Medical Device Recalls

Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678

Cook Incorporated

Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457

Integra LifeSciences Corp.

Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST

Remel Inc

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

B Braun Medical Inc

medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T

Smiths Medical ASD, Inc.

Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fis

Cook Biotech, Inc.

Discovery MR750w 3.0T, whole body magnetic resonance scanner

GE Medical Systems, LLC

TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental

STRATASYS LTD

NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device

NOXBOX LTD

Philips L12-4 Transducer.

Philips Ultrasound, Inc

HARDY DIAGNOSTICS CatScreen, 25dsk/vial

MEDLINE INDUSTRIES, LP - Northfield

Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.

Philips North America

TOTAL KNEE -Procedure Kit Catalog Number: QPTK95B

American Contract Systems Inc

FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the Fr

Abbott Diabetes Care, Inc.

Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT

Philips North America Llc

6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutt

The Anspach Effort, Inc.

Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU

ARROW INTERNATIONAL, LLC

Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style

Healthmark Industries Co., Inc.

Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily adjust/control the c

Hill-Rom, Inc.

HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of

Boston Scientific Corporation

Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version:

Thoratec LLC

Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461

Agilent Technologies Denmark ApS

METREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS) Model Number: 10-4025

Mckesson Medical-Surgical Inc. Corporate Office

BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981

Becton Dickinson & Co.

Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.

TEI Biosciences, Inc.

CareFusion V.Mueller GENESIS LARGE, CONTAINER 28 X 11" (71.1 X 27.9CM) 6" (15.2CM) DEEP, PERFORATED STERRAD COMPATIBLE,

Carefusion 2200 Inc

Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;

Philips North America Llc

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

Smiths Medical ASD, Inc.

GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24

Smiths Medical ASD, Inc.