da Vinci Xi Surgical System P4 software;with Xi Stapler
Medical device recall Z-2734-2015. Published in FDA’s Enforcement Report on Sep 9, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 9, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 198 affected devices how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System P4 version software.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General and Plastic 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 thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures.
198 affected devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model number IS4000; Affected da Vinci Xi Surgical System Serial Numbers SK0036 SK0076 SK0119 SK0156 SK0198 SK0250 SK0288 SK0342 SK0395 SK0425 SK0039 SK0077 SK0120 SK0157 SK0203 SK0254 SK0289 SK0346 SK0398 SK0433 SK0046 SK0079 SK0122…
Every code shown here, 1,445 characters
Model number IS4000; Affected da Vinci Xi Surgical System Serial Numbers SK0036 SK0076 SK0119 SK0156 SK0198 SK0250 SK0288 SK0342 SK0395 SK0425 SK0039 SK0077 SK0120 SK0157 SK0203 SK0254 SK0289 SK0346 SK0398 SK0433 SK0046 SK0079 SK0122 SK0159 SK0206 SK0255 SK0291 SK0347 SK0399 SK0434 SK0047 SK0081 SK0123 SK0160 SK0209 SK0257 SK0292 SK0352 SK0400 SK0437 SK0048 SK0087 SK0127 SK0161 SK0211 SK0259 SK0293 SK0356 SK0401 SK0440 SK0049 SK0091 SK0130 SK0162 SK0212 SK0262 SK0294 SK0358 SK0402 SK0441 SK0051 SK0092 SK0134 SK0163 SK0216 SK0263 SK0296 SK0359 SK0404 SK0443 SK0054 SK0093 SK0135 SK0167 SK0225 SK0264 SK0297 SK0360 SK0406 SK0445 SK0057 SK0095 SK0137 SK0168 SK0229 SK0265 SK0298 SK0366 SK0408 SK0448 SK0058 SK0096 SK0138 SK0169 SK0231 SK0266 SK0299 SK0371 SK0409 SK0451 SK0059 SK0098 SK0139 SK0171 SK0233 SK0267 SK0301 SK0375 SK0410 SK0452 SK0061 SK0099 SK0143 SK0173 SK0234 SK0269 SK0302 SK0376 SK0412 SK0455 SK0062 SK0100 SK0144 SK0175 SK0235 SK0270 SK0304 SK0378 SK0414 SK0456 SK0066 SK0101 SK0145 SK0176 SK0236 SK0271 SK0307 SK0382 SK0415 SK0459 SK0067 SK0103 SK0146 SK0178 SK0237 SK0275 SK0309 SK0383 SK0416 SK0463 SK0069 SK0106 SK0147 SK0179 SK0238 SK0276 SK0310 SK0384 SK0417 SK0464 SK0070 SK0113 SK0148 SK0180 SK0239 SK0277 SK0311 SK0385 SK0418 SK0071 SK0114 SK0150 SK0181 SK0242 SK0284 SK0314 SK0389 SK0420 SK0072 SK0115 SK0151 SK0186 SK0243 SK0285 SK0316 SK0390 SK0422 SK0074 SK0116 SK0153 SK0193 SK0245 SK0286 SK0317 SK0394 SK0423.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US Nationwide and in the countries of Italy and Norway.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 17, 2015.
- FDA classified it on Sep 3, 2015.
- FDA’s Enforcement Report published it on Sep 9, 2015.
- FDA terminated it on Feb 8, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Intuitive Surgical, Inc., of Sunnyvale, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.