EVIS EXERA II COLONOVIDEOSCOPE recallZ-1274-2022 · Olympus Corporation of the Americas · initiated Apr 22, 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 Olympus Corporation of the Americas 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
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
FDA root cause category: Nonconforming Material/Component
What the company is doing
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]
Recall details
- Recall number
- Z-1274-2022
- Status
- Terminated
- Initiated by the company
- Apr 22, 2022
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 1 unit
- Product code
- FDF
- FDA submissions
- K100584
- Distribution
- US Nationwide distribution in the state of KY.
Product description
Colonovideoscope Model CF-H180AL
Code information (models, lots, serial numbers)
UDI-DI: 04953170339615 Serial number: 2501131
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180ALOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid1 recall323 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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