PhotoMedex, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1516-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 26, 2015

Date Posted: April 29, 2015

Recall Number: Z-1516-2015

Event ID: 70838

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.

Status: Terminated

Product Quantity: 200188

Code Information:

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

Distribution Pattern:

Nationwide and Internationally, including Canada.

Voluntary or Mandated:

Voluntary: Firm initiated