Amerigel Hydrogel Gauze Dressing 2 x 2 — Class II medical device recall Z-1797-2015
Terminated recall by Amerx Health Care Corp., reported 2015-06-24, distributed in AK, AL, AR, AZ, CA, CO, CT, FL…. Nonapproved labeling claims (Sterile)
| Recall number | Z-1797-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerx Health Care Corp., Clearwater, FL, United States |
| Recall initiated | 2015-02-25 |
| Classified | 2015-06-12 |
| Reported by FDA | 2015-06-24 |
| Terminated | 2016-10-03 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, 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 |
| Countries outside the US | BH, CA |
| Quantity | 6,491 units |
| Reason classes | labeling, sterility |
| Lot numbers | 02521, 11406, 11414, 12439, 12466 |
Product
Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
Reason for recall
Nonapproved labeling claims (Sterile)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1797-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.