🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: November 27, 2024 Trokamed GmbH Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    REF: WA2PS18L; UDI-DI: 04251303810872; Lot Numbers: 154214
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Trokamed GmbH
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Distribution:

Distributed in: US, PA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0716-2025

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