Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT

Class I - Dangerous
🏥 Medical Devices Recalled: February 14, 2024 Covidien Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Model Number: SIGSDS30CTVT; UDI/DI: 10884521741881; Lot number: N3L1909UY;
  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:
Covidien, LP
Reason for Recall:
Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT

Product Codes/Lot Numbers:

Model Number: SIGSDS30CTVT; UDI/DI: 10884521741881; Lot number: N3L1909UY;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1457-2024

Related Recalls

Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting

Jun 23, 2025 Diagnostic Equipment Nationwide View Details →