Medical Device Recalls

EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: EN

Bard Peripheral Vascular Inc

Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description

Trividia Health, Inc.

Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit

American Contract Systems, Inc.

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX

Datascope Corp.

Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infu

Integra LifeSciences Corp. (NeuroSciences)

Medtronic SynchroMed II, Model 8637-40, Programmable pump

Medtronic Neuromodulation

One Step P in vitro diagnostic test REF: 8194

DFI Co., Ltd.

Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm

Acumed LLC

Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system

CareFusion 303, Inc.

ROBOTIC PROSTATECTOMY PACK. Medical convenience kit.

AVID Medical, Inc.

Blood/MacConkey Biplate 100/PK, Product Number R02049

Remel, Inc

a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest INDICATOR, CHEMICAL VAPORIZ

Mckesson Medical-Surgical Inc. Corporate Office

EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in a

Olympus Corporation of the Americas

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Soft

RAYSEARCH LABORATORIES AB

Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYN

MEDLINE INDUSTRIES, LP - Northfield

MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) M

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR

Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC

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

MEDLINE INDUSTRIES, LP - Northfield

FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, che

FUJIFILM Healthcare Americas Corporation

Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version: 2.

Pride Mobility Products Corp.

PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413

Howmedica Osteonics Corp.

Nerve Block Tray Catalog Number: 9342

Busse Hospital Disposables, Inc.

Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25500QS

Medline Industries, LP

Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12

TECHNO-PATH MANUFACTURING LTD.

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

Zimmer, Inc.

Anesthesia Circuit Kit Coax 3, MP02732

Draeger Medical, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001123;

Beaver Visitec International, Inc.

BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)

Becton Dickinson & Company

Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Mo

Tyber Medical