EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000
Medical device recall Z-0063-2015. Published in FDA’s Enforcement Report on Oct 22, 2014.
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 Oct 22, 2014. 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
- 1,483 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?
Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.
1,483 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Part Number: PN 410322-04, -05 Serial Numbers: SH1484 SH1879 SH1875 SH1485 USG332 SH0561 USG803 SH1406 SH1405 SH0034 SH0554 SH0554 USG160 USG575 SH0908 SH2066 SH1455 SH0975 SH1475 SH1168 SH1552 SH0608 SH0608 SH1756 SH1716 USG071 USG038…
Every code shown here, 2,000 characters
Part Number: PN 410322-04, -05 Serial Numbers: SH1484 SH1879 SH1875 SH1485 USG332 SH0561 USG803 SH1406 SH1405 SH0034 SH0554 SH0554 USG160 USG575 SH0908 SH2066 SH1455 SH0975 SH1475 SH1168 SH1552 SH0608 SH0608 SH1756 SH1716 USG071 USG038 SH0607 SH1590 SH1686 SH1639 SH1688 SH1740 SH1932 USG323 SH1944 USG286 SH1945 SH2022 SH2085 SH1108 SH2047 USG257 USG435 USG183 SH2079 USG035 USG144 USG647 SH1590 USG641 SH0087 USG580 SH0389 USG106 SH1642 USG351 SH0280 SH1963 SH0566 USG551 USG566 USG636 SH2076 USG122 USG163 SH0084 USG706 USG563 SH0252 SH1494 SH1249 SH1588 SH1495 USG103 USG484 SH0329 SH1980 USG060 USG421 USG364 SH0148 USG398 SH0412 SH0881 SH1687 SH2154 SH1998 SH1802 SH1863 SH1939 SH2100 SH2128 SH0572 SH0208 SH1159 SH1592 SH0273 SH2143 SH1297 SH1852 SH2014 SH1941 SH2009 SH2015 SH2013 SH2027 SH2116 SH2056 SH2012 SH2161 SH2193 SH2209 SH0467 SH0238 USG605 SH1962 SH1757 SH1874 SH1938 SH1607 SH1854 SH2096 SH2070 SH2082 SH2095 USG560 USG279 SH1608 USG726 SH1114 SH1614 SH2054 USG116 USG277 USG345 SH2179 SH2207 SH0328 SH1901 SH1940 SH0733 SH0658 SH0062 SH0357 SH1691 SH0893 USG129 SH1565 SH2121 USG418 SH1806 USG127 USG159 USG438 SH1118 SH0030 SH0332 SH0586 SH0819 SH0435 USG445 SH0108 USG156 SH0436 SH0883 SH0950 SH1096 SH1336 SH1369 SH0306 SH0640 SH0481 SH0453 SH1282 SH1177 SH0341 SH0850 SH1192 SH1293 SH0214 SH0319 SH0078 SH0741 SH0949 SH1391 SH1372 SH1322 SH1362 SH1401 SH1353 SH0098 SH0592 SH1027 SH0181 USG098 USG639 SH0212 SH1375 SH1359 SH1213 SH1337 SH0582 SH1332 SH0802 SH1396 SH0475 SH1394 SH1338 SH0438 SH1367 SH1409 SH1348 SH0829 SH1395 SH1376 USG542 SH0118 SH1389 SH1142 SH1402 SH0379 SH1399 SH1294 SH0830 SH1287 SH1398 SH1335 SH0394 SH1392 SH0483 SH1383 SH1347 SH1325 SH0321 USG623 SH0115 SH0770 SH1412 SH1343 USG334 SH0599 SH1410 SH0847 SH0962 SH1466 SH0168 SH0415 SH0159 SH1413 SH0041 SH1446 SH0418 SH1427 SH0318 SH0921 SH0723 SH1451 SH1022 SH0613 USG114 SH0314 SH1504 SH0476 SH0142 SH1432 SH0729 SH0722 USG221 USG515 SH0837 SH1438 SH0299 SH0609 SH0966 SH1109 SH0169 USG533 USG558…
FDA’s list runs to 5,508 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-USA (nationwide) and the countries of Australia, Austria, Belgium, China, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, 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 Sep 17, 2014.
- FDA classified it on Oct 10, 2014.
- FDA’s Enforcement Report published it on Oct 22, 2014.
- FDA terminated it on Jun 1, 2015.
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: E-Mail.
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 5,508 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.