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.
24,239 detailed records are currently available in this category.
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate…
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate…
Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There is also a potential for Easy Read App to be unable to reads the test results…
Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate…
There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.
If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire…
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate…
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate…
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified…
Gauge malfunction: Digital gauge displays an incorrect tank pressure - displays pressure higher than actual tank pressure. This may lead to tank running out of oxygen during use without…
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate…
If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire…
If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will…
If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will…
Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and…
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate…
Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.
Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation…
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate…
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified…
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate…
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.
