BEUDAMED
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    Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF 30-202 Model Number: 1001 UDI-DI code: 07350137520593 Reamer Adapter OTD REF 30-157 Model Number: 1003 UDI-DI code: 07350137520081 Inserter Adapter OTD REF 30-158 Model Number: 1004 UDI-DI code: 07350137520098 The Inserter Adapters are intended to be attached to a Cup Inserter Tool. The Cup Inserter Tool (impactor) is intended to be tracked by and navigated to orient and position the hip implant cup correctly relative to preoperative planned position and orientation.

    FDA Recall
    Open, Classified ·ORTOMA AB Falkenbergsgatan 3 Goteborg Sweden·Product code OLO·July 28, 2025

    Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision physician or other certified healthcare professional.

    FDA Recall
    Open, Classified ·Zyno Medical LLC·Product code FRN·September 30, 2024

    Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    FDA Recall
    Open, Classified ·Oto Med Inc·Product code MXP·December 7, 2020

    Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    FDA Recall
    Open, Classified ·Oto Med Inc·Product code MXP·December 7, 2020

    Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    FDA Recall
    Open, Classified ·Oto Med Inc·Product code MXP·December 7, 2020

    Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)

    FDA Recall
    Open, Classified ·CUE HEALTH INC·Product code QWB·May 24, 2024

    Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by suture/collagen-based hemostatic devices.

    FDA Recall
    Open, Classified ·TELEFLEX LLC·Product code MGB·April 12, 2023

    DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F 8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F Note: PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC).

    FDA Recall
    Open, Classified ·Carestream Health, Inc.·Product code KPR·January 30, 2023

    Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DTZ·September 12, 2025

    CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC

    FDA Recall
    Open, Classified ·Terumo Cardiovascular Systems Corporation·Product code DTZ·March 1, 2023

    QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

    QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

    BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

    Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000

    FDA Recall
    Open, Classified ·GETINGE US SALES LLC·Product code DTZ·November 13, 2019

    BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025

    FDA Recall
    Open, Classified ·Cypress Medical Products LLC·Product code GTZ·August 20, 2024

    QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

    Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DTZ·December 12, 2022

    BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·July 22, 2022

    QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-USA 701067938 Small Adult with filter, with SOFTLINE Coating HMO 70100-USA 701067874 Adult without filter, with SOFTLINE Coating HMO 71100-USA 701067886 Adult with filter, with SOFTLINE Coating

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023