FDAApril 29, 2021device

Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576

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

The hazard

No 510k for the product to be used in a natural or surgical opening to the body

What to do

FDA enforcement status: Terminated

Brands named

exact medical manufacturingexactexact medical

Recall history

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

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