Z-2722-2026Class II

da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15

Name: Z-2722-2026 da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Creator: Intuitive Surgical, Inc.
Published: 2025-05-12
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2025-05-12 / Open, Classified / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15 on 2025-05-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2722-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-12
Posted: 2026-07-10
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Product code: NAY System, Surgical, Computer Controlled Instrument
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 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 [email protected] or [email protected] 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: [email protected]. - Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 or [email protected] - South Korea: 02-3271-3200or [email protected] - Japan: 0120-56-5635 or 03-5575-1362 or [email protected] " 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 commerce: 11113
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2722-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2722-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10

Product code NAY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)