Use cautionMedical device recall · FDA · Published July 17, 2025
O&M HALYARD Orthopedic Pack Recall: Open Seals Risk Sterility Compromise
O&M HALYARD recalls two orthopedic surgical drape packs with potential open seals that could compromise sterility. Affected packs have specific model numbers and dates. Consumers should check their items and contact the company for details.
“O&M HALYARD Orthopedic Pack Recall: Open Seals Risk Sterility Compromise.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51780-o-m-halyard-orthopedic-pack-recall-open-seals-risk-sterility. Based on FDA recall #Z-2520-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2520-2025%22&limit=1).
O&M HALYARD INC recalled Orthopedic and Universal Pack surgical drape packs due to open seals that may compromise sterility, the FDA said on July 17, 2025. The company initiated the voluntary Class II recall.
Surgical drape packs may have open seals, which may compromise the sterility of the product.
Context
GovInfoNow's records show O&M HALYARD INC has 6 other recalls on record since 2021-09-27. Other recent recalls include Halyard Purezero Ultraviolet Nitrile Exam Gloves Recall (2026-04-13), HALYARD Laparotomy Pack Recall (2024-11-26), and O&M Halyard SOFT TOUCH II Surgical Mask recall (2024-11-08). Other recent recalls of similar products include AVID Medical Halyard Drape Pack Kit: Unsterilized Pouches Recalled (2026-04-30), AVID Medical Halyard Laparoscopy Pack Recall (2025-11-14), and Alcon Custom Pak Sterility Risk (2025-11-24).
How to tell if you have this one
Check for model numbers 88041-12 (with expiration 09/02/2029) or 77165-06 (with expiration 09/05/2029). The packs have specific UDI-DI/Lot numbers listed in the recall notice.
Brand
O&M HALYARD
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Model
Look for model numbers 88041-12 or 77165-06 on the pack with the corresponding expiration dates.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Georgia, Pennsylvania.
Recall timeline
FDA published this recall 55 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2520-2025 (July 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2520-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.