FDA Device recall Z-0049-2015
StarMedTec LightTrail¿ Reusable Fibers, 365 um
- FDA Device
- Class II
- terminated
- Published 2014-10-15
On 2014-10-15 the FDA classified a Class II recall of StarMedTec LightTrail¿ Reusable Fibers, 365 um by Boston Scientific, citing product is not cleared for use with lasers other than the Auriga XL system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0049-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-30 |
| Published | 2014-10-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | NY, TX |
Product
StarMedTec LightTrail¿ Reusable Fibers, 365 um; Material/Part Number: 6453
Reason
Product is not cleared for use with lasers other than the Auriga XL system
Identifiers
| code_info | Material/Part Number: 6453 Batch Code: 2011-00238 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0049-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.