Medical Device Recalls

Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designe

Olympus Corporation of the Americas

Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra o

Philips North America Llc

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes a

Boston Scientific Corporation

Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus of

United Orthopedic Corp.

Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD

Cardinal Health 200, LLC

Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack N

MEDLINE INDUSTRIES, LP - Northfield

Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE

Cook Incorporated

Focalyx Fusion

Focalyx Technologies, LLC.

CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5061

Carefusion 2200 Inc

PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE

Universal Meditech Inc.

Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY

Merit Medical Systems, Inc.

Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain

The Metrix Company

DxC 700 AU, REF: B86444, B86446

Beckman Coulter Mishima K.K.

SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system

Surgical Theater Inc

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DY

MEDLINE INDUSTRIES, LP - Northfield

IUD Insertion Pack

Stradis Medical, LLC dba Stradis Healthcare

Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog

Cardinal Health 200, LLC

Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D

Merit Medical Systems, Inc.

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 10) RED Model/Catalog Number: 56

ASP Global, LLC.

Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decort

Stryker Corporation

Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.

Baxter Healthcare Corporation

ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27

Abbott Laboratories

HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205

Heartware, Inc.

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline

Medline Industries, LP

Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 Syst

LivaNova Deutschland GmbH

Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E8

GE Medical Systems, LLC

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20

Beckman Coulter, Inc.

Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN

Olympus Corporation of the Americas

Brand Name: MEDLINE Product Name: SYR 10ML L/L RED CONT Model/Catalog Number: 91856 Product Description: NON-Sterile

Jiangsu Shenli Medical Production Co., Ltd.