Data Foundry

Medical device recalls 2018

Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in — Class II medical device recall Z-0525-2019

Ongoing recall by ASO, LLC, reported 2018-12-12, distributed nationwide. Potential that gauze pads may not be fully sterilized

Recall numberZ-0525-2019
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmASO, LLC, Sarasota, FL, United States
Recall initiated2018-10-16
Classified2018-11-30
Reported by FDA2018-12-12
DistributedNationwide (US)
Lot numbers2384-20180524
Model numbers780655

Product

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

Reason for recall

Potential that gauze pads may not be fully sterilized

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0525-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.