Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 625–636 of 3,866 recalls
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.
Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications.…
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Lar…
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Lar…
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Lar…
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured