CLASS II Device recall · Reported 29 Apr 2015 · FDA Enforcement Report
Iamin Moist Dressing and the Iamin Hydrating Gel recalled by PhotoMedex
PhotoMedex is recalling Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on, distributed nationwide in the US. The recall was initiated on 26 Mar 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1516-2015
- FDA event ID
- 70838
- Recalling firm
- PhotoMedex, Horsham, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Mar 2015
- FDA classified
- 23 Apr 2015
- Reported
- 29 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 26 Mar 2015 | Recall initiated by company | |
| 23 Apr 2015 | Classified by FDA | +28 days |
| 29 Apr 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Internationally, including Canada.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Item No. Description GCICK Iamin After-Care Kit GC044-1 Iamin Moist Dressing (1) GCIMD Iamin Moist Dressing Kit (7) GCIHG Iamin Hydrating Gel Kit M40329 Iamin Hydrating Gel 15g 20920. Insert, Iamin Care 6 x 4 20939. Iamin Kit Box (GCICK/GCICK) P-GCI624A Iamin Patient Brochure (25) PK PNI-624A Iamin Detail Brochure (25) PK
Where was it sold?
Nationwide and Internationally, including Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from PhotoMedex
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|---|---|---|---|---|---|
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