Medical Device Recalls

LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000

Physio-Control, Inc.

SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/C

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor t

Mechatronics USA

Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;

Philips North America

Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2

Baxter Healthcare Corporation

ANCILLARY PACK-LF. Sterile Procedural Tray.

MEDLINE INDUSTRIES, LP - Northfield

Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.

Philips North America

GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.

GE Medical Systems China Co., Ltd.

CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary

St. Jude Medical

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011

Cardinal Health

Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219

DeRoyal Industries Inc

Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Ca

Merit Medical Systems, Inc.

Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:A

Medtronic Vascular, Inc.

Cysto, FTCY03L; Medical convenience kit

American Contract Systems, Inc.

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Pa

UIH Technologies LLC

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH

MEDLINE INDUSTRIES, LP - Northfield

Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101

ASPEN SURGICAL

8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344

Intuitive Surgical, Inc.

Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system

SEDECAL SA

Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavi

I.T.S. GmbH

basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or othe

Merit Medical Systems, Inc.

MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATAR

MEDLINE INDUSTRIES, LP - Northfield

BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (

Becton Dickinson & Company

SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512

Howmedica Osteonics Corp.

SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524

Howmedica Osteonics Corp.

MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L

Medline Industries, LP

My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Sho

Onkos Surgical, Inc.

Model Number L121 ESSENTIO DR EL Pacemaker

Boston Scientific Corporation

Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fi

Cook Biotech, Inc.