Complete FDA and NHTSA recall records dated in March 2022.
These records include useful source details for the selected month.
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these…
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to…
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to…
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Sterility of device is compromised due to a sterile barrier breach
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Sterility of device is compromised due to a sterile barrier breach
Failed stability specifications for reagent kits that may result in false negative test results.
Sterility of device is compromised due to a sterile barrier breach
Sterility of device is compromised due to a sterile barrier breach
Sterility of device is compromised due to a sterile barrier breach
Sterility of device is compromised due to a sterile barrier breach
Sterility of device is compromised due to a sterile barrier breach
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these…
Sterility of device is compromised due to a sterile barrier breach
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these…
Sterility of device is compromised due to a sterile barrier breach
Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate installation. There is potential that the screws are unable to secure the traverse rail…
Sterility of device is compromised due to a sterile barrier breach
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these…
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
