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    McKesson Cardiology Hemo software

    FDA Recall
    Open, Classified ·A L I Technologies Ltd·Product code MWI·December 2, 2024

    Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T-03201

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code PPD·December 4, 2025

    Atlan A350XL. Model Number: 8621600. anesthesia workstation

    FDA Recall
    Open, Classified ·Draeger, Inc.·Product code BSZ·May 7, 2026

    Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES

    FDA Recall
    Open, Classified ·Vortex Surgical Inc.·Product code KDD·December 16, 2025

    EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5

    FDA Recall
    Open, Classified ·Staar Surgical AG Haupt Strasse 104 Nidau Switzerland·Product code QCB·January 21, 2026

    Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038

    FDA Recall
    Completed ·ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy·Product code ITX·March 14, 2025

    smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code LJT·February 13, 2025

    smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code LJT·February 13, 2025

    AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code KNS·December 20, 2024

    NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.

    FDA Recall
    Open, Classified ·Northeast Scientific Inc.·Product code QTF·August 29, 2025

    Hospira brand Symbiq One-Channel Infuser LIST No. 16026 Symbiq One-Channel Infuser, List Number Configurations: 16026-04-01/03/04,51/52, 53/54, 79/80, 81/82, 83/84, 87/88 and 89/90, 16026-13-25/26, 53/54, Distributed by: Hospira, Inc. Morgan Hill, CA

    FDA Recall
    Terminated ·Hospira Inc·Product code FRN·February 22, 2010

    Enpath Lead Adapters, pacemaker lead adapter. Affects: 5 mm Bipolar, Model 501205; 6 mm Unipolar, Model 501204; 3.2 mm Low-Profile Bipolar Models 501206 and 501214. All labeled Sterile, EO, mail: Enpath Medical, Inc. Lead Technologies Division, Minneapolis, MN 55439 USA.

    FDA Recall
    Terminated ·Enpath Medical, Inc·Product code DTB·July 18, 2006

    STERRAD NX Sterilizer, Product Code: 10033, Advanced Sterilization Products, Irvine, CA

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code MLR·November 12, 2007

    remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm name on the label is Remel, Lenexa, KS. The product is a solid medium recommended for use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase-resistant penicillins (PRP, e.g. methicillin, nafcillin, and oxacillin).

    FDA Recall
    Terminated ·Remel, Inc·Product code JTZ·December 8, 2009

    Restoration Modular Hip System; Proximal Cone Body; 23 mm +0 mm (STD); Not for use with + 16 V40 femoral Head. For Cementless Use Only. Stryker Orthopaedics. Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LZO·June 26, 2009

    Restoration Modular Hip System; Proximal Cone Body; 23 mm +20 mm; Not for use with + 16 V40 femoral Head. For Cementless Use Only. Stryker Orthopaedics. Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LZO·June 26, 2009

    AxSYM total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent.

    FDA Recall
    Terminated ·Abbott Health Products, Inc.·Product code JHI·March 24, 2005

    Precision Bipolar Device ClearGlide EVH Small (endoscopic vessel harvesting system) The kit included three Precision BiPolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor and a Vessel Dissector. Datascope Cardiac Assist Sterile R Manufactured for: Datascope Cardiac Assist 15 Law Drive Fairfield, NJ 07004

    FDA Recall
    Terminated ·Datascope Corporation·Product code GEI·May 7, 2007

    Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures. The product is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography procedures. These systems can be operated in a mobile or fixed site environment.

    FDA Recall
    Terminated ·GE Healthcare·Product code MQB·June 24, 2008

    Lumi 8 Intense LED Light Facial System, Sybaritic, Inc.,9220 James Ave South Minneapolis, Minnesota 55431., Mode of Operation: Operation with Intermittent/continuous load, Visible and Invisible LED Radiation, Class 3R LED Product, Refer to IEC 60825-2001 for further information., Input: 100 -230 V AC 50/60 HZ Power Input: 1509 V A....Protective Eyewear required Wavelength 590 & 630 nm.

    FDA Recall
    Terminated ·Sybaritic, Inc·Product code OHS·June 18, 2008