The Recall Desk

FDA (Devices) recall action 82346

ProSun International, LLC recalled 2 products on 2019-04-24

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-04-24
Critical
0
Units
—

Why these products were recalled

ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2019-04-24

    ProSun Onyx 32 Sli Intensive Tanning Bed Recalled for UV Output Discrepancies

    ProSun International is recalling 31 Onyx 32 Sli Intensive tanning beds due to quality control documentation discrepancies that could result in high UV output.

    Product
    ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI INTENSIVE BRONZE, PROSUN ONYX 32 SLI INTENSIVE BRONZE Tanning of the skin
    Category
    Distribution
    17 states
  • HighFDA (Devices)··2019-04-24

    ProSun V3 42 Tanning Beds Recalled for Potential High UV Output

    ProSun International is recalling nine specific tanning beds due to quality control documentation discrepancies that could result in high UV output.

    Product
    ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following: PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE (TMAX READY), PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE, PROSUN V3 42 HIGH INTENSIVE (160W) RED, PROSUN V3 42 HIGH INTENSIVE (160W) PEARL W
    Category
    Distribution
    17 states