Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0714-2025 — Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.

U.S. FDA — Device Enforcement · Germany · 2024-11-27 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0714-2025
Date of alert
2024-11-27
Country / jurisdiction
Germany
Risk level
Class I
Risk type
recall
Brand
Trokamed GmbH
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04251303810919
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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