BEUDAMED
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    Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

    FDA Recall
    Completed ·Bio-Rad Labs·Product code MVM·April 3, 2019

    Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD; 2. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & Mask, REF # 2442-BVMPCH; 3. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, Infant and Neonate Mask, REF # 2442-BVMCIN; 4. Curaplex Infant Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & 2 Masks, REF # 2442-BVMPIN; 5. Curaplex Small Adult Pediatric Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, PEEP Valve and 2 Masks, REF # 2442-BVMPSA.

    FDA Recall
    Open, Classified ·SunMed Holdings, LLC·Product code BTM·October 11, 2023

    BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.

    FDA Recall
    Terminated ·Verathon, Inc.·Product code IYO·August 23, 2010

    Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code FJK·November 19, 2010

    Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code FJK·November 19, 2010

    TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code KGG·October 11, 2013

    VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.

    FDA Recall
    Terminated ·MEDLINE INDUSTRIES, LP Northfield·Product code OFF·September 1, 2022

    MIM software; System, Image Processing, Radiological

    FDA Recall
    Open, Classified ·MIM Software Inc·Product code LLZ·February 19, 2025

    TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code KGG·October 11, 2013

    Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code ONW·August 29, 2013

    SpeedPass Disposable Suture Lariat with Nitinol Wire 45 Degree Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904008. Used to pass suture through tissue.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code MDM·June 18, 2010

    Stryker 9 MM AVS TL Trial Spacer; Catalog number: 48389409. Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401. Intended for use in the thoraco-lumbar spine.

    FDA Recall
    Terminated ·Stryker Spine·Product code MDM·May 13, 2010

    FlexTrayTM Endopath Bariatric Tray, Kit Code TBW70S.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code MDM·December 15, 2004

    Endopath 5 mm Babcocks with Ratchet Handles (product code 5BB).

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code MDM·December 15, 2004

    FlexTrayTM Endopath Cholecsystectomy Tray, Kit Code TNC06.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code MDM·December 15, 2004

    FlexTrayTM Endopath Cholecsystectomy Tray, Kit code FDC21

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code MDM·December 15, 2004

    Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples with integral knife, Product No. TCT10, staple size: 3 mm x 4.5 mm.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code MDM·May 21, 2003

    Proximate Linear Cutter with Safety Lock-Out, reloadable, contains 100 titanium staples with integral knife, Product No. #TLC10, staple size: 3 mm x 3.85 mm.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code MDM·May 21, 2003

    Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes

    FDA Recall
    Terminated ·Cochlear Americas Inc.·Product code MCM·June 5, 2015

    AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.

    FDA Recall
    Terminated ·Advanced Bionics, LLC·Product code MCM·February 17, 2020