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 | Nonapproved labeling claims (Sterile) |
| Product | Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management. |
| Quantity | 6,491 units |
| Distribution | Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY and Hawaii; and, the countries of Canada and Bahrain. |
| Initiated | 2015-02-25 |
| Classified | 2015-06-12 |
| Terminated | 2016-10-03 |
| Recall number | Z-1797-2015 |
| 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-1797-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71161/
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