The Recall Desk
HighFDA (Devices)·Z-1176-2019·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (high UV output) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

ProSun International, LLC is recalling 31 units of the ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. The affected devices are labeled as PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI INTENSIVE BRONZE, or PROSUN ONYX 32 SLI INTENSIVE BRONZE. The recall involves 31 of the 177 devices distributed nationwide to 17 states, including California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Maine, Michigan, North Carolina, New Jersey, New York, Ohio, Oregon, Tennessee, Texas, and Wisconsin.

The recall was initiated because ProSun International discovered discrepancies in their Quality Control Checklist documentation. These discrepancies could result in high UV output from the tanning beds. The source text does not report any illnesses or injuries associated with the use of these devices.

Consumers who own one of the affected serial numbers should stop using the tanning bed and contact ProSun International for instructions on how to proceed. The specific serial numbers affected are listed in the official recall notice.

The recalled product

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
Manufacturer
ProSun International, LLC
Category
Medical Device — Tanning Bed
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial Numbers: UNO32SLII4W0048
  • UNO32SLII1X0052
  • UNO32SLII1X0063
  • UNATF32SLII1X0028
  • UNO32SLII1X0064
  • UNO32SLII1X0065
  • UNO32SLII1X0067
  • UNO32SLII1X0068
  • UNO32SLII2X0071
  • UNO32SLII2X0072
  • UNO32SLII3V0070
  • UNO32SLII2X0075
  • UNO32SLII1X0069
  • UNO32SLII2X0073
  • UNATF32SLII2X0031
  • UNATF32SLII2X0030
  • UNO32SLII2X0084
  • UNO32SLII2X0082
  • UNO32SLII2X0083
  • UNO32SLII2X0081

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

Part of a larger recall action

This product is one of 2 recalled by ProSun International, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · ProSun International, LLC

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Same hazard · uv exposure

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