Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments
Intuitive Surgical is recalling da Vinci EndoWrist Stapler 30 instruments and reloads due to an increased trend of 'Stapler Firing Failed' messages.
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 involves a surgical instrument with a functional failure (firing failure) that poses a risk of harm during surgery, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling the da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads, model number 470430. These devices are intended for use with the da Vinci Xi Surgical System (Model IS4000) for resection, transection, and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The recall covers 2,065 units distributed in the United States, Puerto Rico, Australia, and various countries in Europe, Asia, and South America.
The recall was initiated due to an increase in customer complaints reporting a 'Stapler Firing Failed' message. A review of da Vinci Xi Surgical System logs confirmed an increased trend of these failures. The source text does not report any specific injuries, illnesses, or deaths associated with these events.
Healthcare facilities and distributors should stop using the affected devices and contact Intuitive Surgical for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of…
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 2,065
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)
- All
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 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 3 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 failure
See all →- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
Similar recalls
- SevereIntuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments
FDA (Devices) · 2016-09-07
- SevereIntuitive Surgical da Vinci EndoWrist Stapler 45 Recall for Field Failures
FDA (Devices) · 2016-09-07
- ModerateIntuitive Surgical Recalls da Vinci Xi EndoWrist Stapler 45 Instruments
FDA (Devices) · 2018-01-31
- ModerateIntuitive Surgical Recalls da Vinci Xi EndoWrist Stapler Release Kits
FDA (Devices) · 2017-04-12
- ModerateIntuitive Surgical Recalls da Vinci Xi Stapler Release Kits Due to Instruction Issues
FDA (Devices) · 2017-04-12
- ModerateIntuitive Surgical Recalls da Vinci Xi Stapler Release Kits
FDA (Devices) · 2017-04-12