Class II — Xstrahl Limited
| Recalling firm | XSTRAHL LIMITED |
|---|---|
| Registered facility | XSTRAHL LIMITED (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | There is a potential compatibility issue with the systems and replacement treatment applicators. |
| Product | X80 RADiant Photoelectric Therapy System |
| Quantity | 7 devices; 70 treatment applicators |
| Distribution | US Distribution FL, CA, KY |
| Initiated | 2022-04-27 |
| Classified | 2022-07-19 |
| Recall number | Z-1404-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Xstrahl Limited (Z-1404-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90231/
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