FDA Device recall Z-1392-2022
GreenLight HPSEA Laser Fibers, UPN 0010-2092
- FDA Device
- Class III
- ongoing
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class III recall of GreenLight HPSEA Laser Fibers, UPN 0010-2092 by Boston Scientific, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1392-2022 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2022-05-31 |
| Published | 2022-07-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | AR, CA, IL, ME, MI, NC, TX |
Product
GreenLight HPSEA Laser Fibers, UPN 0010-2092
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.
Identifiers
| code_info | UDI-DI (GTIN): 00878953005522 Lot: 27770466 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1392-2022%22
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