Da Vinci Surgical Clip Appliers Recalled for Potential Unexpected Motion
Intuitive Surgical is recalling three models of Da Vinci clip appliers due to potential unexpected motion from partial instrument disengagement. Approximately 90,628 units have been distributed worldwide.
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: This FDA Class II recall involves a surgical instrument with potential for unexpected motion due to mechanical disengagement. While no injuries or illnesses are reported in the source, the hazard represents a risk-of-harm to patients during instrument use, meeting the rubric criterion for High severity.
Plain-English summary
Intuitive Surgical, Inc. is recalling Da Vinci X/Xi surgical clip appliers (Large Model 470230, Medium-Large Model 470327, and Small Model 470401) due to the potential for unexpected motion caused by partial disengagement of the instrument from the system.
Approximately 90,628 clip appliers have been distributed worldwide, including throughout the United States and internationally to countries including Canada, Mexico, Japan, Germany, the United Kingdom, Australia, and many others.
Affected parties should contact Intuitive Surgical for instructions regarding the recalled devices. Healthcare facilities should immediately verify whether they have received any of the affected models and follow the manufacturer's guidance.
The recalled product
- Product
- Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Small Clip Applier, Model 47401
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 90,628
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 · unexpected motion
See all →- HighCT Scanner Software Upgrade May Cause Unexpected Table Movement
FDA (Devices) · 2024-04-17
- HighIBA Proton Therapy System Patient Positioning Can Move Unexpectedly
FDA (Devices) · 2023-11-22
- HighDa Vinci Clip Applier Recall: Risk of Unexpected Instrument Motion
FDA (Devices) · 2022-08-03
- HighMobile X-Ray System Recalled for Unexpected Column Motion During Parking
FDA (Devices) · 2021-10-06
- Severe
Similar recalls
- HighIntuitive Surgical Recalls da Vinci Si Single-Site Clip Appliers
FDA (Devices) · 2015-09-16
- HighIntuitive Surgical Recalls 8mm Clip Appliers Due to Reprocessing Deviations
FDA (Devices) · 2014-12-03
- HighIntuitive Surgical Recalls Large Clip Applier Instruments Due to Jamming Risk
FDA (Devices) · 2014-07-16
- HighFDA Recalls Small Graptor Retractor Instruments Due to Cable Failures
FDA (Devices) · 2025-01-22
- HighIntuitive Da Vinci Stapler Instruments Recalled for Potential Staple Deployment Failure
FDA (Devices) · 2022-12-07
- HighIntuitive Surgical Recalls 8mm Large Hem-O-Lok Clip Applier Devices
FDA (Devices) · 2014-12-03