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 | Not approved labeling claims (antimicrobial and autolytic debridement) |
| Product | Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management. |
| Quantity | 382,620 units |
| Distribution | 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. |
| Initiated | 2014-07-11 |
| Classified | 2014-09-12 |
| Terminated | 2015-07-22 |
| Recall number | Z-2638-2014 |
| 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-2638-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69083/
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