Medical Device Recalls

Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC

MEDLINE INDUSTRIES, LP - Northfield

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H749085262402; cardiac catheter

Boston Scientific Corporation

Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6351

Hobbs Medical, Inc.

ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.

Mckesson Medical-Surgical Inc. Corporate Office

CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Implantable Cardioverter Defibrillators

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

Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"

Carl Zeiss Meditec, Inc.

BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in blood. BD Trucount Tubes are

Becton, Dickinson and Company, BD Biosciences

Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog

Olympus Corporation of the Americas

LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult

Jolife AB

8MM, POTTS SCISSORS, IS4000 REF 470001

Intuitive Surgical, Inc.

Novum IQ Syringe infusion system, Product Code 40800BAXUS

Baxter Healthcare Corporation

Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-powered infusion pump for intravenous (IV) a

B. Braun Medical, Inc.

Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-08

Datascope Corp.

CRE Wireguided 6-8mm 240cm

Boston Scientific Corporation

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray REF: 8888101004H

Covidien LP

FlexLab (FLX); Version: FLX-217-40;

Inpeco S.A.

Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fu

Hologic, Inc

TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running s

Sysmex America, Inc.

OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration o

B. Braun Medical, Inc.

Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380045

TELEFLEX LLC

Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.

Stryker Instruments

Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

Baxter Healthcare Corporation

Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndro

Philips Respironics, Inc.

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL EU + ROW; the system utilizes an inte

Boston Scientific Corporation

Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Softwa

Baxter Healthcare Corporation

Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X

Penner Patient Care, Inc.

Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V; 2) CATARACT CM-LF, Pack Numb

MEDLINE INDUSTRIES, LP - Northfield

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032; cardiac catheter

Boston Scientific Corporation

MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device

Medacta Usa Inc

Breast Plastics Pack, REF BBPL20D

American Contract Systems, Inc.