Stryker Corporation recalls Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The Flu…
Due to nonconforming products being inadvertently distributed.
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 37–48 of 439 recalls
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.…
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses…
The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.