Medical Device Recalls

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001501;

Beaver Visitec International, Inc.

Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 810

Sol-Millennium Medical Inc.

Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly

Merit Medical Systems, Inc.

MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008

GE Healthcare, LLC

CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators

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

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

Datascope Corp.

HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089

Stradis Medical, LLC dba Stradis Healthcare

Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile

Folsom Metal Products, Inc.

LAVH, REF BBLV21C

American Contract Systems, Inc.

G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip

Zimmer, Inc.

Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A

Stryker Sustainability Solutions

MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery

Megadyne Medical Products, Inc.

DeRoyal SHOULDER KIT, REF 89-9497.08

DeRoyal Industries Inc

Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthc

Turbett Surgical, Inc.

GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.

GE Medical Systems China Co., Ltd.

LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. No

Cardiac Assist, Inc

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07

Linkbio Corp.

Organic Acids Profile Test Large

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EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160

Olympus Corporation of the Americas

Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt

Medtronic, Inc.

MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418

MEDLINE INDUSTRIES, LP - Northfield

BIB Balloon in Balloon Dilatation Catheter. Model Number: 420

Numed Inc

MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Produc

DJO, LLC

BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9

CareFusion 303, Inc.

Allergy Test IgE

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Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mi

Siemens Healthcare Diagnostics, Inc.

LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.

Datascope Corporation

Allergy test Small

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

Zimmer, Inc.