The Recall Desk

Manufacturer

Strata Skin Sciences, Inc.

1 recall in our database name Strata Skin Sciences, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2017-04-05

Of the 1 recalls from Strata Skin Sciences, 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.

1–1 of 1

  • HighFDA (Devices)·Z-1455-2017·2017-04-05

    Strata Skin Sciences Recalls XTRAC Excimer Lasers Due to Shorted Wires

    Strata Skin Sciences is recalling XTRAC Excimer Lasers because loose switch control wires may short, leading to unintentional laser firing.

    Product
    XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma.
    Category
    Medical Device
    Distribution
    Distributed nationwide