Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System
Medical device recall Z-0436-2014. Published in FDA’s Enforcement Report on Dec 11, 2013.
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 Dec 11, 2013. 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
- 1,386 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?
Reports of friction within certain instrument arms can interrupt smooth instrument motion. This can be felt by the surgeon as resistance in the movement of the master.In this situation, the instrument can stall momentarily and then suddenly catch-up to the master position if the surgeon pushes through the resistance.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System; da Vinci SI Surgical System da Vinci Si-e Surgical System; Manufactured by Intuitive Surgical Sunnyvale, CA 94086. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS2000/3000) 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, electro cautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electro cautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general cardiovascular and non-cardiovascular thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system is indicated for adult and pediatric use
1,386, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Part number 380900-02 and 380900-03: System ID numbers - US: SH0018 SH0206 SH0407 SH0752 SH0981 SH1179 SH1417 SH1690 SH1785 SH1887 SH0022 SH0214 SH0408 SH0755 SH0983 SH1180 SH1418 SH1699 SH1786 SH1889 SH0025 SH0216 SH0409 SH0756 SH0987…
Every code shown here, 2,000 characters
Part number 380900-02 and 380900-03: System ID numbers - US: SH0018 SH0206 SH0407 SH0752 SH0981 SH1179 SH1417 SH1690 SH1785 SH1887 SH0022 SH0214 SH0408 SH0755 SH0983 SH1180 SH1418 SH1699 SH1786 SH1889 SH0025 SH0216 SH0409 SH0756 SH0987 SH1186 SH1430 SH1706 SH1787 SH1890 SH0030 SH0223 SH0414 SH0762 SH0989 SH1191 SH1437 SH1707 SH1789 SH1891 SH0032 SH0226 SH0423 SH0765 SH0994 SH1194 SH1441 SH1709 SH1790 SH1892 SH0036 SH0228 SH0427 SH0769 SH0997 SH1199 SH1445 SH1710 SH1791 SH1893 SH0038 SH0232 SH0428 SH0770 SH1007 SH1201 SH1448 SH1711 SH1792 SH1894 SH0040 SH0240 SH0431 SH0772 SH1011 SH1203 SH1459 SH1719 SH1793 SH1896 SH0042 SH0243 SH0436 SH0781 SH1012 SH1215 SH1461 SH1721 SH1794 SH1897 SH0049 SH0245 SH0437 SH0791 SH1013 SH1246 SH1507 SH1727 SH1795 SH1899 SH0053 SH0248 SH0438 SH0808 SH1014 SH1259 SH1517 SH1728 SH1797 SH1900 SH0055 SH0254 SH0439 SH0819 SH1016 SH1269 SH1518 SH1729 SH1798 SH1903 SH0057 SH0258 SH0448 SH0821 SH1024 SH1269 SH1531 SH1731 SH1808 SH1904 SH0060 SH0262 SH0453 SH0823 SH1027 SH1273 SH1539 SH1733 SH1809 SH1905 SH0065 SH0265 SH0454 SH0829 SH1029 SH1283 SH1564 SH1735 SH1810 SH1906 SH0066 SH0266 SH0466 SH0838 SH1030 SH1285 SH1580 SH1736 SH1811 SH1907 SH0067 SH0268 SH0473 SH0845 SH1031 SH1286 SH1581 SH1739 SH1812 SH1908 SH0068 SH0272 SH0475 SH0847 SH1032 SH1288 SH1583 SH1741 SH1814 SH1909 SH0070 SH0275 SH0489 SH0849 SH1034 SH1290 SH1589 SH1743 SH1815 SH1910 SH0076 SH0282 SH0490 SH0850 SH1036 SH1293 SH1594 SH1744 SH1817 SH1912 SH0078 SH0284 SH0493 SH0853 SH1050 SH1294 SH1598 SH1746 SH1822 SH1913 SH0082 SH0292 SH0521 SH0855 SH1053 SH1306 SH1599 SH1747 SH1823 SH1915 SH0085 SH0296 SH0524 SH0858 SH1055 SH1322 SH1605 SH1748 SH1824 SH1916 SH0108 SH0304 SH0525 SH0862 SH1059 SH1324 SH1606 SH1749 SH1827 SH1922 SH0112 SH0309 SH0527 SH0865 SH1069 SH1331 SH1612 SH1750 SH1831 SH1923 SH0113 SH0310 SH0543 SH0866 SH1080 SH1332 SH1617 SH1752 SH1840 SH1924 SH0115 SH0314 SH0548 SH0867 SH1081 SH1333 SH1629 SH1753 SH1841 SH1925 SH0134 SH0318 SH0557 SH0871 SH1082 SH1334 SH1630…
FDA’s list runs to 5,723 characters. The first part is shown; the rest is on FDA’s record.
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 to countries of: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Denmark, France, Germany, India, Israel, Italy, Japan, S. Korea, Luxembourg, Mexico, Monaco, Netherlands, Norway, Romania. Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
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 Nov 11, 2013.
- FDA classified it on Dec 3, 2013.
- FDA’s Enforcement Report published it on Dec 11, 2013.
- FDA terminated it on Feb 18, 2014.
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.”
- FDA’s list of codes runs to 5,723 characters; the first part is shown here, and the rest is on FDA’s record.
- 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
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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.