BEUDAMED
    67 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    Torrent" irrigation tubing. Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.

    FDA Recall
    Terminated ·US Endoscopy Group Inc·Product code OCX·March 7, 2013

    STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.1

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222

    FDA Recall
    Open, Classified ·Erbe Medical, LLC·Product code OCX·March 31, 2026

    Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190

    FDA Recall
    Open, Classified ·Hobbs Medical, Inc.·Product code OCX·July 29, 2022

    Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191

    FDA Recall
    Open, Classified ·Hobbs Medical, Inc.·Product code OCX·July 29, 2022

    Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code OCX·January 14, 2015

    Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the accessory port throughout the gastrointestinal endoscopic procedure. The Velocity biopsy valve provides a connection for irrigation through the Velocity irrigation pump.

    FDA Recall
    Terminated ·US Endoscopy Group Inc·Product code OCX·February 17, 2015

    Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;

    FDA Recall
    Open, Classified ·Erbe Medical, LLC·Product code OCX·March 31, 2026

    Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milwaukee, WI 53212 USA Product Code: 1203-71

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degrees, Part #325-07102510, nonsterile; (3) Calibrate CCX-O, 7 x 10 x 25mm 15 degrees, Part #325-07102515, nonsterile; (4) Calibrate CCX-O, 7 X 10 X 30mm 5 degrees, Part #325-07103005, nonsterile; (5) Calibrate CCX-O, 7 x 10 x 30mm 10 degrees, Part #325-07103010, nonsterile; (6) Calibrate CCX-O, 7 x 10 x 30mm 15 degrees, Part #325-07103015, nonsterile; (7) Calibrate CCX-O, 7 x 10 x 35mm 10 degrees, Part #325-07103510, nonsterile; (8) Calibrate CCX-O, 7 x 10 x 35mm 15 degrees, Part #325-07103515, nonsterile; (9) Calibrate CCX-O, 9 x 10 x 25mm 5 degrees, Part #325-09102505, nonsterile; (10) Calibrate CCX-O, 9 x 10 x 25mm 10 degrees, Part #325-09102510, nonsterile; (11) Calibrate CCX-O, 9 x 10 x 30mm 5 degrees, Part #325-09103005, nonsterile; (12) Calibrate CCX-O, 9 x 10 x 30mm 10 degrees, Part #325-09103010, nonsterile; (13) Calibrate CCX-O, 11 x 10 x 30mm 10 degrees, Part #325-11103010, nonsterile; (14) Calibrate CCX-S, 7 x 10 x 22mm 5 degrees, Part #326-07102205, nonsterile; (15) Calibrate CCX-S, 7 x 10 x 22mm 10 degrees, Part #326-07102210, nonsterile; (16) Calibrate CCX-S, 7 x 10 x 22mm 15 degrees, Part #326-07102215, nonsterile; (17) Calibrate CCX-S, 7 x 10 x 26mm 5 degrees, Part #326-07102605, nonsterile; (18) Calibrate CCX-S, 7 x 10 x 26mm 10 degrees, Part #326-07102610, nonsterile; (19) Calibrate CCX-S, 7 x 10 x 26mm 15 degrees, Part #326-07102615, nonsterile; (20) Calibrate CCX-S, 7 x 10 x 30mm 10 degrees, Part #326-07103010, nonsterile; (21) Calibrate CCX-S, 9 x 10 x 22mm 5 degrees, Part #326-09102205, nonsterile; (22) Calibrate CCX-S, 9 x 10 x 22mm 10 degrees, Part #326-09102210, nonsterile; (23) Calibrate CCX-S, 9 x 10 x 26mm 5 degrees, Part #326-09102605, nonsterile; (24) Calibrate CCX-S, 9 x 10 x 26mm 10 degrees, Part #326-09102610, nonsterile; and (25) Calibrate CCX-S, 11 x 10 x 26mm 10 degrees, Part #326-11102610, nonsterile. Convenience kits containing affected implants: (1) Calibrate CCX Oblique Implants, REF CLCCXOIMPA, containing 24 implants/kit, nonsterile; and (2) Calibrate CCX Straight Implants, REF CLCCXSIMPA, containing 36 implants/kit, nonsterile.

    FDA Recall
    Open, Classified ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code MAX·December 15, 2024

    CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC

    FDA Recall
    Open, Classified ·Terumo Cardiovascular Systems Corporation·Product code DTZ·March 1, 2023