BEUDAMED
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    Filters FDA Recall × Status: Open, Classified × Clear all

    VIDAS Clostridium Difficile GDH, REF 30125-01

    FDA Recall
    Open, Classified ·bioMerieux, Inc.·Product code MCB·September 22, 2021

    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL KNEE, Medline kit SKU DYNJ909643F.

    FDA Recall
    Open, Classified ·Product code OJH·November 26, 2025

    Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. 40" Snap Leadwire, Green; 7. 24" Snap Leadwire, Brown; 8. 40" Snap Leadwire, Brown; 9. 24" Snap Leadwire, Orange; 10. 40" Snap Leadwire, Orange; 11. 24" Snap Leadwire, White; 12. 40" Snap Leadwire, White; 13. 24" Snap Leadwire, Black; 14. 40" Snap Leadwire, Black; 15. 24" Snap Leadwire, Yellow; 16. 40" Snap Leadwire, Yellow; 17. 24" Snap Leadwire, Set of 5; 18. 24" Snap Leadwire, Set of 7; 19. 40" Snap Leadwire, Set of 5; 20. 40" Snap Leadwire, Set of 7; 21. 24" Snap Leadwire, Set of 5; 22. 40" Snap Leadwire, Set of 5; 23. 48" Gold Cup Leadwires, Blue; 24. 48" Gold Cup Leadwires, Red; 25. 48" Gold Cup Leadwires, Green; 26. 48" Gold Cup Leadwires, Brown; 27. 48" Gold Cup Leadwires, Orange; 28. 48" Gold Cup Leadwires, White; 29. 48" Gold Cup Leadwires, Black; 30. 48" Gold Cup Leadwires, Yellow; 31. 48" Gold Cup Leadwires, Set of 5; 32. 48" Gold Cup Leadwires, Set of 8; Product Usage: The snap electrode leads are used in conjunction with disposable electrodes and the Gold Cup electrodes are reusable electrodes and leads. Both types of electrodes and leads are used for evoked potential testing for audiological, neurological and/or vestibular testing. The electrode leads are connected to the main device by the electrode lead connector and the electrode is attached to the patient contact end of electrode lead.

    FDA Recall
    Open, Classified ·GN Otometrics Horskatten 9 Taastrup Denmark·Product code DSA·August 1, 2019

    Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code GEH·August 18, 2025

    ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code GEH·August 18, 2025

    Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use

    FDA Recall
    Open, Classified ·Erbe USA Inc·Product code GEH·February 12, 2026

    Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use

    FDA Recall
    Open, Classified ·Erbe USA Inc·Product code GEH·February 12, 2026

    Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;

    FDA Recall
    Open, Classified ·New Medical Technologies Gmbh Wankdorffeldstrasse·Product code GEH·December 19, 2024

    IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code GEH·March 24, 2025

    Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053

    FDA Recall
    Open, Classified ·AtriCure, Inc.·Product code GEH·November 28, 2023

    Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;

    FDA Recall
    Open, Classified ·New Medical Technologies Gmbh Wankdorffeldstrasse·Product code GEH·December 19, 2024

    Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use

    FDA Recall
    Open, Classified ·Erbe USA Inc·Product code GEH·February 12, 2026

    IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC)

    FDA Recall
    Open, Classified ·Icecure Medical Ltd 7, Ha-Eshel Caesarea Israel·Product code GEH·September 16, 2019

    Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056

    FDA Recall
    Open, Classified ·AtriCure, Inc.·Product code GEH·November 28, 2023

    IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code GEH·March 24, 2025

    IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code GEH·March 24, 2025

    Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code GHH·October 3, 2023

    IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code GEH·March 24, 2025