Exact FDA event identifier

Event 81555

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

Open FDA event record

Event summary

Timeline bucket: October 16, 2018
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: ASO, LLC

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

Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box

Z-0525-2019

Recall number: Z-0525-2019
Initiated: October 16, 2018
Classification: Class II
Status: Ongoing
Recalling firm: ASO, LLC
Quantity: 218 cases (72, 10-ct boxes per case)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential that gauze pads may not be fully sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential that gauze pads may not be fully sterilized

Code information

ASO Item No. 780655, Batch/Lot # 2384-20180524

Distribution pattern

Distributed nationwide to AR, FL, IA, IN, KY, NY, OK, TX, UT, VA.