CLASS II Device recall · Reported 24 Sep 2014 · FDA Enforcement Report

Amerigel Daily Dressing Advanced-1 Hydrogel recalled

Amerx Health Care is recalling Amerigel Daily Dressing Advanced-1 Hydrogel, distributed nationwide in the US. The recall was initiated on 11 Jul 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot codes: 2WD07.

Quantity recalled1,740 units

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-2641-2014
FDA event ID: 69083
Recalling firm: Amerx Health Care, Clearwater, FL
Classification: Class II
Status: Terminated
Recall initiated: 11 Jul 2014
FDA classified: 12 Sep 2014
Reported: 24 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Hidden Drug Ingredients
Device type: Other Medical Devices

Timeline

11 Jul 2014	Recall initiated by company
12 Sep 2014	Classified by FDA	+63 days
24 Sep 2014	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

Not approved labeling claims (antimicrobial and autolytic debridement)

Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.

Product as listed by the FDA

Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.

Where it was distributed

Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, and WV, and the countries of Canada, England, Africa, and Australia.

Nationwide Alaska Alabama Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Missouri

Questions about this recall

Why was it recalled?

Not approved labeling claims (antimicrobial and autolytic debridement)

Which lots are affected?

Lot codes: 2WD07.

Where was it sold?

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.

Other products in this recall event

3 other products · FDA event 69083

This product is part of a recall event; the main page for the event is Amerigel Hydrogel Saturated Gauze Dressing recalled by Amerx Health Care.

Reported	Class	Recall	Company	Reason	Where
24 Sep 2014	CLASS II	Amerigel Hydrogel Saturated Gauze Dressing recalled by Amerx Health Care	Amerx Health Care	Hidden Drug Ingredients	Nationwide
24 Sep 2014	CLASS II	Amerigel Wound Dressing Maximum Strength CAT# A2001 recalled	Amerx Health Care	Hidden Drug Ingredients	Nationwide
24 Sep 2014	CLASS II	Amerigel Post-Op Surgical Kits . Kit includes recalled	Amerx Health Care	Hidden Drug Ingredients	Nationwide

More recalls from Amerx Health Care

All 10

Reported	Class	Recall	Company	Reason	Where
27 Jul 2016Device	CLASS II	Amerigel Hydrogel Wound Dressing Advanced Formula recalled	Amerx Health Care	Potency & Assay	26 states
24 Jun 2015Device	CLASS II	Amerigel Hydrogel Gauze Dressing , A5002 recalled by Amerx Health Care	Amerx Health Care	Sterility	45 states
10 Dec 2014Device	CLASS II	Amerigel Daily Dressing Packets Wound management recalled	Amerx Health Care	Processing Deviation	Nationwide
10 Dec 2014Device	CLASS II	Amerigel Hydrogel Wound Dressing Wound management recalled	Amerx Health Care	Processing Deviation	Nationwide
10 Dec 2014Device	CLASS II	Amerigel Post-op Surgical Kits Wound management recalled	Amerx Health Care	Processing Deviation	Nationwide

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