Amerigel Post-op Surgical Kits Wound management — Class II medical device recall Z-0498-2015
Terminated recall by Amerx Health Care Corp., reported 2014-12-10, distributed nationwide. Formulation deviation
| Recall number | Z-0498-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerx Health Care Corp., Clearwater, FL, United States |
| Recall initiated | 2014-09-26 |
| Classified | 2014-12-03 |
| Reported by FDA | 2014-12-10 |
| Terminated | 2016-10-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, GB |
| Quantity | 79,677 |
| Lot numbers | JCA0086, JCA0087, JCA0088, JCA0089, JCA0090, JCA0091, JCA0092, JCA0093, JCA0094, JCA0095, JCA0096, JCA0097, JCA0098, JCA0099, JCA0100, JCA0101, JCA0102, JCA0103, JCA0104, JCA0105, JCA0106 |
| Model numbers | A2002 |
Product
Amerigel Post-op Surgical Kits Wound management
Reason for recall
Formulation deviation
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-0498-2015. 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.