Trokamed GmbH: Medical Device Recall in 2025 - (Recall #: Z-0716-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.

Product Classification:

Class I

Date Initiated: November 27, 2024

Date Posted: January 22, 2025

Recall Number: Z-0716-2025

Event ID: 95770

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.

Status: Ongoing

Product Quantity: 102 units

Code Information:

REF: WA2PS18L; UDI-DI: 04251303810872; Lot Numbers: 154214

Distribution Pattern:

US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .

Voluntary or Mandated:

Voluntary: Firm initiated