Medical device recalls Moderate risk

O&M HALYARD INC recalls Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029

Recall date
July 17, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2520-2025
FDA classification
Class II
Brand / firm
O&M HALYARD INC
Sold / distributed
Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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