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FDA Blocks Some Olympus Endoscopes From Entering US

 
• By Brian Bossetta

After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.

(Shutterstock)

After extensive efforts to address compliance issues related to various endoscopes from Japanese device maker Olympus fell short, the US Food and Drug Administration has issued an import alert to prevent future shipment of the devices into the country.

Specifically, in the alert issued June 24, the agency seeks to stop the entry of the firm’s ureterorenoscopes and bronchoscopes,...

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