Medical Device Recalls

Model Number S722, ALTRUA 2 DR EL Pacemaker

Boston Scientific Corporation

EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and ado

Olympus Corporation of the Americas

NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, s

Baxter Healthcare Corporation

muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate

Murata Vios, Inc.

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099

Datascope Corp.

Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,

Medline Industries, LP

GEM Premier 5000 PAK; Part No. 00055407504.

Instrumentation Laboratory

Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Mode

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

EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for t

Phadia US Inc

YSIO X.Pree

Siemens Medical Solutions USA, Inc

Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782

Philips North America

Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;

DAYE (ANNE'S DAY LTD)

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

B Braun Medical Inc

STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO

Cardiovascular Systems Inc

20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)

Abbott Vascular

GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegr

LeMaitre Vascular, Inc.

Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING

Medline Industries, LP

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099

Datascope Corp.

MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001

MY01, INC.

stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repai

Wright Medical Technology, Inc.

Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDE

MEDLINE INDUSTRIES, LP - Northfield

TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP

TAS Medical Inc

Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE NITRO Model/Catalog Number: 91859 Product Description: NON-Steri

Jiangsu Shenli Medical Production Co., Ltd.

Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Mod

Alcon Research LLC

ALYON Surgical Lighting System

Steris Corporation

BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/h

Becton Dickinson Infusion Therapy Systems Inc.

GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Aizu Olympus Co., Ltd.

Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambu

iRhythm Technologies, Inc.

ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human seru

Siemens Healthcare Diagnostics, Inc.