RecallHawk

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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