50 results
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24ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DTZ·December 12, 2022
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
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
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DTZ·December 12, 2022
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DTZ·December 12, 2022
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DTZ·December 12, 2022
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DTZ·December 12, 2022
HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
FDA Recall
Open, Classified
·The Magstim Company Limited Spring Gardens Whitland United Kingdom·Product code OBP·October 25, 2018
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE
FDA Recall
Open, Classified
·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code JKA·April 8, 2022
NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E
FDA Recall
Open, Classified
·Product code BYS·October 11, 2023
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E
FDA Recall
Open, Classified
·Product code BYS·October 11, 2023
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 L; Prepared with Balanced Heparin Model/Catalog Number: 06 0185 Product Description: A clear, plastic capillary blood collection tube
FDA Recall
Open, Classified
·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·Product code GIO·September 26, 2025
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187 Product Description: A clear, plastic capillary blood collection tube
FDA Recall
Open, Classified
·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·Product code GIO·September 26, 2025
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
FDA Recall
Open, Classified
·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·Product code GIO·September 26, 2025
iBOT PMD with software version 01.05.24. Personal Mobility Device.
FDA Recall
Open, Classified
·Mobius Mobility LLC·Product code IMK·April 24, 2025
Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.
FDA Recall
Open, Classified
·WANDERCRAFT SAS·Product code PHL·April 3, 2025
UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display, store data needed for planning a spine surgery or for post-operative follow-up (patient information, X-ray image and recommendations for planning). The UNiD Spine Analyzer cloud based software is a healthcare application intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries.
FDA Recall
Open, Classified
·Product code LLZ·December 3, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management System Kit, REF BRC-BAL-INT-SL/B An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code NWU·June 11, 2024
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
FDA Recall
Open, Classified
·Fresenius Kabi USA, LLC·Product code FRN·November 3, 2025
Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a treadmill. The device will be used as an assistive device for gait deficiency rehabilitation and research purposes.
FDA Recall
Open, Classified
·MOTEK MEDICAL B.V. Hogehilweg 18 18 Unit C Amsterdam Netherlands·Product code BXB·July 29, 2019