Z-1274-2022Class II

Colonovideoscope Model CF-H180AL

Name: Z-1274-2022 Colonovideoscope Model CF-H180AL
Creator: Olympus Corporation of the Americas
Published: 2022-04-22
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2022-04-22 / Terminated / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of Colonovideoscope Model CF-H180AL on 2022-04-22. FDA classified it as Class II and gives the reason as "A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1274-2022
Classification: Class II
Status: Terminated
Initiated: 2022-04-22
Posted: 2022-06-21
Terminated: 2024-03-13
Recalling firm: OLYMPUS Corporation of the Americas
Product: Colonovideoscope Model CF-H180AL
Product code: FDF Colonoscope And Accessories, Flexible/Rigid
Reason for recall: A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out (approximately 1.4 mm) further than normal protrusion,could lead to patient injury; specifically, mucosal damage that could result in hemorrhage or bleeding
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Olympus issued letter via e-mail on April 22, 2022. Letter states reason for recall, health risk and action to take: 1. Identify the affected model and serial number in the subject of this letter. 2. An Olympus representative will contact you to arrange for the return of your affected device. Olympus will repair your unit free of charge. 3. Olympus will provide a service loaner device in an effort to not disrupt patient care. Contact: 647-999-3203 or at [email protected]
Quantity in commerce: 1 unit
Distribution: US Nationwide distribution in the state of KY.
Product codes and lots: UDI-DI: 04953170339615 Serial number: 2501131

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1274-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1274-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-29	2022-06-21

Product code FDF

K100584Class IIEvis Exeraii 180 SystemOlympus Medical Systems Corporation / cleared 2010-07-02

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)