Recall archive / FDA device enforcement
Colonovideoscope Model CF-H180AL — FDA record Z-1274-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 22, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Colonovideoscope Model CF-H180AL
- Reason
- 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
- Classification
- Class II
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 1 unit
- Agency-reported status
- Terminated
- Source record identifier
- Z-1274-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 04953170339615 Serial number: 2501131 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the state of KY.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 29, 2022
- Recall initiation date
- Apr 22, 2022
- Center classification date
- Jun 21, 2022
- Termination date
- Mar 13, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.