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

FDA device recall Z-2520-2025 · posted 2025-09-04 · Open, Classified

Recall details

Recalling firm: O&M HALYARD INC
Reason for recall: Surgical drape packs may have open seals, which may compromise the sterility of the product.
Action taken: On 7/17/2025, Field Action Customer Notifications were emailed to customers who were asked to do the following: 1) DESTROY or DISCARD the product available in your inventory per the facility's standard disposal procedure for surgical packs. 2) COMMUNICATE this Field Action to staff to ensure awareness of it. 3) If any of the affected lot identified above was further distributed, please ensure all end-users are appropriately notified of this Field Action and maintain records of effectiveness. 4) Any adverse events associated with the use of the affected product should be reported to complaints@owens-minor.com. 5) RETURN the completed Field Action Response Form to GM-OMRA_RECALLS@owens-minor.com as soon as possible even if you have no current product inventory. 6) If credit is requested, please get contact with the Customer Service team and send email to GM-OMRA_RECALLS@owens-minor.com. If you have any questions, please email GM-OMRA_RECALLS@owens-minor.com using the Event # FA-2025-015 in the header of the response
Root cause: Process control
Status: Open, Classified
Product code: KKX
Quantity affected: 1316
Distribution: Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX.
Date initiated: 2025-07-17
Date posted: 2025-09-04
Location: Alpharetta, GA

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 (K083234)	Kimberly-Clark Corp.	2009-03-25