BEUDAMED
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    Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2, SP9 and SP9.0.1 display o orientation markers can become is incorrect.

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code LLZ·November 9, 2018

    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157

    FDA Recall
    Completed ·Bioseal Corporation·Product code KDD·March 23, 2021

    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096

    FDA Recall
    Completed ·Bioseal Corporation·Product code KDD·March 23, 2021

    Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177

    FDA Recall
    Completed ·Bioseal Corporation·Product code KDD·March 23, 2021

    Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.

    FDA Recall
    Completed ·Biosense Webster, Inc.·Product code DYB·February 26, 2021

    Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed. The Obalon Balloons are administered using the Navigation System.

    FDA Recall
    Completed ·Obalon Therapeutics Inc·Product code LTI·May 23, 2019

    Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.

    FDA Recall
    Completed ·Biosense Webster, Inc.·Product code DYB·February 26, 2021

    Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016260 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.

    FDA Recall
    Completed ·Biosense Webster, Inc.·Product code DYB·February 26, 2021

    ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150

    FDA Recall
    Completed ·Product code MNT·December 12, 2019

    4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010

    FDA Recall
    Completed ·Acumed LLC·Product code HWC·March 9, 2022

    4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012

    FDA Recall
    Completed ·Acumed LLC·Product code HWC·March 9, 2022

    POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 8F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; NAUTILUS DELTA Tip Confirmation System (Includes: Netbook with Pre-loaded Software, Patient Module, and ECG Cable) Product Usage: Is an implantable access device designed to provide repeated access to the vascular system.

    FDA Recall
    Completed ·Bard Peripheral Vascular Inc·Product code LJT·June 25, 2018

    INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup

    FDA Enforcement
    Class II ·Completed·Innomed, Inc.·May 8, 2024

    iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.

    FDA Enforcement
    Class III ·Completed·Iotamotion Inc·November 13, 2024

    Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster). Provide mobility to individuals limited to a seating position.

    FDA Enforcement
    Class II ·Completed·CHENICA INC.·February 20, 2013

    Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tray Trial, Cat. #321-00-11; (4) HAT LAT Right Tray Trial, Cat. #321-00-12; (5) HAT EXT LAT Left Trial, Cat. #321-00-21; and (6) HAT EXT LAT Right Trial, Cat. #321-00-22. The Humeral Augmented Tray is designed to function with the Equinoxe Reverse Shoulder System orthopedic implant components.

    FDA Enforcement
    Class II ·Completed·Exactech, Inc.·July 7, 2021

    LYFO Disk

    FDA Enforcement
    Class III ·Completed·Microbiologics Inc·March 23, 2022

    Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates

    FDA Enforcement
    Class II ·Completed·IMMUNDIAGNOSTIK, Inc·May 24, 2023

    Medtronic SynchroMed, Model A10

    FDA Enforcement
    Class II ·Completed·Medtronic Inc.·December 20, 2023

    iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101

    FDA Enforcement
    Class II ·Completed·Conformis, Inc.·April 20, 2022