O&M HALYARD INC

4 FDA enforcement actions

4 Total Recalls

0 Class I

4 Class II

0 Class III

Firm Details

Product Types: device
States: GA, VA

All Recalls

Class II: Risk 07/17/2025 device

Surgical drape packs may have open seals, which may compromise the sterility of the product.
Class II: Risk 11/26/2024 device

Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Class II: Risk 11/08/2024 device

Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.
Class II: Risk 11/08/2024 device

Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.

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.