Complete FDA and NHTSA recall records dated in 2025, 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.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose a…
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red…
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error…
Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left…
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in…
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Out of specification stability test result for the Caphosol B solution from process validation lots
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in…
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software…
GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous…
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.
