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.
24,725 detailed records are currently available in this category.
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
Specific lots may have been manufactured with insufficient or incomplete welds.
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time and eventually detach from the baseplate, result in the display interface dismounting from…
Specific lots may have been manufactured with insufficient or incomplete welds.
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
Specific lots may have been manufactured with insufficient or incomplete welds.
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Specific lots may have been manufactured with insufficient or incomplete welds.
Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.
Specific lots may have been manufactured with insufficient or incomplete welds.
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
Potential that a limited number of individual contact lens packages have an incomplete packaging seal.
Specific lots may have been manufactured with insufficient or incomplete welds.
The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers.
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.
