FDA Device recall Z-2249-2016
Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz
- FDA Device
- Class II
- terminated
- Published 2016-07-27
On 2016-07-27 the FDA classified a Class II recall of Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz by Amerx Health Care, citing product did not meet specifications for Zinc Acetate (OOS).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2249-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-20 |
| Published | 2016-07-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Amerx Health Care |
| Distribution | 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 |
Product
Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
Reason
Product did not meet specifications for Zinc Acetate (OOS).
Identifiers
| code_info | Lot # 668 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2249-2016%22
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