BEUDAMED
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    Automated Impella Controller (AIC); Product Code: 0042-0000-US;

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code OZD·April 20, 2026

    human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.

    FDA Recall
    Open, Classified ·HUMAN MED AG Wilhelm-Hennemann-Str. 9 Schwerin Germany·Product code QPB·October 18, 2024

    HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type

    FDA Recall
    Open, Classified ·Haimen Shengbang Laboratory Equipment Co. Ltd. D, Sanhe No. 50 Xue Qian Road; Sanhezhen Haimen Nantong China·Product code QMC·July 12, 2022

    HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made

    FDA Recall
    Open, Classified ·Haimen Shengbang Laboratory Equipment Co. Ltd. D, Sanhe No. 50 Xue Qian Road; Sanhezhen Haimen Nantong China·Product code QMC·July 12, 2022

    HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1

    FDA Recall
    Open, Classified ·Haimen Shengbang Laboratory Equipment Co. Ltd. D, Sanhe No. 50 Xue Qian Road; Sanhezhen Haimen Nantong China·Product code QMC·July 12, 2022

    Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code JAK·May 20, 2022

    VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only

    FDA Recall
    Open, Classified ·bioMerieux, Inc.·Product code LON·June 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

    CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNTURN Catalog # CKF105L

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code FCN·May 25, 2022

    VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266

    FDA Recall
    Open, Classified ·Ortho Clinical Diagnostics Inc·Product code CGN·July 12, 2018

    Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs Model Number: TGF-UC180J.

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

    Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FBN·December 18, 2024

    Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 11206252

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023

    Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023

    Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023

    VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code CGN·July 3, 2024

    Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, LUER LOCK SAMPLING PORT, A/R DEVICE, DRAIN SPOUT, PREP TRAY; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M FOLEY TRAY, COUD TIP, 16FR (5.3 MM), 5CC; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG (2-person); Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M FOLEY TRAY, COUD TIP, 18FR (6.0 MM), 5CC; Dover" PREMIUM URINE DRAINAGE ADD-A-FOLEY TRAY, LUER-LOCK, DRAIN SPOUT, CATHETER SECUREMENT DEVICE

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code FCN·December 4, 2023

    Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.

    FDA Recall
    Open, Classified ·TANGENT ENDOSCOPY, LLC·Product code FBN·March 23, 2026