GreenLight HPSEA Laser Fibers — Class III medical device recall Z-1392-2022
Ongoing recall by Boston Scientific Corporation, reported 2022-07-27, distributed in AR, CA, IL, ME, MI, NC, TX. Several complaints were received for the affected lot; users received a "Fiber type does not match card type"
| Recall number | Z-1392-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2022-05-31 |
| Classified | 2022-07-15 |
| Reported by FDA | 2022-07-27 |
| Distributed | AR, CA, IL, ME, MI, NC, TX |
| Countries outside the US | AU, CA, FR |
| Quantity | 57 |
| UPC / GTIN / UDI-DI | 00878953005522 |
| Lot numbers | 27770466 |
Product
GreenLight HPSEA Laser Fibers, UPN 0010-2092
Reason for recall
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.
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-1392-2022. 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.