BEUDAMED
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    ALDUK IV

    FDA Adverse Event
    Malfunction ·DRÄGERWERK AG & CO. KGAA·Product code CAN·January 13, 2022

    OXYTOTE DTE

    FDA Adverse Event
    Malfunction ·WESTERN/SCOTT FETZER CO.·Product code CAN·March 8, 2022

    *

    FDA Adverse Event
    Injury ·PRECISION MEDICAL, INC.·Product code CAN·December 18, 2002

    GNG (GRAB `N GO) OPTI E-CYLINDER

    FDA Adverse Event
    Malfunction ·PRAXAIR DISTRIBUTION, INC.·Product code CAN·August 15, 2019

    ROSCOE

    FDA Adverse Event
    Injury ·JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY·Product code CAN·January 27, 2022

    LIFE SAFETY PRODUCTS (LSP)

    FDA Adverse Event
    Injury ·ALLIED HEALTHCARE PRODUCTS, INC.·Product code CAN·August 2, 2019

    ROSCOE

    FDA Adverse Event
    Injury ·DANYANG XINYA VALVE CO., LTD·Product code CAN·October 3, 2019

    OXYGEN REGULATOR

    FDA Adverse Event
    Injury ·MADA MEDICAL·Product code CAN·September 28, 2010

    GRAB 'N GO III PORTABLE MEDICAL OXYGEN SYSTEM

    FDA Adverse Event
    Malfunction ·WESTERN/SCOTT FETZER CO.·Product code CAN·August 4, 2010

    LIFE SUPPORT PRODUCTSOXYGEN REGULATOR

    FDA Adverse Event
    Injury ·ALLIED HEALTHCARE PRODUCTS, INC.·Product code CAN·August 23, 2019

    TRI-ANIM AIR OXYGEN BLENDER SMALL

    FDA Adverse Event
    Malfunction ·PRECISION MEDICAL, INC.·Product code CAN·October 22, 2019

    AMVEX GAS REGULATOR (OXYGEN) WITH POWER TAKE OFF

    FDA Adverse Event
    Malfunction ·AMVEX CORPORATION·Product code CAN·September 30, 2010

    Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OOI·April 5, 2022

    Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.

    FDA Recall
    Terminated ·Luminex Corporation·Product code PEN·October 13, 2020

    Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

    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

    Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF 22000, e) AST-GP67, REF 22226, f) AST-P612, REF 22359, g) AST-XN01, REF 410025, h) AST-N222, REF 413083, i) AST-N223, REF 413110, j) AST-N226, REF 413143, k) AST-N248, REF 413397, l) ASR-GN67, REF 413399, m) AST-GN69, REF 413400, n) AST-GN73, REF 413404, o) AST-GN79, REF 413436, p) AST-GN82, REF 413439, q) AST-N261, REF 413753, r) AST-XN06, REF 413944, s) AST-N275, REF 414313, t) AST-GP75, REF 415670, u) AST-N300, REF 416241, v) AST-N308, REF 413913, w) AST-N314, REF 417027, x) AST-N318, REF 417952, y) AST-P643, REF 418671, z) AST-YS08, REF 420739, aa) AST-N348, REF 420856, bb) AST-ST02, REF 420915, cc) AST-ST03, REF 421040, dd) AST-N355, REF 421351, ee) AST-P654, REF 421912, ff) AST-P655, REF 421913, gg) AST-N371, REF 422024, hh) AST-N372, REF 422241, ii) AST-N379, REF 423052,

    FDA Recall
    Terminated ·Organon Teknika Inc·Product code LON·January 11, 2019

    Cervical Intraepithelial Neoplasia (Cin) Test System

    FDA classification
    FDA Class 2 ·Cervical Intraepithelial Neoplasia (Cin) Test System

    The ICS CHARTR EP 200

    FDA Enforcement
    Class II ·Terminated·GN Otometrics·October 30, 2019

    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 Enforcement
    Class II ·Ongoing·GN Otometrics·October 2, 2019