Food, drugs, devices › ASO, LLC
Device recall: Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauz
FDA enforcement event 81555 is a device recall by ASO, LLC of Sarasota, FL, initiated 16 Oct 2018 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. ASO, LLC has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
ASO, LLC, Sarasota, FL.
Reason for recall
"Potential that gauze pads may not be fully sterilized"
Distribution
"Distributed nationwide to AR, FL, IA, IN, KY, NY, OK, TX, UT, VA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0525-2019 | 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 | 218 cases (72, 10-ct boxes per case) | Class II | Ongoing | 12 Dec 2018 |
Context
Other enforcement events for ASO, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 Mar 2023 | WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack A | Device | Class II | 1 |
| 22 Jun 2022 | (1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU | Device | Class II | 1 |
| 2 Mar 2022 | First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon) | Device | Class II | 1 |
| 10 Jun 2015 | Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes | Device | Class II | 1 |
| 21 Aug 2013 | SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns. | Device | Class II | 1 |
| 26 Jul 2013 | CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 | Device | Class II | 9 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential that gauze pads may not be fully sterilized"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed nationwide to AR, FL, IA, IN, KY, NY, OK, TX, UT, VA."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.