🔍 RecallPedia

da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch

Class I - Dangerous
🏥 Medical Devices Recalled: October 25, 2018 Intuitive Surgical Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Model Number: 430013-12 UDI Number: 00886874113486 Lot Numbers: 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:
The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
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 SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch

Product Codes/Lot Numbers:

Model Number: 430013-12 UDI Number: 00886874113486 Lot Numbers: All Lots

Distribution:

Distributed in: FL, OH, TN, NJ, PA, MD, NY, CA, MN, NV, OR, HI, VA, TX, AL, IL, CN, NC

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1906-2020

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