BEUDAMED
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    Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable

    FDA Recall
    Open, Classified ·Draeger Medical, Inc.·Product code BSZ·October 15, 2024

    Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable

    FDA Recall
    Open, Classified ·Draeger Medical, Inc.·Product code BSZ·October 15, 2024

    Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Component: N/A

    FDA Recall
    Open, Classified ·Sterilmed, Inc.·Product code OWQ·October 8, 2025

    Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable

    FDA Recall
    Open, Classified ·Abbott Diagnostics Scarborough, Inc.·Product code OZE·February 9, 2026

    Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult Component: Not applicable

    FDA Recall
    Open, Classified ·Draeger, Inc.·Product code BZO·March 12, 2025

    QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214

    FDA Recall
    Open, Classified ·Qiagen GmbH Qiagen Str. 1 Hilden Germany·Product code QLT·May 19, 2023

    (1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training Purposes Only, Not For Human Use.; and (2) Nursing Tote Kit, SKU #EDUC5056A, Case UPC 40195327153695, Non-sterile, For Training Purposes Only, Not For Human Use.

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code NSB·October 16, 2023

    Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable

    FDA Recall
    Open, Classified ·Draeger, Inc.·Product code OFP·March 12, 2025

    Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable

    FDA Recall
    Open, Classified ·Draeger, Inc.·Product code OFP·March 12, 2025

    Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.

    FDA Recall
    Open, Classified ·Medartis AG Hochbergerstrasse 60e Basel Town Switzerland·Product code HWC·January 9, 2026

    Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult patients. The breathing circuit is intended for single use only. Component: Not applicable

    FDA Recall
    Open, Classified ·Draeger, Inc.·Product code CAI·March 12, 2025

    Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.

    FDA Recall
    Open, Classified ·Medartis AG Hochbergerstrasse 60e Basel Town Switzerland·Product code HWC·January 9, 2026

    Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable

    FDA Recall
    Open, Classified ·Draeger, Inc.·Product code OFP·March 12, 2025

    FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code OWD·July 20, 2022

    Brand Name: Solana Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains materials for 48 tests. One kit contains 48 tubes of 1.45 mL Process Buffer and 48 Reaction Tubes. Component: No, not a component

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code OZZ·March 24, 2025

    ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US

    FDA Recall
    Open, Classified ·Ethicon, LLC·Product code GAW·December 20, 2024

    therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code OWD·February 25, 2022

    therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code OWD·July 20, 2022

    Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO

    FDA Recall
    Open, Classified ·Neurovision Medical Products Inc·Product code ETN·July 1, 2024

    (1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human Use.

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·October 16, 2023