Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch Recalled by Intuitive Surgical, Inc. Due to The instrument drape may tear while draping the...

Date: October 25, 2018
Company: Intuitive Surgical, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Intuitive Surgical, Inc. directly.

Affected Products

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

Quantity: 1818 pouches

Why Was This Recalled?

The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.

Where Was This Sold?

This product was distributed to 17 states: AL, CA, FL, HI, IL, MD, MN, NV, NJ, NY, NC, OH, OR, PA, TN, TX, VA

Affected (17 states)Not affected

About Intuitive Surgical, Inc.

Intuitive Surgical, Inc. has 244 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report