FDA Medical Device Recalls (openFDA)
O&M HALYARD INC: Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
- Recall number
- Z-2520-2025
- Recalling firm
- O&M HALYARD INC
- Product
- Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
- Status
- Open, Classified
- Initiated
- 2025-07-17
- Posted
- 2025-09-04
- Terminated
- not on file
- Reason
- Surgical drape packs may have open seals, which may compromise the sterility of the product.
- Root cause
- Process control
- Action
- 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
- Quantity
- 1316
- Distribution
- Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX.
- Lot, serial or model codes
- Model/UDI-DI/Lot(expiration): 88041-12/30680651880414/AC2424601B9(09/02/2029), 77165-06/30680651771651/AC2424902B(09/05/2029)
- 510(k) numbers
- ["K083234"]
- PMA numbers
- not on file
- Product code
- KKX
- Firm FEI
- 3014421917
- Firm city
- Alpharetta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28