BEUDAMED
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    Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table

    FDA Recall
    Open, Classified ·Oakworks Inc·Product code LGX·December 5, 2023

    Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table

    FDA Recall
    Open, Classified ·Oakworks Inc·Product code LGX·December 5, 2023

    Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table

    FDA Recall
    Open, Classified ·Oakworks Inc·Product code LGX·December 5, 2023

    Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left & right}

    FDA Recall
    Open, Classified ·Oakworks Inc·Product code LGX·December 5, 2023

    Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectious Disease Immunoassay Strep A Test Throat / Tonsil Saliva Sample 25 Tests, Model Number: 5003. b. QUIDEL Sofia TEST KIT, STREP A+ SOFIA (25/KT 12KT/CS) Model Number: 20274. c. Alere SAN DIEGO INC McKesson TEST, KIT STREP A DIPSTICK WAIVED (50/KT) Exempt Catalog #4999. d. In-Line Control Swab Quickvue In-Line Strep A Test Positive Level / Negative Level 12 Swabs (IVD) Catalog # 00345. e. (added 11/30/22) Abbott Rapid Test Kit Acceava Infectious Disease Immunoassay Strep A Test Throat Swab Sample 50 Tests, Model Number: 92001

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

    Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID

    FDA Recall
    Open, Classified ·Nova Ortho-Med Inc·Product code ITJ·August 26, 2024

    Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID

    FDA Recall
    Open, Classified ·Nova Ortho-Med Inc·Product code ITJ·August 26, 2024

    Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID

    FDA Recall
    Open, Classified ·Nova Ortho-Med Inc·Product code ITJ·August 26, 2024

    Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD

    FDA Recall
    Open, Classified ·Ventana Medical Systems, Inc.·Product code NJT·June 27, 2024

    UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to short-term duration, especially in ophthalmology Art.no. / REF no.: 15000004 Art.no. / REF no.: 15000006

    FDA Recall
    Open, Classified ·UFSK International OSYS Gmbh Kirchhoffstr. 1 Ratisbon Germany·Product code HME·May 31, 2023

    Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code JHX·March 31, 2025

    YSIO X.Pree

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code KPR·March 7, 2022

    epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code JGS·July 7, 2025

    Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code PHX·August 15, 2025

    Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code PHX·August 15, 2025

    syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·February 25, 2022

    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·September 24, 2024

    GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A).

    FDA Recall
    Open, Classified ·Agilent Technologies, Inc.·Product code PFX·March 20, 2025

    COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.

    FDA Recall
    Open, Classified ·Copan Diagnostics Inc·Product code JRC·July 14, 2023

    BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1-PRT-0251

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PEN·October 17, 2023