Complete FDA and NHTSA recall records dated in 2023, 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.
Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
Hyundai Motor America (Hyundai) is recalling certain 2021-2023 Palisade vehicles. The windshield wiper motor may operate intermittently or fail to operate due to snow or ice buildup on the…
Hyundai Motor America (Hyundai) is recalling certain 2019-2023 Santa Fe, 2021-2023 Santa Fe HEV, 2022-2023 Santa Fe Plug-in HEV and Santa Cruz vehicles potentially equipped with a tow hitch…
General Motors, LLC (GM) is recalling certain 2023 Cadillac XT6, GMC Acadia, Chevrolet Blazer, Traverse, and 2022-2023 Cadillac XT5 vehicles. The transmission may have been built with an…
Honda (American Honda Motor Co) is recalling certain 2020-2021 Pilot and Ridgeline, and 2020-2022 Passport and Odyssey vehicles. The heating pads behind both side-view mirrors may not be…
An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the…
Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000…
An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy…
An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the…
pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump…
Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000…
MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure…
pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000…
Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment.
Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an 8-month interval in 2022. For these…
New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein C 5 contains the chemical substance - Cesium Chloride which changed classification and has…
Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000…
Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and…
Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea…
Labeling being updated to assure user is securing the siderail to a locked position to prevent potential patient fall and injury.
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.
