The Recall Desk

Manufacturer

PhotoMedex, Inc.

2 recalls in our database name PhotoMedex, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2015-04-29

Of the 2 recalls from PhotoMedex, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • ModerateFDA (Devices)·Z-1516-2015·2015-04-29

    PhotoMedex Recalls Iamin Medical Devices Due to Inconsistent Labeling

    PhotoMedex, Inc. is recalling Iamin Moist Dressings and Hydrating Gel because their labeling does not match the intended uses approved by the FDA.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0005-2014·2013-10-09

    PhotoMedex Recalls SLT Fiber Delivery Systems Due to Sterility Concerns

    PhotoMedex is recalling 549 units of SLT Fiber Delivery Systems because some may not have been sealed appropriately, compromising the sterile barrier.

    Product
    The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product N
    Category
    Medical Device
    Distribution
    3 states