Medical Device Recalls

Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic devi

Philips North America Llc

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.

Baxter Healthcare Corporation

Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE

MEDLINE INDUSTRIES, LP - Northfield

BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are

Becton, Dickinson and Company, BD Biosciences

ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF:

Siemens Medical Solutions USA, Inc.

MicroScan WalkAway-96 plus Instrument REF B1018-284

Beckman Coulter Inc.

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.

Olympus Corporation of the Americas

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781065

TELEFLEX LLC

CRT-D DTBB2Q1 VIVA QUAD S IS4/DF1 INTL, Model Number DTBB2Q1; Implantable Cardioverter Defibrillators

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

URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581

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

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Cus

Merit Medical Systems, Inc.

Achieva TX Interventional Coil 3.0T

Philips North America Llc

Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

Baxter Healthcare Corporation

Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC

MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, M

Medtronic MiniMed

HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology

Stradis Healthcare

A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate, 12-Hole, Left. Inended for Fixation of fr

Tyber Medical

Allura Xper FD20; Model Number: 722006;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709

Howmedica Osteonics Corp.

All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00

CareFusion 303, Inc.

Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230

Medline Industries, LP

Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

MORRISON MEDICAL Morrison Medical OB KIT, HARD PK SEALED W/CARDBOARD BX MORMED Catalog #0967NL

Mckesson Medical-Surgical Inc. Corporate Office

Philips S7-3t Transducer.

Philips Ultrasound, Inc

Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED551

MICROVENTION INC.

Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, produ

Aesculap Implant Systems LLC

WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intende

Boston Scientific Corporation

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monit

Edan Diagnostics

Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for a

Sysmex America, Inc.