FDA Device Recall Z-0713-2025

Trokamed GmbH

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.

Lot / serial / GTIN: REF: WA2PS20S; UDI-DI: 04251303810926; Lot Numbers: 154125

Quantity: 34 units

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.

Recall record

Recall number: Z-0713-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .
Recall initiated: 2024-11-27
Classified by FDA Center: 2025-01-10
FDA published: 2025-01-22
Recalling firm: Trokamed GmbH

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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