Exact FDA event identifier

Event 95920

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: November 26, 2024
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: O&M HALYARD, INC.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A

Z-0983-2025

Recall number: Z-0983-2025
Initiated: November 26, 2024
Classification: Class II
Status: Ongoing
Recalling firm: O&M HALYARD, INC.
Quantity: 1440 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.

Code information

Model No 88231; UDI-DI: 30680651882319; Lot Number: AC2335502D; Exp Date 21-12-28

Distribution pattern

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.