Recall archive / FDA device enforcement
GreenLight HPSEA Laser Fibers, UPN 0010-2092 — FDA record Z-1392-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 31, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class III
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 57
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1392-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI (GTIN): 00878953005522 Lot: 27770466 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 27, 2022
- Recall initiation date
- May 31, 2022
- Center classification date
- Jul 15, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.