RecallRadar

FDA Device recall Z-2572-2021

BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180

On 2021-10-06 the FDA classified a Class II recall of BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180 by Olympus, citing the firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labe….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2572-2021
ClassificationClass II
Statusterminated
Initiated2021-08-16
Published2021-10-06
Last updated2026-09-13 11:56 UTC
CompanyOlympus
DistributionUS

Product

BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180

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."

Identifiers

code_infoAll serial numbers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2572-2021%22

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