🔍 RecallPedia

da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.

Class I - Dangerous
🏥 Medical Devices Recalled: April 23, 2018 Intuitive Surgical Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    UDI: 00886874112878. Device expiration: 10/14/2017 02/21/2020
  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:
Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.

Product Codes/Lot Numbers:

UDI: 00886874112878. Device expiration: 10/14/2017 02/21/2020

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2380-2018

Related Recalls