Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,606 total recalls
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H749085261712; cardiac catheter
Boston Scientific Corporation
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
GE Medical Systems, LLC
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of
Atrium Medical Corporation
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
DeRoyal Industries Inc
Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER TRACH CDS , Pack Number CD
MEDLINE INDUSTRIES, LP - Northfield
Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
MEDLINE INDUSTRIES, LP - Northfield
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
Baxter Healthcare Corporation
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 Con
Philips North America Llc
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC
MEDLINE INDUSTRIES, LP - Northfield
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac catheter
Boston Scientific Corporation
Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;
Telcare, LLC
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa
B Braun Medical Inc
VITEK 2 AST-N447 TEST KIT Product reference 424620
Biomerieux Inc
WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures caused
Boston Scientific Corporation
Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered infusion pump for intravenous (IV) administra
B. Braun Medical, Inc.
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Number: CDS840150W; 3)
Medline Industries, LP
MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
MEDLINE INDUSTRIES, LP - Northfield
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100
Baxter Healthcare Corporation
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, power
SURGIFY MEDICAL OY
Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J;
American Contract Systems, Inc.
Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l XX Serie
Defibtech, LLC
Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
Roche Diabetes Care, Inc.
PIVO Blood Collection Device 20G, REF: 202-0005
Velano Vascular
DYNEX Agility, Agility Analyzer, Model No. 67000
Dynex Technologies, Inc.
STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray
Stradis Medical, LLC dba Stradis Healthcare
MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
Canadian Hospital Specialties
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,
Vyaire Medical
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181030
TELEFLEX LLC
DeRoyal SHOULDER ARTHORSCOPY PACK RF, REF 89-6628.09
DeRoyal Industries Inc
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