CLASS II ONGOING Device recall · Reported 12 Dec 2018 · FDA Enforcement Report

Family Wellness First Aid Sterile Gauze Pad White, bleached recalled

ASO is recalling Family Wellness First Aid Sterile Gauze Pad White, bleached, non-woven, rayon/polyester, distributed nationwide in the US. The recall was initiated on 16 Oct 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesASO Item No. 780655, Batch/Lot # 2384-20180524

Quantity recalled218 cases (72, 10-ct boxes per case)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0525-2019
FDA event ID: 81555
Recalling firm: ASO, Sarasota, FL
Classification: Class II
Status: Ongoing
Recall initiated: 16 Oct 2018
FDA classified: 30 Nov 2018
Reported: 12 Dec 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

16 Oct 2018	Recall initiated by company
30 Nov 2018	Classified by FDA	+45 days
12 Dec 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential that gauze pads may not be fully sterilized

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Arkansas Florida Iowa Indiana Kentucky New York Oklahoma Texas Utah Virginia

Questions about this recall

Why was it recalled?

Potential that gauze pads may not be fully sterilized

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from ASO

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Reported	Class	Recall	Company	Reason	Where
10 May 2023Device	CLASS II	Walgreens Bandages recalled by ASO	ASO	Packaging Defects	Nationwide
24 Aug 2022Device	CLASS II	CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads recalled	ASO	Packaging Defects	Nationwide
11 May 2022Device	CLASS II	First Aid Kits containing acetaminophen under brand names recalledacetaminophen under	ASO	Other	Nationwide
2 Sep 2015Device	CLASS II	Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes recalled	ASO	Other	RI
9 Oct 2013Device	CLASS II	Shopko Waterproof Adhesive Pads Antibacterial recalled by ASO	ASO	Other	IN, NE, WI

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