Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,583 total recalls
Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney,
Beckman Coulter, Inc.
SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
TEI Biosciences, Inc.
BD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231653¿
Becton Dickinson & Co.
Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
Olympus Corporation of the Americas
RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStatio
RAYSEARCH LABORATORIES AB
iQ 2 Nasal Vented Mask
SleepNet Corporation
REGARD Basic Cataract tray
ROi CPS LLC
RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens:
Rayner Intraocular Lenses Ltd
S4-1 Lumify Transducer Probe
Philips Ultrasound, Inc
NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
Technomed Europe
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: KIT,SUCTION CATH,14FR W/WATER, Mo
MEDLINE INDUSTRIES, LP - Northfield
1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
GE Healthcare, LLC
Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT02086REV3. Kit contents include ULTRAtab L
Total Resources Intl
Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncolo
Philips North America Llc
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
LumiraDx
Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
AVID Medical, Inc.
Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5
Howmedica Osteonics Corp.
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Boston Scientific Corporation
Food Intolerance Test Medium
GET TESTED INTERNATIONAL AB
GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
GE Medical Systems, SCS
MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
Angiodynamics, Inc.
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization
Synthes (USA) Products LLC
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transsepta
Boston Scientific Corporation
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ARTHROSCOPY PACK, Model Number
MEDLINE INDUSTRIES, LP - Northfield
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001845;
Beaver Visitec International, Inc.
www.StradisHealthcare.com, Endovenous Pack, Item No.682-494,
Stradis Medical, LLC dba Stradis Healthcare
S4-2 Transducer Probe
Philips Ultrasound, Inc
MAGNETOM Lumina (DE). Model Number: 11344916.
Siemens Medical Solutions USA, Inc
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
Kamiya Biomedical Company, LLC
Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
Baxter Healthcare Corporation
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