Recall Z-1559-2022— Aizu Olympus Co., Ltd.

Name: FDA recall Z-1559-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-20

Class II · Terminated

Class II FDA medical device recall by Aizu Olympus Co., Ltd., initiated 2022-07-20, terminated 2025-01-22. It names one FDA 510(k) clearance: K201758. Product: EVIS EXERA III Bronchovideoscope. Reason: The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner..

Recalling firm: Aizu Olympus Co., Ltd.
Classification: Class II
Status: Terminated
Initiated: 2022-07-20
Terminated: 2025-01-22
Firm location: Aizuwakamatsu, Japan

510(k) clearances named in this recall

1 on FDA's record

K201758 — EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190Olympus Medical Systems Corp.·cleared 2021-01-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

EVIS EXERA III Bronchovideoscope

Reason for recall

The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner.

Data sourced from openFDA. This site is unofficial and independent of the FDA.