Amerigel Wound Dressing 55 gallons/drum — Class II medical device recall Z-1993-2014
Terminated recall by Kova Laboratories, Inc., reported 2014-07-16, distributed in FL, NJ. Product may not have been manufactured pursuant to a validated process protocol and CGMP.
| Recall number | Z-1993-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kova Laboratories, Inc., Margate, FL, United States |
| Recall initiated | 2014-03-21 |
| Classified | 2014-07-04 |
| Reported by FDA | 2014-07-16 |
| Terminated | 2016-09-12 |
| Distributed | FL, NJ |
| Quantity | 3 drums |
| Reason classes | cgmp |
| Lot numbers | 3WD05 |
Product
Amerigel Wound Dressing 55 gallons/drum
Reason for recall
Product may not have been manufactured pursuant to a validated process protocol and CGMP.
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-1993-2014. 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.