Device recall: EVIS EXERA III Bronchovideoscope

Class II FDA enforcement event 90664. Recall start date: 20 Jul 2022. Status in the FDA record: Terminated. Termination date: 22 Jan 2025.

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Aizu Olympus Co., Ltd. started this device recall on 20 Jul 2022. The firm address in the FDA record is in Aizuwakamatsu. FDA put the recall in Class II. FDA event 90664 has 1 product record. The first FDA enforcement report date is 31 Aug 2022. The record gives the status Terminated, with the termination date 22 Jan 2025.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US Nationwide distribution in the states of FL, IL, NC, PA & TX.

Recalling firm

Aizu Olympus Co., Ltd., Aizuwakamatsu, Japan.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 90664: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1559-2022	EVIS EXERA III Bronchovideoscope		Class II	Terminated	31 Aug 2022

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2022: 839
Share of these events in Class II: 88%
Product records in this event: 1Median of the firm: 5
Events of the firm on the register: 4

Other events of the firm

Other FDA enforcement events of Aizu Olympus Co., Ltd.
Initiated	Product (first record)	Type	Class	Records
31 Oct 2025	Olympus OER-Elite	Device	Class II	3
16 Oct 2023	CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE	Device	Class II	5
25 Sep 2023	Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150,	Device	Class II	22

Aizu Olympus Co., Ltd.: all 4 events

Official channels

FDA enforcement report Z-1559-2022The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 90664. https://recallregister.com/fda/ii/90664/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Nationwide distribution in the states of FL, IL, NC, PA & TX.
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2022 have the same class?: 88% of the 839 device events that started in 2022 are in Class II.
How many FDA recalls does Aizu Olympus Co., Ltd. have?: Aizu Olympus Co., Ltd. is the recalling firm in 4 enforcement events on this register. This event is 1 of them.