Medical Device Recalls

EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160

Olympus Corporation of the Americas

Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt

Medtronic, Inc.

MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418

MEDLINE INDUSTRIES, LP - Northfield

BIB Balloon in Balloon Dilatation Catheter. Model Number: 420

Numed Inc

MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Produc

DJO, LLC

BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9

CareFusion 303, Inc.

Allergy Test IgE

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Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mi

Siemens Healthcare Diagnostics, Inc.

LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.

Datascope Corporation

Allergy test Small

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Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

Zimmer, Inc.

Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Articl

B Braun Medical Inc

OASIS MRI System

Hitachi Healthcare Americas Corporation

Apo B Reagent, REF: OSR6143

Beckman Coulter Ireland, Inc.

Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been c

Flower Orthopedics Corporation

Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can

Philips North America Llc

L12-5 38mm Transducer Probe

Philips Ultrasound, Inc

HemosIL SynthAFax. Partial Thromboplastin Time Tests.

Instrumentation Laboratory

Burlington Medical, Wrap Aprons.

Burlington Medical, LLC

EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light

Olympus Corporation of the Americas

Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008

Cytocell Ltd.

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-

Fresenius Kabi USA, LLC

Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Catalog Number: 8065992747 Software Version:

Alcon Research LLC

BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433

CAREFUSION

Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL

Stryker Corporation

Achieva 3.0T, Magnetic Resonance System.

Philips North America Llc

Hobbs Transbronchial Aspiration Needle Catalog Number: 4621

Hobbs Medical, Inc.

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat

B Braun Medical Inc

CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators

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