Class II — Xstrahl Limited
| Recalling firm | XSTRAHL LIMITED |
|---|---|
| Registered facility | XSTRAHL LIMITED (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Base plate may detach from the main body of the treatment applicator. |
| Product | Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system |
| Quantity | 120 applicators |
| Distribution | US and ALGERIA, AUSTRALIA, AUSTRIA, BULGARIA, CANADA, COSTA RICA, CROATIA, CYPRUS, DENMARK, FRANCE, GERMANY, HONG KONG, IRELAND, ITALY, KAZAKHSTAN, LATVIA, MALTA, MEXICO, NEW ZEALAND, NORWAY, PANAMA, ROMANIA, RUSSIA, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, UK, UKRAINE |
| Initiated | 2021-08-27 |
| Classified | 2021-12-16 |
| Terminated | 2026-03-04 |
| Recall number | Z-0389-2022 |
| 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-0389-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88545/
Alerts for XSTRAHL LIMITED
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.