Amerigel Hydrogel Saturated Gauze Dressing — Class II medical device recall Z-2639-2014
Terminated recall by Amerx Health Care Corp., reported 2014-09-24, distributed nationwide. Not approved labeling claims (antimicrobial and autolytic debridement)
| Recall number | Z-2639-2014 |
|---|---|
| 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 | 2014-07-11 |
| Classified | 2014-09-12 |
| Reported by FDA | 2014-09-24 |
| Terminated | 2015-07-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, GB |
| Quantity | 21,108 units |
| Reason classes | labeling, unapproved product |
| Lot numbers | 05345, 05368, 09282, 10295, 12201, 12303, 12328, 13100, 13115, 13180 |
| Model numbers | A5002 |
Product
Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.
Reason for recall
Not approved labeling claims (antimicrobial and autolytic debridement)
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-2639-2014. 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.