FDAApril 29, 2021device

Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22

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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Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22 — Recall Details · AllClear