Z-1559-2022Class II

EVIS EXERA III Bronchovideoscope

Name: Z-1559-2022 EVIS EXERA III Bronchovideoscope
Creator: Aizu Olympus Co., Ltd.
Published: 2022-07-20
License: https://open.fda.gov/license/

Aizu Olympus Co., Ltd. / initiated 2022-07-20 / Terminated

FDA source

Aizu Olympus Co., Ltd. began a recall of EVIS EXERA III Bronchovideoscope on 2022-07-20. FDA classified it as Class II and gives the reason as "The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1559-2022
Classification: Class II
Status: Terminated
Initiated: 2022-07-20
Posted: 2022-08-19
Terminated: 2025-01-22
Recalling firm: Aizu Olympus Co., Ltd.
Product: EVIS EXERA III Bronchovideoscope
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner.
FDA 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 [email protected]. Customers reporting complaints associated with this recall event are to call Olympus at 1-800-848-9024, option 1.
Distribution: US Nationwide distribution in the states of FL, IL, NC, PA & TX.
Product codes and lots: UDI-DI: 04953170342134; Serial No. 2911858; Model No. BF-XP190.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1559-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1559-2022	Class II	Terminated	Voluntary: Firm initiated	2022-08-31	2022-08-19

Product code EOQ

K201758Class IIEVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190Olympus Medical Systems Corp. / cleared 2021-01-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)