Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a… — Class II medical device recall Z-1516-2015
Terminated recall by PhotoMedex, Inc., reported 2015-04-29, distributed nationwide. The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not consistent with t
| Recall number | Z-1516-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PhotoMedex, Inc., Horsham, PA, United States |
| Recall initiated | 2015-03-26 |
| Classified | 2015-04-23 |
| Reported by FDA | 2015-04-29 |
| Terminated | 2015-08-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 200,188 |
| Reason classes | labeling |
Product
Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and protect against abrasion, friction, desiccation and contamination.
Reason for recall
The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not consistent with the intended uses and limitations identified at the time of the clearance to market these devices.
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-1516-2015. 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.