Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments
Intuitive Surgical is recalling 875 da Vinci EndoWrist Stapler 30 instruments due to reported field failures involving shaft rotation interruption or jaws not opening.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects in high-risk medical devices, are classified as Severe (4).
Plain-English summary
Intuitive Surgical, Inc. is recalling 875 units of the da Vinci EndoWrist Stapler 30 Instrument (Model 470430). These instruments are intended for use with the da Vinci Xi Surgical System (Model IS4000) for resection, transection, and creation of anastomoses in general, thoracic, gynecologic, and urologic surgery. The recall covers 827 instruments sold individually and 48 included in kits.
The recall was initiated due to reported field failures where the instruments experienced an interruption in shaft rotation and/or the instrument jaws failed to open. The affected devices were distributed worldwide, including nationwide in the United States and internationally to Australia, Belgium, Denmark, France, Germany, Italy, Japan, Spain, Sweden, Switzerland, Taiwan, and Turkey.
Healthcare providers and facilities using these instruments should stop using the affected model immediately and contact Intuitive Surgical for further instructions on the recall process.
The recalled product
- Product
- STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: 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…
- Manufacturer
- Intuitive Surgical, Inc.
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 model 470430
Distribution
Distributed nationwide across the United States.
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 · mechanical failure
See all →- ModerateMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- HighMedline surgical kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Kits With Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- HighBaxter Recalls Likorall Overhead Lifts Due to Motor Shaft Breakage Risk
FDA (Devices) · 2026-10-21
Similar recalls
- HighIntuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments
FDA (Devices) · 2016-08-17
- ModerateIntuitive Surgical Recalls da Vinci Xi EndoWrist Stapler 45 Instruments
FDA (Devices) · 2018-01-31
- SevereIntuitive Surgical Recalls EndoWrist Stapler 45 Instruments
FDA (Devices) · 2014-10-22
- HighIntuitive Surgical da Vinci EndoWrist Stapler 45 Recall for Firing Failures
FDA (Devices) · 2016-08-17
- ModerateIntuitive Surgical Recalls da Vinci Xi EndoWrist Stapler Release Kits
FDA (Devices) · 2017-04-12
- HighIntuitive Surgical Recalls da Vinci Xi Stapler Instruments Due to Motion Risk
FDA (Devices) · 2016-05-04