FDA Medical devices recall ·
HALYARD Product Name: Laparotomy Pack Model recall
- Recall number
- Z-0983-2025
- Date
- (initiated November 26, 2024)
- Company / brand
- O&M Halyard, Inc.
9120 Lockwood Blvd, Mechanicsville, VA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1440 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
Why was it recalled?
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
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 No 88231; UDI-DI: 30680651882319; Lot Number: AC2335502D; Exp Date 21-12-28
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.
States: Colorado Florida Georgia Hawaii Iowa Illinois Indiana Kansas Louisiana Michigan Minnesota Missouri North Carolina Nebraska New York Tennessee Texas Virginia Wisconsin
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-0983-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.