CLASS II ONGOING Device recall · Reported 29 Jan 2025 · FDA Enforcement Report
Halyard Laparotomy Pack recalled by O&m Halyard
O&M Halyard is recalling Halyard Laparotomy Pack, distributed nationwide in the US. The recall was initiated on 26 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0983-2025
- FDA event ID
- 95920
- Recalling firm
- O&M Halyard, Mechanicsville, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Nov 2024
- FDA classified
- 17 Jan 2025
- Reported
- 29 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Medical Software
Timeline
| 26 Nov 2024 | Recall initiated by company | |
| 17 Jan 2025 | Classified by FDA | +52 days |
| 29 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
Where it was distributed
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.
Nationwide ColoradoFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasLouisianaMichiganMinnesotaMissouriNorth CarolinaNebraskaNew YorkTennesseeTexasVirginiaWisconsin
Questions about this recall
Why was it recalled?
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Which lots are affected?
Model No 88231; UDI-DI: 30680651882319; Lot Number: AC2335502D; Exp Date 21-12-28
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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