Recall Z-2520-2025— O&M HALYARD INC

Name: FDA recall Z-2520-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-17

Class II · Ongoing

Class II FDA medical device recall by O&M HALYARD INC, initiated 2025-07-17. It names one FDA 510(k) clearance: K083234. Product: Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029. Reason: Surgical drape packs may have open seals, which may compromise the sterility of the product..

Recalling firm: O&M HALYARD INC
Classification: Class II
Status: Ongoing
Initiated: 2025-07-17
Firm location: Alpharetta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K083234 — KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100Kimberly-Clark Corp.·cleared 2009-03-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.