da Vinci Surgical System Patient Cart Ballscrew Failure Risk
Intuitive Surgical recalls Patient Side Carts for da Vinci X and Xi surgical systems due to ballscrew failure risk. The failure could cause uncontrolled carriage movement leading to potential tissue injury during surgery. 9 units affected.
What this means for you
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 is a Class II FDA recall of surgical equipment with identified risk of patient tissue injury from mechanical failure. No injuries have been reported, and the hazard remains theoretical despite the identified risk. Per the rubric, risk-of-harm medical devices without reported injury are scored as High (3).
Plain-English summary
Intuitive Surgical, Inc. is recalling Patient Side Carts (REF 380620 for da Vinci X systems and REF 380652 for da Vinci Xi systems). These components are part of surgical robotic systems used to assist surgeons in performing surgical procedures.
Preventative maintenance data identified instrument arms at risk of insertion ballscrew failure. If this failure occurs, the carriage could move uncontrollably along the insertion axis, potentially causing tissue injury to patients.
Nine units have been distributed worldwide, with US distribution in Florida, Georgia, and Washington, as well as international distribution in the United Kingdom, Germany, and France.
Healthcare facilities and surgeons using affected da Vinci systems should contact Intuitive Surgical for instructions regarding the recall. Specific serial numbers and system identifiers are available from the FDA recall notice for identifying affected equipment.
The recalled product
- Product
- Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- ballscrew-failure
- uncontrolled-movement
- tissue-injury
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 (14)
- System REF: Serial Numbers/Cart REF/UDI-DI/Arm Serial Numbers: IS4200: SL0379
- SL0069/ 380620/ 00886874115404/ 668080
- 575093
- IS4000: SK1402
- SK0991
- SK2332
- SK0744
- SK0110
- SK0753/380652 / 00886874110720/ 372054
- 663693
- 557322
- 547953
- 425439
- 409962
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03