ProSun Onyx 32 Sli Intensive — Class II medical device recall Z-1176-2019
Terminated recall by ProSun International, LLC, reported 2019-04-24, distributed nationwide. ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which coul
| Recall number | Z-1176-2019 |
|---|---|
| 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 | 2018-12-10 |
| Classified | 2019-04-16 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2023-05-02 |
| Distributed | Nationwide (US) |
| Serial numbers | UNATF32SLII1X0028, UNATF32SLII2X0030, UNATF32SLII2X0031, UNATF32SLIIX0027, UNO32SLII1X0052, UNO32SLII1X0056, UNO32SLII1X0057, UNO32SLII1X0063, UNO32SLII1X0064, UNO32SLII1X0065, UNO32SLII1X0067, UNO32SLII1X0068, UNO32SLII1X0069, UNO32SLII2X0071, UNO32SLII2X0072, UNO32SLII2X0073, UNO32SLII2X0075, UNO32SLII2X0079, UNO32SLII2X0081, UNO32SLII2X0082, UNO32SLII2X0083, UNO32SLII2X0084, UNO32SLII2X0091, UNO32SLII2X0094, UNO32SLII3V0070 and 6 more |
| Model numbers | 32/1 |
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
Reason for recall
ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
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-1176-2019. 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.