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FDASeptember 12, 2023device

THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, a...

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

The hazard

Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

4953170409677

Recall history

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

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