Class II — Amerx Health Care Corp.
| Recalling firm | Amerx Health Care Corporation |
|---|---|
| Registered facility | Amerx Healthcare Corp (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Product did not meet specifications for Zinc Acetate (OOS). |
| Product | Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz. |
| Quantity | 6,993 Units |
| Distribution | 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, & Alaska. Bahrain & Colombia. |
| Initiated | 2016-05-20 |
| Classified | 2016-07-20 |
| Terminated | 2016-12-14 |
| Recall number | Z-2249-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Amerx Health Care Corp. (Z-2249-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74249/
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