Amerigel Hydrogel Wound Dressing Advanced Formula for wound… — Class II medical device recall Z-2249-2016
Terminated recall by Amerx Health Care Corp., reported 2016-07-27, distributed in AK, AR, AZ, CA, CO, CT, FL, GA…. Product did not meet specifications for Zinc Acetate (OOS).
| Recall number | Z-2249-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerx Health Care Corp., Clearwater, FL, United States |
| Recall initiated | 2016-05-20 |
| Classified | 2016-07-20 |
| Reported by FDA | 2016-07-27 |
| Terminated | 2016-12-14 |
| Distributed | AK, AR, AZ, CA, CO, CT, FL, GA, IL, IN, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA |
| Countries outside the US | BH, CO |
| Quantity | 6,993 units |
| Reason classes | specification failure |
| Lot numbers | 668 |
Product
Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
Reason for recall
Product did not meet specifications for Zinc Acetate (OOS).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2249-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.