Pure Rayz — Class II medical device recall Z-2975-2018
Terminated recall by Quasar Bio-Tech, Inc., reported 2018-09-12, distributed nationwide. Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and
| Recall number | Z-2975-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quasar Bio-Tech, Inc., Sarasota, FL, United States |
| Recall initiated | 2018-06-29 |
| Classified | 2018-09-05 |
| Reported by FDA | 2018-09-12 |
| Terminated | 2019-08-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CN, GB, NL |
| Quantity | 6,783 units |
| UPC / GTIN / UDI-DI | 00091037461407 |
Product
Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
Reason for recall
Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
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-2975-2018. 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.