Intuitive Surgical, Inc. EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories fo Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories fo
Brand
Intuitive Surgical, Inc.
Lot Codes / Batch Numbers
EndoWrist Stapler 45 instrument, Model Number: IS3000 Part Number: PN 410298-06, -07, -08, -09 All Lots.
Products Sold
EndoWrist Stapler 45 instrument, Model Number: IS3000 Part Number: PN 410298-06, -07, -08, -09 All Lots.
Intuitive Surgical, Inc. is recalling EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product U due to Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due to reports of inability to remove the st. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due to reports of inability to remove the stapler from tissue.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026