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FDAFebruary 3, 2021device

Thread-like wire marker

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

The hazard

This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion. There is a potential risk that wire fragments are not removed during the procedure and stays inside the patient's body.

What to do

FDA enforcement status: Terminated

Brands named

somatex medical technologiessomatexsomatex medical

Recall history

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

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Thread-like wire marker — Recall Details · AllClear