Class IOngoingZ-2977-2026
Boston Scientific Corporation recalls Boston Scientific ENROUTE Transcarotid Neuroprotection System
Potential for arterial sheath tip separation or partial tip separation during use.
Boston Scientific Corp…MNAug 26, 2026
Ongoing recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 61–72 of 4,896 recalls
Class IIOngoingZ-2976-2026
Siemens Healthcare Diagnostics, Inc. recalls Beckman Coulter
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, includi…
Siemens Healthcare Dia…MAAug 26, 2026
Class IIOngoingZ-2975-2026
Siemens Healthcare Diagnostics, Inc. recalls Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, includi…
Siemens Healthcare Dia…MAAug 26, 2026
Class IIOngoingZ-2974-2026
Beckman Coulter Inc. recalls Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lowe…
a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version.…
Beckman Coulter Inc.CAAug 26, 2026
Class IIOngoingZ-2973-2026
Beckman Coulter Inc. recalls Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower:…
a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version.…
Beckman Coulter Inc.CAAug 26, 2026
Class IIIOngoingZ-2972-2026
Paragon 28, Inc. recalls Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Paragon 28, Inc.COAug 26, 2026
Class IIIOngoingZ-2971-2026
Paragon 28, Inc. recalls Custom Made Device Implant 6123 Navicular Cage Small Right Rev A
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Paragon 28, Inc.COAug 26, 2026
Class IIOngoingZ-2970-2026
Gentherm Medical, LLC recalls Blanketrol III
Overheating of the 115V CPU board may cause the device to shut down.
Gentherm Medical, LLCOHAug 26, 2026
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
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