Sundream 12 V tanning bed — Class II medical device recall Z-0319-2018
Terminated recall by ProSun International, LLC, reported 2018-01-17, distributed in AK, AL, AZ, CA, CT, FL, GA, IN…. The 30 minute maximum tanning time has been reduced to 20 minutes.
| Recall number | Z-0319-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ProSun International, LLC, Saint Petersburg, FL, United States |
| Recall initiated | 2017-12-02 |
| Classified | 2018-01-05 |
| Reported by FDA | 2018-01-17 |
| Terminated | 2026-02-18 |
| Distributed | 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 |
| Quantity | 75 units |
| Serial numbers | SUN12VH1R0001, SUN12VH1R0002, SUN12VH1R0003, SUN12VH1R0004, SUN12VH1R0005, SUN12VH1R0006, SUN12VH1R0007, SUN12VH1R0009, SUN12VH1R0010, SUN12VH1R0011, SUN12VH1R0012, SUN12VH1R0013, SUN12VH1R0015, SUN12VH1R0016, SUN12VH1R0017, SUN12VH1R0018, SUN12VH1R0019, SUN12VH1R0020, SUN12VH1R0021, SUN12VH1R0022, SUN12VH1R0023, SUN12VH1R0024, SUN12VH1R0025, SUN12VH1R0026, SUN12VH1R0027 and 50 more |
| Model numbers | 12V |
Product
Sundream 12 V tanning bed
Reason for recall
The 30 minute maximum tanning time has been reduced to 20 minutes.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0319-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.