Medical Device Recalls

VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS

Stradis Healthcare

Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG,

Defibtech, LLC

BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-p

CAREFUSION

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Numbe

Dexcom, Inc.

Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system

Luminex Corporation

PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general so

Ethicon, LLC

GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08

American Contract Systems Inc

Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Nu

Integra LifeSciences Corp.

MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1

Medtronic MiniMed, Inc.

IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x

Alphatec Spine, Inc.

Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl tran

Siemens Healthcare Diagnostics, Inc.

CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNTURN Catalog # CKF105L

Mckesson Medical-Surgical Inc. Corporate Office

Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 34

Encore Medical, LP

Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical

Deerfield Imaging, Inc.

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

Thoratec Corp.

Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in sampl

Beckman Coulter Mishima K.K.

smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714

Smiths Medical ASD, Inc.

(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients wit

Fresenius Medical Care Holdings, Inc.

DERMLITE DL4W, REF: DL4W, Rx Only MD, CE

DermLite LLC

Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media

Olympus Corporation of the Americas

DR 800. Digital Radiography X-ray System.

Agfa N.V.

HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; A

I.T.S. GmbH

GS0008 2Y - Burn Pack - STL, Item Number 880082025

ROi CPS LLC

Monoject 20 mL Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC

Soft Tissue Biopsy Needles

M.D.L. S.r.l.

Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS

ARROW INTERNATIONAL Inc.

Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Corti

I.T.S. GmbH

epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

Siemens Healthcare Diagnostics Inc

Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM

Bard Peripheral Vascular Inc