BEUDAMED
    31 results · 13ms · 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 × Status: Open, Classified × Clear all

    STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.

    FDA Recall
    Open, Classified ·Product code JIN·October 2, 2023

    Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP

    FDA Recall
    Open, Classified ·EHOB, Inc.·Product code IKY·April 19, 2021

    Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.

    FDA Recall
    Open, Classified ·Medline Industries Inc·Product code JIN·March 15, 2021

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

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

    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

    ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207; ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes, REF: 20325-248; Hybrid CO2 Tubing/Cap Set for Fujinon Scopes, REF: 20325-208

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

    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

    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

    Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

    FDA Recall
    Open, Classified ·IHB OPERATIONS B.V. Floresstraat 52 Zwolle Netherlands·Product code FQO·March 27, 2025

    Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm part numbers 42A-43L, 42A-43M, 42A-43H, and 42A-43S. Ceiling mounted utilities and equipment dispensing system.

    FDA Recall
    Open, Classified ·IHB OPERATIONS B.V. Floresstraat 52 Zwolle Netherlands·Product code FQO·July 19, 2023

    IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·November 4, 2022

    SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S10001

    FDA Recall
    Open, Classified ·Coltene Whaledent Inc·Product code EFB·January 20, 2023

    Food Allergy Panel Test (IgE)

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DHB·November 3, 2025

    Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·October 6, 2025

    3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2); Siemens Material Number (SMN): 10380875; Catalog Number: L2KUN6;

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·October 6, 2025

    Food Sensitivity Test Large

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DHB·November 3, 2025

    Pet Allergy Test

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DHB·November 3, 2025

    Food Intolerance Test Large

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DHB·November 3, 2025

    Portable X-ray system

    FDA Recall
    Open, Classified ·DIGIMED CO., LTD 401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu Seoul Korea (the Republic of)·Product code EHD·June 19, 2025