Class IOngoingZ-1470-2026
Abiomed, Inc. recalls Impella RP Flex with SmartAssist. Product Code: 1000323.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Abiomed, Inc.MAMar 11, 2026
Class I recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 181–192 of 595 recalls
Class IOngoingZ-1469-2026
Abiomed, Inc. recalls Impella RP with SmartAssist. Product Code: 0046-0035.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Abiomed, Inc.MAMar 11, 2026
Class IOngoingZ-1354-2026
Olympus Corporation Of The Americas recalls Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of…
Issue with software algorithm which may lead to overpressure events.
Olympus Corporation of…PAFeb 25, 2026
Class IOngoingZ-1353-2026
Olympus Corporation Of The Americas recalls Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of…
Issue with software algorithm which may lead to overpressure events.
Olympus Corporation of…PAFeb 25, 2026
Class IOngoingZ-1352-2026
Olympus Corporation Of The Americas recalls Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of th…
Issue with software algorithm which may lead to overpressure events.
Olympus Corporation of…PAFeb 25, 2026
Class IOngoingZ-1325-2026
Medline Industries, LP recalls Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ult…
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reac…
Medline Industries, LPILFeb 18, 2026
Class IOngoingZ-1324-2026
Medline Industries, LP recalls Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense…
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reac…
Medline Industries, LPILFeb 18, 2026
Class IOngoingZ-1323-2026
Medline Industries, LP recalls Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter…
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reac…
Medline Industries, LPILFeb 18, 2026
Class IOngoingZ-1322-2026
Medline Industries, LP recalls Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St…
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reac…
Medline Industries, LPILFeb 18, 2026
Class IOngoingZ-1321-2026
Medline Industries, LP recalls Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Stee…
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reac…
Medline Industries, LPILFeb 18, 2026
Class IOngoingZ-1320-2026
Medline Industries, LP recalls Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerabl…
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reac…
Medline Industries, LPILFeb 18, 2026
Class IOngoingZ-1319-2026
Medline Industries, LP recalls Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes…
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reac…
Medline Industries, LPILFeb 18, 2026