BEUDAMED
    462 results · 12ms · 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

    Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648;

    FDA Recall
    Open, Classified ·Bayer Medical Care, Inc.·Product code DXT·April 24, 2026

    Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4

    FDA Recall
    Open, Classified ·Daavlin Distributing Company·Product code FTC·December 10, 2025

    NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code LGZ·August 6, 2021

    LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.

    FDA Recall
    Open, Classified ·Magellan Diagnostics, Inc.·Product code DOF·September 19, 2023

    (1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit, (4)LeadCare II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) " Heparinized Capillary Tubes/Plungers (50 @) " Transfer Droppers (50 @) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)

    FDA Recall
    Open, Classified ·Magellan Diagnostics, Inc.·Product code DOF·March 13, 2026

    LeadCare Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)

    FDA Recall
    Open, Classified ·Magellan Diagnostics, Inc.·Product code DOF·March 13, 2026

    LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)

    FDA Recall
    Open, Classified ·Magellan Diagnostics, Inc.·Product code DOF·March 13, 2026

    MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01

    FDA Recall
    Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

    MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01

    FDA Recall
    Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

    MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01

    FDA Recall
    Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

    MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare II General Chemistry Blood Lead Test Whole Blood Sample 48 Tests Model Number: 70-6762

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

    MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01

    FDA Recall
    Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

    The LeadCare II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare II Test Kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) " Heparinized Capillary Tubes/Plungers (50) " Transfer Droppers (50) " Calibration Button (1) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)

    FDA Recall
    Open, Classified ·Magellan Diagnostics, Inc.·Product code DOF·February 23, 2024

    NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code LGZ·August 6, 2021

    FoundationOne Companion Diagnostic (F1CDx)

    FDA Recall
    Open, Classified ·Foundation Medicine, Inc.·Product code PQP·April 9, 2025

    Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 59-320 HAWK Advanced Hypothermia Management Set. Convenience kits labeled as follows: Combat Life Saver - Intermediate (Product Number: 83-323-CB) contains 59-300 / 1 Each; Medic Enhancement Resupply (Product Number: 82-504-05) contains 59-300 / 1 Each; Combat Life Saver - Advanced (Product Number: 83-325-CB) contains 59-300 / 1 Each; Cold Weather (Product Number: 82-505) contains 59-300 / 1 Each; HAWK w/ Carrier Set, Multicam, Stocked (Product Number: 83-315-01-MC) contains 59-300 / 1 Each; Mojo Combat Life Saver - Intermediate - Multicam (Product Number: 83-323-MC); Combat Life Saver - Intermediate - Multicam (Product Number: 83-323-MC); Mojo Combat Life Saver - Advanced - Multicam (Product Number: 83-325-MC); DIRECT ACTION BAG, FOLIAGE GREEN, ADVANCED, STOCKED (Product Number: 84-497-FG).

    FDA Recall
    Open, Classified ·Safeguard US Operating LLC·Product code IMD·August 27, 2024

    Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA - Liatest Free Protein S kits are intended for use on STA-R and STA Compact for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method. Component: Not Applicable

    FDA Recall
    Open, Classified ·Diagnostica Stago, Inc.·Product code GGP·February 4, 2026

    Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device

    FDA Recall
    Open, Classified ·C.R. Bard Inc·Product code EZC·August 5, 2021

    Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device

    FDA Recall
    Open, Classified ·C.R. Bard Inc·Product code MJC·August 5, 2021

    Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device

    FDA Recall
    Open, Classified ·C.R. Bard Inc·Product code EZC·August 5, 2021