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U.S. Department of Health and Human Services

Class 2 Device Recall Da Vinci SP Instrument Arm Drape

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 Class 2 Device Recall Da Vinci SP Instrument Arm Drapesee related information
Date Initiated by FirmMay 12, 2025
Date PostedJuly 10, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2722-2026
Recall Event ID 98890
510(K)NumberK173906 K182371 
Product Classification System, surgical, computer controlled instrument - Product Code NAY
Productda Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Code Information UDI-DI: 00886874113486, Lot: 3074LA0500, 1124LA0200, 2124LA0400, 1134LA0700, 1144LA0500, 7154LA0200, 6164LA0800, 1084LA0300, 3164LAA800, 4084LA0500, 4124LA0600, 1274LA0500, 2294LA0200, 1274LA0400, 4284LA0800, 6324LA0200, 1324LA0300, 4154LA0400, 2284LA0100, 4144LA1300, 3324LA0500, 2354LA0500, 7144LA0500, 4294LA0700, 3374LA0400, 5264LA0700, 3224LA0500, 3424LA0200, 1394LA0100
FEI Number 3001675293
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd
Sunnyvale CA 94086-5304
For Additional Information ContactShahbaz Khan
408-523-2443
Manufacturer Reason
for Recall		Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall.
FDA Determined
Cause 2		Process control
ActionOn 5/12/2025, correction notices were emailed to customers informing them of the following: 1) Conduct pre-use inspection steps outlined prior to each procedure, see below. 2) If you encounter a drape that does not pass the inspection steps, contact firm customer service. 3) Complete and return the acknowledgement form via email to Recalls@intusurg.com or EU.fsca@intusurg.com If you need further information or support concerning this Safety Notice, please contact your Clinical Sales Representative or contact firm Customer Service at the numbers listed below: - North and South America: (800) 876-1310, Option 3 or mail: customerservice@intusurg.com. - Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 or eucs@intusurg.com - South Korea: 02-3271-3200or support.korea@intusurg.com - Japan: 0120-56-5635 or 03-5575-1362 or csjapan@intusurg.com " Taiwan: +0800-86-8181 Pre-Use Inspection Steps: 1. Fully drape the da Vinci SP system according to user manual. 2. Press and hold the Instrument Arm Clutch button. Top Instrument arm clutch, not recommended. 3. While holding the Instrument Arm Clutch button, manually rotate the instrument drive cluster in one direction, 360-degrees. Then, rotate the instrument drive at least 360-degrees in the other direction. Stop immediately and press "deploy for draping" again to rehome the instrument drive cluster to replace the drape if you observe any of the following behaviors: a. Inability to rotate the instrument drive 360-degrees in both directions b. VSC message that drape is not fully attached (VSC message: "Check drape is secure to all 4 instrument arm clips" or "Insecure or missing drape. The drape may not be properly secured and could fall. Ensure the drape is properly connected to all 4 mounts to continue"). c. Drape outer ring falls off silver section of system. d. Any of the 4 dark gray marks disengage from the dark gray connectors during the rotation.
Quantity in Commerce11113
DistributionWorldwide - US Nationwide distribution in the states of NJ, OR, NY, FL, AL, SD, TX, VA, WV, PA, CA, WA, CT, MA, IL, OK, OH, MI, NC, MO, KY, WI, AZ, CO, GA, MD, SC, IN, NV, TN, MS, KS, IA, UT, MN, LA, NE, ME and the countries of Germany, Sweden, United Kingdom, Italy, Belgium, Switzerland, Denmark, Japan, South Korea, Hong Kong, Taiwan, France, Ireland, Spain.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NAY
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