Intuitive Surgical Recalls da Vinci X Systems Due to Arm Fault
Intuitive Surgical is recalling 74 da Vinci X Surgical Systems because a manufacturing variation in the arm can cause a fault error and loss of functionality during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a loss of functionality during surgery, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Intuitive Surgical, Inc. is recalling 74 da Vinci X Surgical Systems (Model IS4200) due to a manufacturing variation in the arm. This defect can result in a persistent recoverable fault error (error 23087) and a loss of arm functionality prior to or during surgery.
The affected units were distributed in the United States to California, Maryland, New York, Virginia, Illinois, Michigan, Delaware, Texas, Florida, New Jersey, Massachusetts, Kentucky, and Ohio. The company also distributed units to Australia, France, Germany, and Japan.
Healthcare facilities should contact Intuitive Surgical for instructions on how to resolve the issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- da Vinci X Surgical System
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Surgical Robot
- Affected units
- 74
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model: IS4200 UDI: 00886874114216 Device Listing: D295931
Distribution
Part of a larger recall action
This product is one of 2 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Intuitive Surgical, Inc.
See all →- Moderateda Vinci SP Instrument Arm Drape may detach during surgical procedures
FDA (Devices) · 2026-07-22
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- HighDa Vinci 5 tower may unintentionally activate the infrared handheld camera
FDA (Devices) · 2026-06-10
- Highda Vinci X and Xi Surgical Systems Recalled for Manipulator Arm Screw Breakage
FDA (Devices) · 2026-05-13
- SevereIntuitive 8 mm SureForm 30 Gray Reloads Incomplete Staple Defect
FDA (Devices) · 2026-05-13
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- HighIntuitive Surgical Recalls da Vinci X Systems with Defective Arm Controller Boards
FDA (Devices) · 2018-07-11
- SevereIntuitive Surgical Recalls da Vinci Systems Due to Defective Capacitors
FDA (Devices) · 2020-02-12
- HighIntuitive Surgical Recalls da Vinci X Universal Surgical Manipulators
FDA (Devices) · 2020-05-13
- HighIntuitive Surgical Recalls da Vinci Xi Systems Due to Joint Sensor Fault
FDA (Devices) · 2015-04-01
- HighSurgical robots recalled over a software error hiding failed arm diagnostics
FDA (Devices) · 2026-02-11
- HighIntuitive Surgical Recalls da Vinci Xi Systems Due to Defective Capacitors
FDA (Devices) · 2020-02-12