FDA Medical devices recall ·
Sheath, 18 Fr., 160 mm ( recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0716-2025
- Date
- (initiated November 27, 2024)
- Company / brand
- Trokamed GmbH
Kleine Breite 17, Geisingen, Germany - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 102 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF: WA2PS18L; UDI-DI: 04251303810872; Lot Numbers: 154214
Distribution
US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .
States: Pennsylvania
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0716-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.