FDA Device recall Z-1797-2015
Amerigel Hydrogel Gauze Dressing 2 x 2, A5002
- FDA Device
- Class II
- terminated
- Published 2015-06-24
On 2015-06-24 the FDA classified a Class II recall of Amerigel Hydrogel Gauze Dressing 2 x 2, A5002 by Amerx Health Care, citing nonapproved labeling claims (Sterile).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1797-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-25 |
| Published | 2015-06-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Amerx Health Care |
| Distribution | 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 |
Product
Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
Reason
Nonapproved labeling claims (Sterile)
Identifiers
| code_info | ALL Lots - 11406, 11414, 12439, 12466, and 02521. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1797-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.