da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Summary
The FDA issued a Class II for da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15 by Intuitive Surgical, Inc.. Reason: 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 pro.
Details
Source
Device Recall
External ID
Z-2722-2026
Action Date
2026-07-22
Status
Ongoing
Category
device
Product Description
da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Lot/Code Info: 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
Quantity Affected: 11113
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.
Distribution
Worldwide - 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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-12
Company
Sunnyvale, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 102 device recalls issued in the same week, part of 365 device-related FDA actions this month.
Intuitive Surgical, Inc. has 124 FDA actions in our database, including 75 recalls and 49 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Intuitive Surgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Intuitive Surgical, Inc. have FDA actions?
Intuitive Surgical, Inc. has 124 FDA actions in our database, including 75 recalls and 49 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2722-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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