Medical Device Recalls

TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed fo

Echopixel, Inc.

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.

Olympus Corporation of the Americas

Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320

Avanos Medical, Inc.

Atrium Oasis Drain Single W / AC, Part No. 3600-100

Atrium Medical Corporation

EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator

Medtronic Inc.

Artis zee floor MN, Model Number 10094142

Siemens Medical Solutions USA, Inc

MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02

American Contract Systems Inc

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110

Medtronic Perfusion Systems

Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product

ICU Medical Inc.

Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the qu

Siemens Healthcare Diagnostics, Inc.

Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM AN

Medline Industries, LP

Signa 1.5T TwinSpeed Magnetic Resonance Imaging System

GE Healthcare, LLC

Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYN

Medline Industries, LP

Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FA

Cardinal Health 200, LLC

RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.

Siemens Healthcare Diagnostics Inc

Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

Baxter Healthcare Corporation

HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31

I.T.S. GmbH

LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500

MEDLINE INDUSTRIES, LP - Northfield

Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

Abbott Medical

SIGNA Premier magnetic resonance scanner, model 5748519.

GE Healthcare, LLC

Estrone RIA, REF: DSL8700

Immunotech A.S.

Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number:

Hologic, Inc

ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabiliti

ZOLL Circulation, Inc.

Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06

AVID Medical, Inc.

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter

Boston Scientific Corporation

GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000

Wipro GE Healthcare Private Ltd.

ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.

TERRAGENE S.A.

Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL

Shimadzu Corp. Analytical & Measuring Instruments Div.

IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio

IMPRIS Imaging Inc