Medical Device Recalls

CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-cathe

Medos International Sarl

NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP

Stryker Corporation

SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032

Howmedica Osteonics Corp.

Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312

Avanos Medical, Inc.

EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128

Thera Test Laboratories, Inc.

Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators

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

iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbe

Beckman Coulter, Inc.

Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170065

TELEFLEX LLC

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular cat

Medtronic Perfusion Systems

DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)

ConvaTec, Inc

Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system

SEDECAL SA

TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter

GE Healthcare Finland Oy

HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02

American Contract Systems Inc

TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental

STRATASYS LTD

BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container cl

Becton Dickinson & Company

BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.

Philips North America

ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10

ICU Medical, Inc.

Sharesource Connectivity Platform for Use with the Amia Automated PD System

BAXTER HEALTHCARE CORPORATION

Precision CRF; Model Number: 706400;

Philips Medical Systems DMC GmbH

SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAG

MEDLINE INDUSTRIES, LP - Northfield

Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.

LeMaitre Vascular, Inc.

Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.

GE Medical Systems, LLC

ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle as

Olympus Corporation of the Americas

Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72

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

Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch wi

MEDLINE INDUSTRIES, LP - Northfield

Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe

MEDLINE INDUSTRIES, LP - Northfield

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000568;

Beaver Visitec International, Inc.

SM_40HF_B_D_VIR3, Mobile X-ray system

SEDECAL SA