EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci… — Class II medical device recall Z-1568-2016
Terminated recall by Intuitive Surgical, Inc., reported 2016-05-04, distributed nationwide. Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to
| Recall number | Z-1568-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2016-03-25 |
| Classified | 2016-04-26 |
| Reported by FDA | 2016-05-04 |
| Terminated | 2016-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 43 |
| Reason classes | software |
| Serial numbers | SK0036, SK0039, SK0057, SK0101, SK0106, SK0119, SK0143, SK0144, SK0146, SK0171, SK0173, SK0181, SK0216, SK0230, SK0233, SK0237, SK0238, SK0263, SK0286, SK0291, SK0292, SK0293, SK0294, SK0326, SK0358 and 25 more |
| Model numbers | IS4000 |
Product
EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.
Reason for recall
Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly transitioning from the clamp to the fire pedal during use.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.