Saint Petersburg, FL, United States
ProSun International, LLC recalls
2 recalls recorded since 2018, most recently on 10 December 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 10 December 2018
- Terminated
- 2 May 2023
- Reason
- ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
- Distribution
- US Nationwide distribution to states of: CA, CO, FL, GA, IL, KY, LA, ME, MI, NC, NJ, NY, OH, OR, TN, TX, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1176-2019, Z-1177-2019
- 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, PRO
- 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 INTENS
Terminated Class II Medical devices
- Recall started
- 2 December 2017
- Terminated
- 18 February 2026
- Reason
- The 30 minute maximum tanning time has been reduced to 20 minutes.
- Distribution
- Distributed domestically to AK, AL, AZ, CA, CT, FL, GA, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0319-2018
- Sundream 12 V tanning bed
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.