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 | Formulation deviation |
| Product | Amerigel Saturated Gauze Dressing Wound management |
| Quantity | 21,108 |
| Distribution | Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, 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, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia. |
| Initiated | 2014-09-26 |
| Classified | 2014-12-03 |
| Terminated | 2016-10-03 |
| Recall number | Z-0500-2015 |
| 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-0500-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69394/
Alerts for Amerx Health Care Corporation
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.