Auriga XL 4007 Laser System — Class II medical device recall Z-0898-2018
Terminated recall by Boston Scientific Corporation, reported 2018-03-14. Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the
| Recall number | Z-0898-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2017-09-22 |
| Classified | 2018-03-05 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2018-08-14 |
| Countries outside the US | AU, DE, ES, FR, IT, RO, VN |
| Quantity | 9 |
| Serial numbers | 20465096, 20503137, 20509715, 20520960, 20541967, 20546219, 20546440, 20575512, 20575518 |
| Model numbers | M0068FS4007G0 |
Product
Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.
Reason for recall
Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console.
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-0898-2018. 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.