🔍 RecallPedia

da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12

Class I - Dangerous
🏥 Medical Devices Recalled: June 12, 2023 Intuitive Surgical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 00886874112496, All Lots.
  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:
Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.
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 Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12

Product Codes/Lot Numbers:

UDI-DI: 00886874112496, All Lots.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2059-2023

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