Class III — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Ongoing |
| Reason | Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and fiber card. This may result in prolonged procedure while the fiber is being replaced. |
| Product | GreenLight HPSEA Laser Fibers, UPN 0010-2092 |
| Quantity | 57 |
| Distribution | Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France. |
| Initiated | 2022-05-31 |
| Classified | 2022-07-15 |
| Recall number | Z-1392-2022 |
| 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 III recall — Boston Scientific Corporation (Z-1392-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90458/
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