Z-2046-2026Class II

Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number...

Name: Z-2046-2026 Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number...
Creator: Intuitive Surgical, Inc.
Published: 2026-04-02
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2026-04-02 / Open, Classified / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product... on 2026-04-02. FDA classified it as Class II and gives the reason as "Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking". 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-2046-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-02
Posted: 2026-05-01
Recalling firm: Intuitive Surgical, Inc.
Product: Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 04/02/2026, the firm sent via 2-day mailing service an "Urgent Medical Device Correction" letter to customers informing them that Intuitive identified that the screws on the cannula mount of the USM from a specific population are susceptible to breaking over time. When the cannula mount experiences a breakage of all six screws, the mount can separate from the rest of the USM. Breakage of any fewer than six screws will not result in cannula mount separation, or impact to clinical performance. How to recognize issue/failure: Screw breakage or cannula mount loosening may be observable as visible or tactile separation of the cannula mount from the body of the USM. Prior to a procedure, closely inspect the joint between the cannula mount and insertion axis that is joined by the screws in Figure 1 in the Urgent Medical Device Correction Letter. Manipulate the cannula mount joint by hand to ensure there is no movement or looseness. If looseness or separation is observed, discontinue use of the USM and contact representative to schedule a site visit. If all six screws were to break intra-operatively, the user may also observe imprecise or unintended instrument tip motion. If observed imprecise or unintended instrument tip motion, inspect the cannula mount for looseness or separation and if present, discontinue use of the USM and contact representative to schedule a site visit. Customers are instructed to: 1. This notice needs to be passed on to all those who need to be aware within your organization or functions where the potentially affected devices have been transferred. 2. Retain a copy of letter, place with your affected system, and keep a copy of the acknowledgement form for your files. For Questions: North/South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: [email protected]. Europe/Middle East/Asia/Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or [email protected] South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or support
Quantity in commerce: 2781
Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Malta, Mexico, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
Product codes and lots: Lot Code: UDI: 00886874114216 FDA Medical Device Listing Number: D531324 See attachment Affected Product List UDI: 00886874114216 FDA Medical Device Listing Number: D295931 See attachment Affected Product List

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2046-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2046-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01

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)