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Recall

Class II — Boston Scientific Corporation

Recalling firmBoston Scientific Corporation
Registered facilityView this company's 37 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonProduct is not cleared for use with lasers other than the Auriga XL system
ProductStarMedTec LightTrail® Reusable Fibers, 800 um; Material/Part Number: 6457
Quantity33 units
DistributionUS Distribution including the states of NY and TX.
Initiated2014-09-30
Classified2014-10-08
Terminated2014-11-26
Recall numberZ-0051-2015
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Boston Scientific Corporation (Z-0051-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69404/

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