FDA Device recall Z-0497-2015
Amerigel Hydrogel Wound Dressing Wound management
- FDA Device
- Class II
- terminated
- Published 2014-12-10
On 2014-12-10 the FDA classified a Class II recall of Amerigel Hydrogel Wound Dressing Wound management by Amerx Health Care, citing formulation deviation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0497-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-26 |
| Published | 2014-12-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Amerx Health Care |
| Distribution | US |
Product
Amerigel Hydrogel Wound Dressing Wound management
Reason
Formulation deviation
Identifiers
| code_info | Model # A2001, Lot #s: YWD13, YWD15, YWD16, 2WD01, 2WD02, 2WD03, 2WD04, 2WD05, 2WD08, 2WD09, 2WD11, 2WD13, 2WD14, 2WD15…Model # A2001, Lot #s: YWD13, YWD15, YWD16, 2WD01, 2WD02, 2WD03, 2WD04, 2WD05, 2WD08, 2WD09, 2WD11, 2WD13, 2WD14, 2WD15, 2WD17, 2WD18, 3WD01, 3WD02, 3WD03, 3WD04, 3WD05 |
|---|
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-0497-2015%22
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