Recall archive / FDA device enforcement
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE — FDA record Z-0418-2024
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 Oct 16, 2023. 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
- PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
- Reason
- Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
- Classification
- Class II
- Recalling firm
- Aizu Olympus Co., Ltd.
- Quantity
- 24 incorrectly repaired units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0418-2024
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 | UDI-DI 04953170363672 Serial Numbers 2942716, 2604497, 2502056 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic distribution to FL, KY, MA, NJ, NY, and PA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 6, 2023
- Recall initiation date
- Oct 16, 2023
- Center classification date
- Nov 29, 2023
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.