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FDADecember 4, 2023device

SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

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

The hazard

Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

00821925043985

Recall history

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

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