Avanos Medical, Inc.

9 FDA enforcement actions

9 Total Recalls

8 Class I

1 Class II

0 Class III

Firm Details

Product Types: device
States: GA

All Recalls

Class I: Dangerous 03/19/2025 device

Lack of sterility assurance for closed suction catheter systems
Class I: Dangerous 03/19/2025 device

Lack of sterility assurance for closed suction catheter systems
Class I: Dangerous 03/19/2025 device

Lack of sterility assurance for closed suction catheter systems
Class I: Dangerous 03/19/2025 device

Lack of sterility assurance for closed suction catheter systems
Class I: Dangerous 03/19/2025 device

Lack of sterility assurance for closed suction catheter systems
Class I: Dangerous 03/19/2025 device

Lack of sterility assurance for closed suction catheter systems
Class I: Dangerous 03/19/2025 device

Lack of sterility assurance for closed suction catheter systems
Class I: Dangerous 03/19/2025 device

Lack of sterility assurance for closed suction catheter systems
Class II: Risk 05/31/2024 device

The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.