🔍 RecallPedia

Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm

Class I - Dangerous
🏥 Medical Devices Recalled: October 6, 2023 Intuitive Surgical Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    UDI:00886874113752/ Serial Numbers: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109
  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:
Intuitive Surgical, Inc.
Reason for Recall:
There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm

Product Codes/Lot Numbers:

UDI:00886874113752/ Serial Numbers: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109

Distribution:

Distributed in: US, IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0406-2024

Related Recalls