Olympus Corporation of the Americas Colonovideoscope Model CF-H180AL Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Colonovideoscope Model CF-H180AL
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
UDI-DI: 04953170339615 Serial number: 2501131
Products Sold
UDI-DI: 04953170339615 Serial number: 2501131
Olympus Corporation of the Americas is recalling Colonovideoscope Model CF-H180AL due to 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 nor. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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 Cynthia.Ow@Olympus.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026