🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: December 10, 2018 ProSun International Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: UNO32SLII4W0048, UNO32SLII1X0052, UNO32SLII1X0063, UNATF32SLII1X0028, UNO32SLII1X0064, UNO32SLII1X0065, UNO32SLII1X0067, UNO32SLII1X0068, UNO32SLII2X0071, UNO32SLII2X0072, UNO32SLII3V0070, UNO32SLII2X0075, UNO32SLII1X0069, UNO32SLII2X0073, UNATF32SLII2X0031, UNATF32SLII2X0030, UNO32SLII2X0084, UNO32SLII2X0082, UNO32SLII2X0083, UNO32SLII2X0081, UNO32SLII2X0091, UNO32SLII4W0050, UNO32SLII4W0047, UNO32SLII3W0011, UNO32SLII2X0079, UNO32SLII3X0095, UNO32SLII2X0094, UNO32SLII1X0056, UNO32SLII1X0057, UNATF32SLIIX0027, UNO32SLII3X0096
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
ProSun International, LLC
Reason for Recall:
ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Serial Numbers: UNO32SLII4W0048, UNO32SLII1X0052, UNO32SLII1X0063, UNATF32SLII1X0028, UNO32SLII1X0064, UNO32SLII1X0065, UNO32SLII1X0067, UNO32SLII1X0068, UNO32SLII2X0071, UNO32SLII2X0072, UNO32SLII3V0070, UNO32SLII2X0075, UNO32SLII1X0069, UNO32SLII2X0073, UNATF32SLII2X0031, UNATF32SLII2X0030, UNO32SLII2X0084, UNO32SLII2X0082, UNO32SLII2X0083, UNO32SLII2X0081, UNO32SLII2X0091, UNO32SLII4W0050, UNO32SLII4W0047, UNO32SLII3W0011, UNO32SLII2X0079, UNO32SLII3X0095, UNO32SLII2X0094, UNO32SLII1X0056, UNO32SLII1X0057, UNATF32SLIIX0027, UNO32SLII3X0096

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1176-2019

Related Recalls

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 WHITE TMAX READY

ProSun International

Class I - Dangerous

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

Dec 10, 2018 Infusion Pumps Nationwide View Details →