Medical Device Recalls

HeartWare HVAD Pump Kit, REF 1104

Heartware, Inc.

Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072

Baxter Healthcare Corporation

Recreo Hair Growth Laser Comb

OMM Imports, Inc. dba Zero Gravity

PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 1

B BRAUN MEDICAL INC

Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d)

Advance Medical Designs, Inc.

Baxter Solution Set with Duo-Vent Spike, REF 2R8404

Baxter Healthcare Corporation

i-STAT EG7+ cartridge; List Number: 03P76-25;

Abbott Point Of Care Inc.

10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 /

Merit Medical Systems, Inc.

026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in h

Fresenius Medical Care Holdings, Inc.

Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engst

GE Healthcare, LLC

Colonoscope, Model Number CF-HQ190I.

Olympus Corporation of the Americas

HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.

Mckesson Medical-Surgical Inc. Corporate Office

MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.

MEDLINE INDUSTRIES, LP - Northfield

Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The M

Merge Healthcare, Inc.

eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158

Civco Medical Instruments Co. Inc.

TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C

American Contract Systems Inc

Washer Disinfector Aquadis 56; Model Number: 56A

Getinge Disinfection Ab

Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerot

Arrow International Inc

RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928

Howmedica Osteonics Corp.

FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)

Inpeco S.A.

NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.

bioMerieux, Inc.

ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system

Siemens Medical Solutions USA, Inc

Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY.

B BRAUN MEDICAL INC

3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape

3M Healthcare Business

Positron Emission Tomography and Computed Tomography System, Model: uMI 550

Shanghai United Imaging Healthcare Co., Ltd.

11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video

Karl Storz Endoscopy

MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONE

Integra LifeSciences Corp. (NeuroSciences)

Stimulen Collagen Moisturizing Lotion, ST9555B

Southwest Technologies Inc

Stereo Breast Biopsy Tray Catalog Number: 2383R1

Busse Hospital Disposables, Inc.

Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Numbe

MEDLINE INDUSTRIES, LP - Northfield