Class IIOngoingZ-2969-2026
Gentherm Medical, LLC recalls Innercool Coolblue Console
Overheating of the 115V CPU board may cause the device to shut down.
Gentherm Medical, LLCOHAug 26, 2026
2026 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 133–144 of 2,088 recalls
Class IIOngoingZ-2968-2026
Gentherm Medical, LLC recalls Blanketrol II Model 222S
Overheating of the 115V CPU board may cause the device to shut down.
Gentherm Medical, LLCOHAug 26, 2026
Class IIOngoingZ-2967-2026
Paragonix Technologies Inc. recalls Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-800…
Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.
Paragonix Technologies…MAAug 26, 2026
Class IIOngoingZ-2966-2026
Siemens Healthcare Diagnostics Products Ltd. recalls Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Siemens Healthcare Dia…Aug 26, 2026
Class IIOngoingZ-2965-2026
Siemens Healthcare Diagnostics Products Ltd. recalls Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981…
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Siemens Healthcare Dia…Aug 26, 2026
Class IIOngoingZ-2964-2026
AVID Medical, Inc. recalls Halyard LAVH PACK
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
AVID Medical, Inc.VAAug 26, 2026
Class IIOngoingZ-2963-2026
Maquet Critical Care AB recalls GETINGE Y SENSOR Module
The module did not undergo electrical safety tests and functional tests during production.
Maquet Critical Care A…Aug 26, 2026
Class IIOngoingZ-2962-2026
Boston Scientific Corporation recalls Suture Cinch Long 1pk. Endoscopic tissue approximation device.
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Boston Scientific Corp…MAAug 26, 2026
Class IIOngoingZ-2961-2026
Boston Scientific Corporation recalls OverStitch Suture Cinch
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Boston Scientific Corp…MAAug 26, 2026
Class IIOngoingZ-2960-2026
Tobii Dynavox LLC recalls TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit.…
Tobii Dynavox LlcPAAug 26, 2026
Class IIOngoingZ-2959-2026
Tobii Dynavox LLC recalls TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit.…
Tobii Dynavox LlcPAAug 26, 2026
Class IIOngoingZ-2958-2026
Arrowhead DE LLC recalls Arrow-LOK Implant
Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
Arrowhead DE LLCGAAug 26, 2026