Sheath — Class I medical device recall Z-0714-2025
Ongoing recall by Trokamed GmbH, reported 2025-01-22. If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fr
| Recall number | Z-0714-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trokamed GmbH, Geisingen, Germany |
| Recall initiated | 2024-11-27 |
| Classified | 2025-01-10 |
| Reported by FDA | 2025-01-22 |
| Countries outside the US | DE |
| Quantity | 42 units |
| Reason classes | foreign material |
| UPC / GTIN / UDI-DI | 04251303810919 |
| Lot numbers | 154236 |
| Model numbers | WA2PS20L |
Product
Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0714-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.