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Recall Observatory FDA recall evidence

Device product

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

Z-2520-2025

July 17, 2025

Class II

Product summary

Firm
O&M HALYARD INC
Event
Event 97394
Status
Ongoing
Classification
Class II
Quantity
1316
Official record key
device-enforcement:Z-2520-2025

Official wording

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

Code information: Model/UDI-DI/Lot(expiration): 88041-12/30680651880414/AC2424601B9(09/02/2029), 77165-06/30680651771651/AC2424902B(09/05/2029)

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    seals, which may compromise the sterility