Skip to content
Recall Observatory FDA recall evidence

Device product

BF-P60 OES Bronchofiberscope, Model No. BF-P60

Z-2568-2021

August 16, 2021

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 88562
Status
Terminated
Classification
Class II
Quantity
1030
Official record key
device-enforcement:Z-2568-2021

Official wording

Reason: 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."

Code information: All serial numbers

Distribution pattern: Domestic distribution nationwide. Product also distributed globally.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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."