BEUDAMED
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    STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].

    FDA Recall
    Open, Classified ·Ethicon, Inc. Us·Product code GAM·March 24, 2022

    Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control

    FDA Recall
    Open, Classified ·Microgenics Corporation·Product code JJY·October 1, 2025

    NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload.

    FDA Recall
    Open, Classified ·NxStage MDS Corporation·Product code KDI·January 29, 2024

    STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12

    FDA Recall
    Open, Classified ·Ethicon, Inc. Us·Product code GAM·September 20, 2022

    PDS Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H

    FDA Recall
    Open, Classified ·Ethicon, Inc.·Product code NEW·March 31, 2023

    MICRO-X Rover Mobile X-ray System, # MXU-RV35

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·May 31, 2023

    MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·November 28, 2023

    The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code IZL·November 23, 2023

    MICRO-X Rover Mobile X-ray System, # MXU-RV19

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·October 23, 2024

    Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN:10995489

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code NIG·July 26, 2024

    ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491244

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code NIG·July 26, 2024

    Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 11206239

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code NIG·July 26, 2024

    Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10995490

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code NIG·July 26, 2024

    ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491379 SMN: 11206239

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code NIG·July 26, 2024

    ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.

    FDA Recall
    Open, Classified ·MEDTECH SAS 900 Rue Du Mas De Verchant Montpellier France·Product code HAW·September 22, 2021

    Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW GS3 OUS/GTIN: 20763000358451 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

    FDA Recall
    Open, Classified ·Medtronic Inc.·Product code MDS·February 26, 2021

    Vaginal Delivery, ASDV25B; Medical convenience kit

    FDA Recall
    Open, Classified ·American Contract Systems, Inc.·Product code MLS·August 7, 2024

    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.

    FDA Recall
    Open, Classified ·American Contract Systems Inc·Product code MLS·July 14, 2025

    LABOR & DELIVERY PACK, Model Nos LLLD19H

    FDA Recall
    Open, Classified ·American Contract Systems Inc·Product code MLS·February 6, 2025

    BORN ON ARRIVAL KIT , Model No LLBN11B

    FDA Recall
    Open, Classified ·American Contract Systems Inc·Product code MLS·February 6, 2025