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FDAAugust 12, 2022device

Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.

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

The hazard

An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

00821925044579

Recall history

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

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