Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Summary
The FDA issued a Class II for Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: by O&M HALYARD INC. Reason: Surgical drape packs may have open seals, which may compromise the sterility of the product..
Details
Source
Device Recall
External ID
Z-2520-2025
Action Date
2025-09-10
Status
Ongoing
Category
device
Product Description
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Lot/Code Info: Model/UDI-DI/Lot(expiration): 88041-12/30680651880414/AC2424601B9(09/02/2029), 77165-06/30680651771651/AC2424902B(09/05/2029)
Quantity Affected: 1316
Reason for Recall
Surgical drape packs may have open seals, which may compromise the sterility of the product.
Distribution
Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-17
Company
Alpharetta, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 258 device recalls issued in the same week, part of 403 device-related FDA actions this month.
O&M HALYARD INC has 24 FDA actions in our database, including 8 recalls and 16 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (O&M HALYARD INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does O&M HALYARD INC have FDA actions?
O&M HALYARD INC has 24 FDA actions in our database, including 8 recalls and 16 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2520-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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