FDA Medical Device Recalls (openFDA)
O&M HALYARD, INC.: Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
- Recall number
- Z-0983-2025
- Recalling firm
- O&M HALYARD, INC.
- Product
- Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
- Status
- Open, Classified
- Initiated
- 2024-11-26
- Posted
- 2025-01-17
- Terminated
- not on file
- Reason
- Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
- Root cause
- Process control
- Action
- On November 26, 2024 URGENT VOLUNTARY RECALL letters were emailed to consignees. ACTIONS TO TAKE: " Immediately discontinue use of the Laparotomy Pack identified in APPENDIX 1. Please review your inventory, and segregate and quarantine all affected Packs. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. " Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. " Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. " 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. ADDITIONAL INFORMATION: Report any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com. Your assistance is appreciated and necessary to prevent any risk to patient health as a result of not following the field correction instructions. If you have any questions, please email GM-OMRA_RECALLS@owens-minor.com using the Event # FA-2024-031 in the header of the response. This will ensure prompt response by the O&M Halyard, Inc, team.
- Quantity
- 1440 units
- Distribution
- US Nationwide distribution in the states of CO, FL, GA, HI, IA, IL, IN, KS, LA, MI, MN, MO, NC, NE, NY, TN, TX, VA, WI.
- Lot, serial or model codes
- Model No 88231; UDI-DI: 30680651882319; Lot Number: AC2335502D; Exp Date 21-12-28
- 510(k) numbers
- ["K083234"]
- PMA numbers
- not on file
- Product code
- KKX
- Firm FEI
- 3014527898
- Firm city
- Mechanicsville
- Firm state
- VA
- 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