FDADecember 1, 2023device

SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS

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

The hazard

Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to break during use, which may cause burns, procedure delays, prolonged surgery, and foreign body in patient.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

00821925043916008219250439300082192504399200821925044036008219250440740082192504387900821925043978

Recall history

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

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