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U.S. Department of Health and Human Services

Safety

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Olympus America Video Bronchoscopes

Audience: Hospital Administrators, Risk Managers, Pulmonologists

The FDA Center for Devices and Radiological Health notified healthcare professionals of a voluntary recall of Olympus America, Inc. bronchoscopes after a medical facility reported bacteria growth which possibly caused two illnesses. The bronchoscopes were distributed nationwide between June 5, 1997 and December 10, 2001.

Olympus issued a recall notification letter to hospitals and medical facilities about the suspect bronchoscopes on November 30, 2001, requesting they be returned to Olympus for modification. On February 27, 2002, Olympus issued a second recall notification letter to facilities that did not respond to their first letter. See the complete FDA/CDRH notification for additional information, including specific model numbers affected.

[March 20, 2002 - Device Recall - FDA]

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