Complete FDA and NHTSA recall records dated in 2022, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display…
Product is mislabeled as self-righting Luer slip tip caps, yellow.
Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization…
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display…
Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone…
Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S. market because use may lead to inaccurate test results, including false negative or false…
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display…
False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target…
Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are…
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display…
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display…
IRISpec CA failures for glucose.
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display…
Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone…
Evaporation of stabilizing liquid reducing shelf life.
Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are…
Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.
Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth…
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display…
During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall,…
In instances where custom reference ranges were configured on the device post installation, a possibility to inadvertently apply changes to reference range values was found on software…
False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target…
Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth…
Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are…
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.
