Medical Device Recalls

Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software V

Edwards Lifesciences, LLC

D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.

Peter Lazic Gmbh

Philips Garbin Ventilator, Model Number 1058180B

Philips Respironics, Inc.

Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150

Advanced Bionics, LLC

Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/

Vyaire Medical

HoverMatt, 39" W x 78" L, REF: HM39SPU-B

Stryker Sustainability Solutions

Menopause Test Cassette (Urine)

Changchun Wancheng Bio-Electron Co., Ltd.

FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System

Abbott Diabetes Care, Inc.

OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32

Exactech, Inc.

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 50MM Item Number: 15-2028/08

Linkbio Corp.

JAGTOME RX 49-30-260-035 Material Number: M00573020

Boston Scientific Corporation

Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP

Edwards Lifesciences, LLC

Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS, c) PC0404NBIO: 4X4CM

Baxter Healthcare Corporation

Allura Xper FD10; Model Number: 722026;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products

Microtek Medical Inc.

ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; Implantable Cardioverter Defibrillators

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

Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.

Abiomed, Inc.

Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBA

MEDLINE INDUSTRIES, LP - Northfield

AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660

Boston Scientific Corporation

HYDRATOME RX 44-30MM/260CM Material Number: M00583050

Boston Scientific Corporation

VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitat

Ortho-Clinical Diagnostics, INc.

X3-1 Transducer Probe

Philips Ultrasound, Inc

3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape

3M Healthcare Business

Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278

B Braun Medical Inc

BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066

Becton Dickinson & Co.

Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr.

Medtronic Perfusion Systems

MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2) HEAD AND NECK, REF CDS984259P; 3) MINOR

Medline Industries, LP

VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01

Biomerieux Inc

Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1

Busse Hospital Disposables, Inc.

Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous

ZOLL Circulation, Inc.