Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,213–1,224 of 3,866 recalls
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.
A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery.…
Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formu…
Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample…
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay t…
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay t…
Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use.…
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.