Medical Device Recalls

Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) Sys

Medtronic Inc

Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is

ICU Medical Inc

20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR

Smiths Medical Asd Inc

CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and

Immuno-Mycologics, Inc

Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A

Medline Industries, LP

POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such sur

Olympus Corporation of the Americas

Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems T

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test i

BioFire Diagnostics, LLC

NOxBOXi Nitric Oxide Delivery System

NOXBOX LTD

Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Softw

Draeger, Inc.

stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades

Stryker Corporation

GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150035

TELEFLEX LLC

Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789

Cook Incorporated

FlexLab (FLX); Version: FLX-217-10;

Inpeco S.A.

Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunc

Stryker Corporation

Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360

Steris Corporation

Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D0151

Bard Access Systems, Inc.

OEC 3D

GE Medical Systems, LLC

Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applicatio

Olympus Corporation of the Americas

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001865;

Beaver Visitec International, Inc.

VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342

Biomerieux Inc

Allura Xper FD20/15; System Code: 722058;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Hobbs Biliary Pigtail Stent Kits Catalog Number: 6105

Hobbs Medical, Inc.

ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and ches

Maquet Cardiovascular, LLC

PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extr

Entopsis , Inc.

Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.

Olympus Corporation of the Americas

NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/

Medline Industries, LP

JAGTOME RX 39-20-260-025 Material Number: M00573080

Boston Scientific Corporation

To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10

Universal Meditech Inc.