Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 925–936 of 2,088 recalls
Out-of-specification endotoxin result that did not meet the acceptance criteria.
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rot…
Product has the potential for false positive results
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Due to nonconforming products being inadvertently distributed.
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows.…
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows.…
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows.…
Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local b…