Medical Device Recalls

Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals

Baxter Healthcare Corporation

Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only

Cordis US Corp

OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pum

Abiomed, Inc.

Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47

Exactech, Inc.

ACCOLADE DR SL MRI (Model L311)

Boston Scientific Corporation

MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan

Beckman Coulter, Inc.

HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Techno

Stradis Healthcare

Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK ; 2) DYNJ59573A , Pack Number ICU RESPI

MEDLINE INDUSTRIES, LP - Northfield

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. LIVE

MEDLINE INDUSTRIES, LP - Northfield

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

B Braun Medical Inc

Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the b

Integra LifeSciences Corp.

Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system ca

Philips North America Llc

Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40

Shimadzu Medical Systems

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.

DEPUY (IRELAND)

Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST

Remel Inc

EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and ado

Olympus Corporation of the Americas

Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 2) TRIPLE LUMEN CENTRAL LIN

Medline Industries, LP

Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF

MEDLINE INDUSTRIES, LP - Northfield

MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS, REF CDS941061M; 3) NEURO P

Medline Industries, LP

Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGI

Medline Industries, LP

Incisive CT Plus-Computed Tomography X-Ray System Model: 728149

Philips North America

AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.

Integra LifeSciences Corp.

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO S

Smiths Medical ASD Inc.

Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with

Belmont Instrument LLC

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ9

Medline Industries, LP

CRTD DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G; Implantable Cardioverter Defibrillators

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

3M COMPANY 3M PAD, GROUNDING SAFETY RING Model Number: 9165

Mckesson Medical-Surgical Inc. Corporate Office

Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214

Cook Incorporated

Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software V

Exactech, Inc.

Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargea

Medtronic Neuromodulation