Recall archive / FDA device enforcement
Colonoscope, Model Number PCF-H190L. — FDA record Z-1211-2024
Reported ongoing
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 Jan 11, 2024. 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
- Colonoscope, Model Number PCF-H190L.
- Reason
- Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- Classification
- Class II
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 31
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1211-2024
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 | Model Number: PCF-H190L; UDI DI: 04953170305191; Serial Number: 2201678, 2201735, 2301759, 2301775, 2301929, 2301930, 2302159, 2302280, 2302281, 2302380, 2302506, 2303832, 2303927, 2404124, 2404132, 2404806, 2404888, 2404967, 2405012, 2405253, 2405290, 2405353, 2517013, 2517120, 2517422, 2517440, 2517541, 2517616, 2517649, 2517705, 2628544; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution.
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
- Mar 6, 2024
- Recall initiation date
- Jan 11, 2024
- Center classification date
- Feb 29, 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.