FDA Medical devices recall ·
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack… recall
- Recall number
- Z-2520-2025
- Date
- (initiated July 17, 2025)
- Company / brand
- O&M Halyard, Inc.
1220 Old Alpharetta Rd Ste 320, Alpharetta, GA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1316
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Why was it recalled?
Surgical drape packs may have open seals, which may compromise the sterility of the product.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model/UDI-DI/Lot(expiration): 88041-12/30680651880414/AC2424601B9(09/02/2029), 77165-06/30680651771651/AC2424902B(09/05/2029)
Distribution
Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX.
States: Alabama Georgia Pennsylvania
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2520-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.