Class IIOngoingZ-1762-2025
Cook Incorporated recalls Tornado Embolization Microcoil
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
Cook IncorporatedINMay 21, 2025
2025 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,861–1,872 of 2,908 recalls
Class IIOngoingZ-1761-2025
Augmedics Ltd. recalls Augmedics Perc Pin Adaptor
The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.
Augmedics Ltd.May 21, 2025
Class IITerminatedZ-1754-2025
Numed Inc recalls BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
Numed IncNYMay 21, 2025
Class IIOngoingZ-1753-2025
Richard Wolf GmbH recalls PiezoWave 2 Control Unit
The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell.…
Richard Wolf GmbHMay 21, 2025
Class IIOngoingZ-1752-2025
LeMaitre Vascular, Inc. recalls Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
LeMaitre Vascular, Inc…MAMay 21, 2025
Class IIOngoingZ-1751-2025
LeMaitre Vascular, Inc. recalls Pruitt Occlusion Catheter. Catalog Numbers: 2103-36
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
LeMaitre Vascular, Inc…MAMay 21, 2025
Class IIOngoingZ-1750-2025
LeMaitre Vascular, Inc. recalls TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
LeMaitre Vascular, Inc…MAMay 21, 2025
Class IIOngoingZ-1749-2025
Abbott Molecular, Inc. recalls Alinity m Resp-4-Plex AMP Kit
There were reports of an increase in reactive negative controls and false positive results.
Abbott Molecular, Inc.ILMay 21, 2025
Class IIOngoingZ-1748-2025
Abbott Molecular, Inc. recalls Alinity m Resp-4-Plex Amplification (AMP) Kit (CE)
There were reports of an increase in reactive negative controls and false positive results.
Abbott Molecular, Inc.ILMay 21, 2025
Class IIOngoingZ-1747-2025
Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)
Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim.…
- Somatic Or Germline Variant Detection System Next Generation Sequencing Oncology Panel
- Under Investigation by firm
Foundation Medicine, I…MAMay 21, 2025
Class IIOngoingZ-1745-2025
Meddev Corp recalls Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL…
Due to mislabeling of products
Meddev CorpCAMay 21, 2025
Class IIOngoingZ-1744-2025
Meddev Corp recalls Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL…
Due to mislabeling of products
Meddev CorpCAMay 21, 2025