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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Halyard Orthopedic and Universal Surgical Drape Packs Recalled for Sterility Risk

Agency Publication Date: September 4, 2025
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Summary

O&M Halyard is recalling 1,316 surgical drape packs, including Orthopedic and Universal models, because the packaging seals may be open. This defect can compromise the sterility of the product, which is intended to be used in sterile surgical environments. Healthcare providers should immediately stop using the affected packs and contact the manufacturer to arrange for a return or replacement.

Risk

Open seals can allow bacteria or other contaminants to enter the drape pack, compromising sterility and increasing the risk of surgical site infections for patients.

What You Should Do

  1. This recall affects Halyard Orthopedic Pack (model 88041-12) and Universal Pack (model 77165-06) used in surgical settings.
  2. Check your surgical inventory for Orthopedic Pack lot AC2424601B9 (Expiration 09/02/2029) and Universal Pack lot AC2424902B (Expiration 09/05/2029).
  3. Stop using the recalled surgical drape packs immediately and quarantine them to prevent accidental use in medical procedures.
  4. Contact O&M Halyard Inc. or your medical supply distributor to arrange for the return, replacement, or correction of these products.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Orthopedic Pack
Model / REF:
88041-12
Lot Numbers:
AC2424601B9 (Exp 09/02/2029)
UDI:
30680651880414

Model and lot identified in the FDA enforcement data.

Product: Universal Pack
Model / REF:
77165-06
Lot Numbers:
AC2424902B (Exp 09/05/2029)
UDI:
30680651771651

Model and lot identified in the FDA enforcement data.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97394
Status: Active
Manufacturer: O&M HALYARD INC
Sold By: Medical supply distributors; Healthcare facilities
Manufactured In: United States
Units Affected: 1316
Distributed To: Georgia, Alabama, Pennsylvania

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.