CLASS II ONGOING Device recall · Reported 24 Aug 2022 · FDA Enforcement Report

CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads recalled

ASO is recalling CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads, distributed nationwide in the US. The recall was initiated on 22 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem 781083: Lot numbers 2384-20201116, 2384-20201123, 2384-20201212, 2384-20201226, 2384-20210111, 2384-20210120, 2384-20210306, 2384-20210327, 2384-20210329, 2384-20210411, 2384-20210522, 2384-20210528, 2384-20210604, 2384-20210610, 2384-20210615, 2384-20210619; UPC 050428310229, UDI: 050428310229. Item 781240: Lot numbers 2384-20201109, 2384-20201214, 2384-20201220, 2384-20201223, 2384-20210117, 2384-20210127, 2384-20210320, 2384-20210501, 2384-20210502, 2384-20210508, 2384-20210523, 2384-20210703, 2384-20210904, 2384-20210910; UPC 5042899705, UDI: 050428297056 Item 192636: equate First Aid Kit lot #00163199, generic sterile trauma pad lot #2384-20210829, UPC: 627735013176, UDI: N/A.

Quantity recalled274,458 retail packages

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-1517-2022
FDA event ID: 90538
Recalling firm: ASO, Sarasota, FL
Classification: Class II
Status: Ongoing
Recall initiated: 22 Jun 2022
FDA classified: 12 Aug 2022
Reported: 24 Aug 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Surgical Instruments

Timeline

22 Jun 2022	Recall initiated by company
12 Aug 2022	Classified by FDA	+51 days
24 Aug 2022	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

The product falls apart during handling after removal from its primary packaging.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

(1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111 (2) CVS Health 30 Piece Wound Care Kit, For Large Size Wounds, ASO Item No. 781240, SKU 998842; and (3) equate First Aid Kit, 120 Items, containing 1 generic Sterile Trauma Pad 5 in. x 9 in., ASO Item No. 192636, SKU #30174479.

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI SC, TN, TX, and VA. The country of Canada.

Nationwide Alabama California Florida Indiana Michigan Missouri New Jersey New York Pennsylvania Rhode Island South Carolina Tennessee Texas Virginia

Stores named: Walmart, CVS

Questions about this recall

Why was it recalled?

The product falls apart during handling after removal from its primary packaging.

Which lots are affected?

Item 781083: Lot numbers 2384-20201116, 2384-20201123, 2384-20201212, 2384-20201226, 2384-20210111, 2384-20210120, 2384-20210306, 2384-20210327, 2384-20210329, 2384-20210411, 2384-20210522, 2384-20210528, 2384-20210604, 2384-20210610, 2384-20210615, 2384-20210619; UPC 050428310229, UDI: 050428310229. Item 781240: Lot numbers 2384-20201109, 2384-20201214, 2384-20201220, 2384-20201223, 2384-20210117, 2384-20210127, 2384-20210320, 2384-20210501, 2384-20210502, 2384-20210508, 2384-20210523, 2384-20210703, 2384-20210904, 2384-20210910; UPC 5042899705, UDI: 050428297056 Item 192636: equate First Aid Kit lot #00163199, generic sterile trauma pad lot #2384-20210829, UPC: 627735013176, UDI: N/A.

Where was it sold?

Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI SC, TN, TX, and VA. The country of Canada.

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.

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