Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 73–84 of 4,932 recalls
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
The module did not undergo electrical safety tests and functional tests during production.
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
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.…
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.…
Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
Device will intermittently provide inaccurate data related to native heart rate.
Device will intermittently provide inaccurate data related to native heart rate.
Potential for electrical discharge from unit when unplugged.