🔍 RecallPedia

EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012

Class I - Dangerous
🏥 Medical Devices Recalled: April 1, 2024 Cook Medical Incorporated Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Catalogue Number: ECHO-HD-19-A; GPN: G52012; UDI/DI: 00827002520127; Lot Numbers: C2145003 and C2144407.
  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:
Cook Medical Incorporated
Reason for Recall:
Devices may contain elevated levels of bacterial endotoxin.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012

Product Codes/Lot Numbers:

Catalogue Number: ECHO-HD-19-A; GPN: G52012; UDI/DI: 00827002520127; Lot Numbers: C2145003 and C2144407.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1832-2024

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Cook Medical Incorporated

Class I - Dangerous

Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.

Sep 18, 2025 Other Medical Devices Nationwide View Details →