Trokamed recalls gastroenterology-urology endoscopic access overtubes with model WA2PS20L due to potential kidney pressure buildup from rapid blood flow. Affected units have specific lot numbers and UDI-DI codes.
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.
Trokamed is recalling a specific type of endoscopic access overtube (model WA2PS20L) because it can cause dangerous kidney pressure buildup if blood flows too quickly through it. This could lead to serious injury if not addressed.
If blood, tissue fragments, or kidney stones flow too quickly through the overtube, it can block the outflow path. This causes pressure to build up inside the kidney, potentially leading to injury.
Healthcare professionals using this overtube for procedures involving the urinary tract or gastrointestinal system are most at risk. Patients undergoing such procedures with this specific model may also be affected.
Check for the model number WA2PS20L on the product. Affected units have lot numbers starting with 154236 and UDI-DI code 04251303810919.
Look for the model number WA2PS20L, lot numbers starting with 154236, and UDI-DI code 04251303810919 on the product.
The recall states the hazard occurs only if inflow speed is too quick, so it may be safe with proper use. However, the manufacturer recommends checking for affected units.
Check for the model number WA2PS20L, lot numbers starting with 154236, and UDI-DI code 04251303810919 on the product.
The recall does not specify a remedy, so contact Trokamed directly for guidance on next steps.
We’ve drafted a message you can send Trokamed to request your refund or repair — edit it as you like.
Subject: Recall Z-0714-2025 — Trokamed Trokamed Hello, I own a Trokamed that is covered by recall Z-0714-2025 from Trokamed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.