Class I — Trokamed GmbH
| Recalling firm | TROKAMED GMBH |
|---|---|
| Registered facility | TROKAMED GMBH (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| 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. |
| Product | Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube. |
| Quantity | 42 units |
| Distribution | US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. . |
| Initiated | 2024-11-27 |
| Classified | 2025-01-10 |
| Recall number | Z-0714-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Trokamed GmbH (Z-0714-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95770/
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