Class IIOngoingZ-1375-2026
Olympus Corporation Of The Americas recalls Olympus Thunderbeat 5 mm
Firm is initiating a removal due to continued reports of adverse events.
Olympus Corporation of…PAFeb 25, 2026
Recalls in Pennsylvania
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 121–132 of 581 recalls
Class IIOngoingZ-1374-2026
Olympus Corporation Of The Americas recalls Olympus Thunderbeat
Firm is initiating a removal due to continued reports of adverse events.
Olympus Corporation of…PAFeb 25, 2026
Class IIOngoingZ-1373-2026
Olympus Corporation Of The Americas recalls Olympus Thunderbeat 5 mm
Firm is initiating a removal due to continued reports of adverse events.
Olympus Corporation of…PAFeb 25, 2026
Class IIOngoingZ-1372-2026
Olympus Corporation Of The Americas recalls Olympus Thunderbeat
Firm is initiating a removal due to continued reports of adverse events.
Olympus Corporation of…PAFeb 25, 2026
Class IIOngoingZ-1371-2026
Olympus Corporation Of The Americas recalls Olympus Thunderbeat 5 mm
Firm is initiating a removal due to continued reports of adverse events.
Olympus Corporation of…PAFeb 25, 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 IIOngoingZ-1307-2026
Fujirebio Diagnostics, Inc. recalls Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Softwar…
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, du…
Fujirebio Diagnostics,…PAFeb 11, 2026
Class IIOngoingZ-1306-2026
Fujirebio Diagnostics, Inc. recalls Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 23…
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, du…
Fujirebio Diagnostics,…PAFeb 11, 2026
Class IIOngoingZ-1305-2026
Fujirebio Diagnostics, Inc. recalls Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Cata…
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, du…
Fujirebio Diagnostics,…PAFeb 11, 2026
Class IIOngoingZ-1304-2026
Fujirebio Diagnostics, Inc. recalls Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software…
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, du…
Fujirebio Diagnostics,…PAFeb 11, 2026