtronic Inc
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
Beckman Coulter, Inc.
Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001,
Roche Diabetes Care, Inc.
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
Beckman Coulter Inc.
Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resi
Securitas Healthcare LLC
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001411;
Beaver Visitec International, Inc.
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Luminex Corporation
Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVAS
Cardinal Health 200, LLC
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1
Hamilton Medical AG
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