FDA (Devices) recall action 88562
The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Olympus Corporation issued updated reprocessing instructions for the BF-XP60 bronchofiberscope to align with FDA 2015 guidance on medical device reprocessing validation and labeling.
Olympus is recalling approximately 484 BF-3C40 OES Bronchofiberscopes due to reprocessing instruction updates. The manufacturer is issuing validated instructions per FDA 2015 guidance for proper device reprocessing.
Olympus Corporation is issuing updated reprocessing instructions for 293 BF-XT160 bronchovideoscopes to comply with FDA 2015 guidance. Healthcare facilities should implement the new sterilization and disinfection procedures.
Olympus is updating reprocessing instructions for the BF-N20 Bronchofiberscope to comply with FDA 2015 guidance on medical device reprocessing validation.
Olympus Corporation is issuing updated reprocessing instructions for the BF-XP160F EVIS EXERA Bronchovideoscope according to FDA 2015 guidance. All serial numbers are affected.
Olympus Corporation is recalling 431 BF-Q180-AC EVIS EXERA II Bronchovideoscopes to issue validated reprocessing instructions aligned with FDA 2015 guidance.
Olympus Corporation is issuing updated reprocessing instructions for the BF-1T180 EVIS EXERA II Bronchovideoscope to comply with FDA 2015 guidance on medical device reprocessing validation.
Olympus Corporation issued updated reprocessing instructions for 1,177 BF-P180 EVIS EXERA II Bronchovideoscopes to ensure compliance with FDA validation standards for medical device sterilization.
Olympus Corporation is issuing updated reprocessing instructions for the BF-1T60 bronchofiberscope to comply with FDA 2015 guidance on device reprocessing in health care settings.
Olympus Corporation has issued new, validated reprocessing instructions for the BF-P60 OES Bronchofiberscope to comply with FDA guidance. The recall affects 1,030 devices distributed nationwide and internationally.