FDA Device recall Z-2639-2014
Amerigel Hydrogel Saturated Gauze Dressing
- FDA Device
- Class II
- terminated
- Published 2014-09-24
On 2014-09-24 the FDA classified a Class II recall of Amerigel Hydrogel Saturated Gauze Dressing by Amerx Health Care, citing not approved labeling claims (antimicrobial and autolytic debridement).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2639-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-11 |
| Published | 2014-09-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Amerx Health Care |
| Distribution | US |
Product
Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.
Reason
Not approved labeling claims (antimicrobial and autolytic debridement)
Identifiers
| code_info | Lot codes: 05368, 05345, 09282, 10295, 12201, 12303, 12303, 12328, 13100, 13115, and 13180. |
|---|
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-2639-2014%22
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