Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
21,924 detailed records are currently available in this category.
Out of specification stability test result for the Caphosol B solution from process validation lots
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
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…
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.
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…
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…
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
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…
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
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…
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.
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.
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values…
Lack of sterility assurance.
Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.
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…
Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more affected units can lead to systems not functioning reliably:audio, video…
Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in…
Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
