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FDADecember 4, 2023device

Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940

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

The hazard

The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

Recall history

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

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Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940 — Recall Details · AllClear