Class IOngoingZ-2482-2025
Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheter Malleable body and vented connector
The catheters may not retain their shape.
Medtronic Perfusion Sy…MNSep 10, 2025
Recalls: Process change control
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 97–108 of 185 recalls
Class IOngoingZ-2481-2025
Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheter Malleable body and vented connector
The catheters may not retain their shape.
Medtronic Perfusion Sy…MNSep 10, 2025
Class IOngoingZ-2480-2025
Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheter Malleable body and vented connector
The catheters may not retain their shape.
Medtronic Perfusion Sy…MNSep 10, 2025
Class IIOngoingZ-2461-2025
Medtronic Xomed, Inc. recalls IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC P…
Due to out of the box wobble of the driver.
Medtronic Xomed, Inc.FLSep 3, 2025
Class IOngoingZ-2273-2025
Boston Scientific Corporation recalls Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent
Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidew…
Boston Scientific Corp…MNAug 20, 2025
Class IIOngoingZ-2222-2025
Osteotec Limited recalls Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Num…
There is the potential that the silicone implant may contain foreign material
Osteotec LimitedAug 6, 2025
Class IIOngoingZ-2192-2025
Phasor Health, LLC recalls Phasor Drill
Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.
Phasor Health, LLCTXAug 6, 2025
Class IIOngoingZ-2174-2025
HeartSine Technologies Ltd recalls HeartSine SAM 350P
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
HeartSine Technologies…Aug 6, 2025
Class IIOngoingZ-2119-2025
Waismed Ltd. recalls Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 10…
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Waismed Ltd.Jul 23, 2025
Class IIOngoingZ-2118-2025
Waismed Ltd. recalls Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 1…
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Waismed Ltd.Jul 23, 2025
Class IIOngoingZ-2099-2025
Canary Medical, Inc. recalls Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number:…
Due to labeling error. Product incorrectly labeled.
Canary Medical, Inc.CAJul 16, 2025
Class IOngoingZ-1961-2025
Integra LifeSciences Corp. (NeuroSciences) recalls MicroMyst Applicator
Lack of sterility assurance.
Integra LifeSciences C…NJJul 2, 2025