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FDAMay 26, 2022device

SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (Pouch) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX200BS (Carton) - 200 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX550S (Carton) - 550 M...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.

What to do

FDA enforcement status: Terminated

Brands named

olympus

UPCs

00821925043923008219250439850082192504404300821925043930

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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