FDA Device recall Z-1992-2014
Amerigel Wound Dressing 1 oz. tube
- FDA Device
- Class II
- terminated
- Published 2014-07-16
On 2014-07-16 the FDA classified a Class II recall of Amerigel Wound Dressing 1 oz. tube by Kova Laboratories, citing product may not have been manufactured pursuant to a validated process protocol and CGMP.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1992-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-21 |
| Published | 2014-07-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Kova Laboratories |
| Distribution | FL, NJ |
Product
Amerigel Wound Dressing 1 oz. tube
Reason
Product may not have been manufactured pursuant to a validated process protocol and CGMP.
Identifiers
| code_info | Lot #3WD02, Lot #3WD03, Lot #3WD04 and Lot #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-1992-2014%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.