O&M HALYARD INC: Device Recall

Recall #Z-2520-2025 · 07/17/2025

Class II: Risk

Recall Details

Recall Number: Z-2520-2025
Classification: Class II
Product Type: Device
Recalling Firm: O&M HALYARD INC
Status: Ongoing
Date Initiated: 07/17/2025
Location: Alpharetta, GA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1316

Reason for Recall

Surgical drape packs may have open seals, which may compromise the sterility of the product.

Product Description

Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029

Distribution Pattern

Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX.

Other Recalls by O&M HALYARD INC

Class II: Risk 11/26/2024

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

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

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.

View all recalls by O&M HALYARD INC →

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.