Z-1906-2020 Class II Terminated
FDA device recall Z-1906-2020 was initiated by Intuitive Surgical, Inc. on Oct 25, 2018 and is designated Class II. Reason for recall: The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier. The recall status is terminated (terminated Apr 5, 2024). Affected quantity: 1818 pouches.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- Oct 25, 2018
- Termination Date
- Apr 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1818 pouches
Product Description
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Reason for Recall
The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
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
Code Information
Model Number: 430013-12 UDI Number: 00886874113486 Lot Numbers: All Lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1906-2020
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026