Trokamed recalls 18Fr gastroenterology-urology endoscopic access overtubes with risk of kidney pressure buildup from fast inflow. Affected units have REF WA2PS18S and Lot 159825.
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 tube used in medical procedures. If the inflow speed is too fast, it could cause dangerous buildup of pressure inside the kidney, potentially leading to injury.
If the inflow speed is too quick, blood, tissue fragments, and kidney stones can block the tube's outflow. This causes pressure to build up inside the kidney, which could lead to injury.
Medical professionals using this specific endoscopic access tube for procedures involving the gastrointestinal or urinary tract. Patients undergoing procedures with this device are at risk if the device is used incorrectly.
Check for the reference number WA2PS18S on the device. The lot number 15982: 159825 is also associated with this recall. This device is used in gastroenterology and urology procedures.
Look for the reference number WA2PS18S on the device label.
The recall states the hazard occurs only if inflow speed is too quick, so it's safe when used properly.
The recall record doesn't specify a remedy, so contact Trokamed directly for guidance.
Check for reference number WA2PS18S and lot number 159825 on the device.
We’ve drafted a message you can send Trokamed to request your refund or repair — edit it as you like.
Subject: Recall Z-0715-2025 — Trokamed Trokamed Hello, I own a Trokamed that is covered by recall Z-0715-2025 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.