Medical Device Recalls

Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-281

Waldemar Link GmbH & Co. KG (Mfg Site)

Diasol Acid Concentrate REF G100325-10Dex 100

Diasol, Inc

Fecal Occult Blood Test

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TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue remo

Covidien Llc

Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,

MEDLINE INDUSTRIES, LP - Northfield

Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from clear

Boston Scientific Corporation

IntelliVue Patient Monitor MX750. Product Number: 866471.

Philips North America Llc

Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.

AVID Medical, Inc.

Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238

Stryker Neurovascular

Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Number: 8065772465 Software Version: N/A Pr

Alcon Research LLC

20" Lead Wires, Replacement Part Number: 1067724-2

EBI, LLC

Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is

Baxter Healthcare Corporation

Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Prime

Ultradent Products, Inc.

Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in man

Remote Diagnostic Technologies Ltd.

MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites

Cordis US Corp

Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-06

AVID Medical, Inc.

medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543

Smiths Medical ASD, Inc.

medex TranStar Disposable Transducer 1/EA, Product Code REF MX950

Smiths Medical ASD, Inc.

Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid fo

Medtronic Navigation, Inc.

GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be us

Northgate Technologies, Inc.

Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained

Zimmer, Inc.

Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A P

Ultradent Products, Inc.

Allia IGS 7 Pulse angiographic X-ray system

GE Medical Systems, LLC

Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A

Medline Industries, LP

VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibra

Ortho-Clinical Diagnostics, Inc.

Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Mode

Intuitive Surgical, Inc.

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as STERILE SET FOR IMPLANT-LF

MEDLINE INDUSTRIES, LP - Northfield

Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.

Burlington Medical, LLC

SMV DSX New Line, System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING