FDA Device recall Z-0498-2015
Amerigel Post-op Surgical Kits Wound management
- FDA Device
- Class II
- terminated
- Published 2014-12-10
On 2014-12-10 the FDA classified a Class II recall of Amerigel Post-op Surgical Kits Wound management by Amerx Health Care, citing formulation deviation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0498-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-26 |
| Published | 2014-12-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Amerx Health Care |
| Distribution | US |
Product
Amerigel Post-op Surgical Kits Wound management
Reason
Formulation deviation
Identifiers
| code_info | Model # A2002, Lot #s: JCA0086, JCA0087, JCA0088, JCA0089, JCA0090, JCA0091, JCA0092, JCA0093, JCA0094, JCA0095, JCA009…Model # A2002, Lot #s: JCA0086, JCA0087, JCA0088, JCA0089, JCA0090, JCA0091, JCA0092, JCA0093, JCA0094, JCA0095, JCA0096, JCA0097, JCA0098, JCA0099, JCA0100, JCA0101, JCA0102, JCA0103, JCA0104, JCA0105, JCA0106 |
|---|
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-0498-2015%22
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