BEUDAMED
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    TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.

    FDA Recall
    Open, Classified ·Trackx Technology Inc·Product code OWB·October 24, 2022

    Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX Snap has a unique set of 2 or more reflective markers. By having unique configurations of reflective markers, it is possible to identify which TrackX Snap is in the field of view of the camera(s). As such, it is also possible to have multiple TrackX Snaps in the field at once and to have different TrackX Snaps for different surgical instruments. The device is considered to be a sterile accessory.

    FDA Recall
    Open, Classified ·Trackx Technology Inc·Product code OWB·September 3, 2024

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Recall
    Open, Classified ·Max Mobility LLC·Product code ITI·August 12, 2025

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Recall
    Open, Classified ·Max Mobility LLC·Product code ITI·August 12, 2025

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Recall
    Open, Classified ·Max Mobility LLC·Product code ITI·December 20, 2024

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Recall
    Open, Classified ·Max Mobility LLC·Product code ITI·December 20, 2024

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Recall
    Open, Classified ·Max Mobility LLC·Product code ITI·August 12, 2025

    Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System)

    FDA Recall
    Open, Classified ·MedicalCommunications GmbH Max-Jarecki-Str. 8 Heidelberg Germany·Product code NFJ·September 9, 2025

    ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35

    FDA Recall
    Open, Classified ·Abbott GmbH Max-Planck-Ring 2 Wiesbaden Germany·Product code MZO·March 4, 2024

    Alinity i Anti-HCV Reagent Kit, List Number 08P0521

    FDA Recall
    Open, Classified ·Abbott GmbH Max-Planck-Ring 2 Wiesbaden Germany·Product code MZO·March 4, 2024

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code ITX·November 10, 2022

    Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue

    FDA Recall
    Open, Classified ·Scrip Inc·Product code ITX·August 18, 2021

    EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU

    FDA Recall
    Open, Classified ·Red Medical Supplies·Product code ITX·August 11, 2021

    ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1

    FDA Recall
    Open, Classified ·ImaCor Inc.·Product code ITX·September 16, 2024

    Philips X5-1 Transducer.

    FDA Recall
    Open, Classified ·Philips Ultrasound, Inc·Product code ITX·May 28, 2025

    Philips L12-4 Transducer.

    FDA Recall
    Open, Classified ·Philips Ultrasound, Inc·Product code ITX·May 28, 2025

    Philips L9-3 Transducer.

    FDA Recall
    Open, Classified ·Philips Ultrasound, Inc·Product code ITX·May 28, 2025

    SCNHD LA L7-4 HDI Transducer Probe

    FDA Recall
    Open, Classified ·Philips Ultrasound, Inc·Product code ITX·July 3, 2025

    Philips Mini Multi TEE Ultrasound Transducer

    FDA Recall
    Open, Classified ·Philips Ultrasound, Inc·Product code ITX·September 5, 2025

    Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code ITX·September 25, 2023