FDA Medical Device Recalls (openFDA)
ASO, LLC: 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
- Recall number
- Z-0525-2019
- Recalling firm
- ASO, LLC
- 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
- Status
- Open, Classified
- Initiated
- 2018-10-16
- Posted
- not on file
- Terminated
- not on file
- Reason
- Potential that gauze pads may not be fully sterilized
- Root cause
- Under Investigation by firm
- Action
- ASO, LLC notified customers of the recall on about 10/16/2018 via "URGENT: MEDICAL DEVICE RECALL" letter sent to corporate. Instructions were to immediately stop using/distributing the affected gauze pads, place them in quarantine, and return to ASO LLC. Customers were also instructed to complete and return the response form.
- Quantity
- 218 cases (72, 10-ct boxes per case)
- Distribution
- Distributed nationwide to AR, FL, IA, IN, KY, NY, OK, TX, UT, VA.
- Lot, serial or model codes
- ASO Item No. 780655, Batch/Lot # 2384-20180524
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NAB
- Firm FEI
- 1038758
- Firm city
- Sarasota
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28