FDASeptember 10, 2021device

IUD Insertion Kit

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

The hazard

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

What to do

FDA enforcement status: Ongoing

Brands named

stradis medical llc dba stradis healthcarestradisstradis medical

Recall history

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

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