Intuitive Surgical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1906-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 25, 2018

Date Posted: May 13, 2020

Recall Number: Z-1906-2020

Event ID: 83503

Reason for Recall:

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

Status: Terminated

Product Quantity: 1818 pouches

Code Information:

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

Distribution Pattern:

Updated information provided on 03/18/2020: FL, OH, TN, NJ, PA, MD, NY, CA, MN, NV, OR, HI, VA, TX, AL, CA, IL, CN, and NC. OUS: APAC (Asia Pacific) - South Korea

Voluntary or Mandated:

Voluntary: Firm initiated