Medical Device Recalls

Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47

Exactech, Inc.

CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.

Maquet Medical Systems USA

Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces betwe

Beckman Coulter Inc.

Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840

INSPIREMD Inc

Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-M Product Description: NON-Sterile sy

Jiangsu Shenli Medical Production Co., Ltd.

Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's In

B Braun Medical Inc

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001113;

Beaver Visitec International, Inc.

Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introduce

Cook Inc.

Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena

Randox Laboratories Ltd.

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)

Johnson & Johnson Surgical Vision, Inc.

ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

SIGNA Premier systems

GE Healthcare LLC

COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjun

Beckman Coulter, Inc.

LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting

Waldemar Link GmbH & Co. KG (Mfg Site)

epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1

Siemens Healthcare Diagnostics Inc

GE Signa Artist, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instr

Olympus Corporation of the Americas

Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B

Medtronic Perfusion Systems

BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

Becton Dickinson & Co.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001737;

Beaver Visitec International, Inc.

VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700

Biomerieux Inc

KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e

Pro-Dex Inc

Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080

Abbott

MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71

Micro-X Ltd.

CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510

Cardinal Health 200, LLC

Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) A

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in),

Medtronic Perfusion Systems

Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Re

Meridian Bioscience Inc

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These ins

Olympus Corporation of the Americas