FDA Medical Device Recalls (openFDA)
Aizu Olympus Co., Ltd.: EVIS EXERA III Bronchovideoscope
- Recall number
- Z-1559-2022
- Recalling firm
- Aizu Olympus Co., Ltd.
- Product
- EVIS EXERA III Bronchovideoscope
- Status
- Terminated
- Initiated
- 2022-07-20
- Posted
- not on file
- Terminated
- 2025-01-22
- Reason
- The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner.
- Root cause
- Under Investigation by firm
- Action
- An Urgent Field Safety Notice was distributed by the recalling firm on 07/20/2022 notifying consignees that a bronchoscope utilized in a veterinary endoscopy procedure was subsequently distributed as a service loaner in error. The device was utilized in a single procedure on a cat. Actions to be taken by customers include evaluating the situation according to hospital procedure to determine if patient notification or follow up may be required, review patient records and report any potentially adverse events to Olympus and FDA and acknowledge receipt of the recall notification by email or through the Olympus recall portal at https://olympusamerica.com/recall. Customers with any questions may contact Cynthia Ow by phone at (647)999-3203 or by email at Cynthia.Ow@Olympus.com. Customers reporting complaints associated with this recall event are to call Olympus at 1-800-848-9024, option 1.
- Quantity
- not on file
- Distribution
- US Nationwide distribution in the states of FL, IL, NC, PA & TX.
- Lot, serial or model codes
- UDI-DI: 04953170342134; Serial No. 2911858; Model No. BF-XP190.
- 510(k) numbers
- ["K201758"]
- PMA numbers
- not on file
- Product code
- EOQ
- Firm FEI
- 3002964398
- Firm city
- Aizuwakamatsu
- Firm state
- 1 Chome
- Firm country
- Japan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28