Z-0415-2024Class II

Cf-Hq190l Evis Exera III Colonovideoscope

Name: Z-0415-2024 Cf-Hq190l Evis Exera III Colonovideoscope
Creator: Aizu Olympus Co., Ltd.
Published: 2023-10-16
License: https://open.fda.gov/license/

Aizu Olympus Co., Ltd. / initiated 2023-10-16 / Open, Classified / root cause: manufacturing process

FDA source

Aizu Olympus Co., Ltd. began a recall of CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE on 2023-10-16. FDA classified it as Class II and gives the reason as "Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0415-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-16
Posted: 2023-11-29
Recalling firm: Aizu Olympus Co., Ltd.
Product: Cf-Hq190l Evis Exera III Colonovideoscope
Product code: FDF Colonoscope And Accessories, Flexible/Rigid
Reason for recall: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On October 16, 2023, the firm notified affected customers through URGENT MEDICAL DEVICE REMOVAL letters. Customers were instructed to inspect their inventory and identify affected devices. Affected devices should be quarantined and not used. Olympus Customer Solutions will contact customers by phone and email to arrange the return and repair of the affected product. If you require additional information, please do not hesitate to contact Olympus at 647-999-3203 or [email protected].
Quantity in commerce: 24 incorrectly repaired units
Distribution: Domestic distribution to FL, KY, MA, NJ, NY, and PA
Product codes and lots: UDI-DI 04953170305115 Serial Numbers 2635812, 2416423

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0415-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0415-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-06	2023-11-29
Z-0416-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-06	2023-11-29
Z-0417-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-06	2023-11-29
Z-0418-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-06	2023-11-29
Z-0419-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-06	2023-11-29

Product code FDF

K131780Class IIEvis Exera III Video SystemOlympus Medical Systems Corp. / cleared 2013-08-29

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)