Recall archive / FDA device enforcement
Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube. — FDA record Z-0715-2025
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 Nov 27, 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
- Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
- Reason
- If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
- Classification
- Class I
- Recalling firm
- Trokamed GmbH
- Quantity
- 53 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0715-2025
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 | REF: WA2PS18S; UDI-DI: 04251303810865; Lot Numbers: 159825 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .
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
- Jan 22, 2025
- Recall initiation date
- Nov 27, 2024
- Center classification date
- Jan 10, 2025
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.