EVIS EXERA III BRONCHOVIDEOSCOPE recallZ-1559-2022 · Aizu Olympus Co., Ltd. · initiated Jul 20, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Aizu Olympus Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner.
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected]. Customers reporting complaints associated with this recall event are to call Olympus at 1-800-848-9024, option 1.
Recall details
- Recall number
- Z-1559-2022
- Status
- Terminated
- Initiated by the company
- Jul 20, 2022
- Recalling firm
- Aizu Olympus Co., Ltd.
- Product code
- EOQ
- FDA submissions
- K201758
- Distribution
- US Nationwide distribution in the states of FL, IL, NC, PA & TX.
Product description
EVIS EXERA III Bronchovideoscope
Code information (models, lots, serial numbers)
UDI-DI: 04953170342134; Serial No. 2911858; Model No. BF-XP190.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1,146 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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