da Vinci Xi Surgical System
Medical device recall Z-1293-2023. Published in FDA’s Enforcement Report on Apr 5, 2023.
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 Apr 5, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Puerto Rico the one state its words name
- 1,225 total USMs 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?
Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
1,225 total USMs, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200 Part Number: 380647 UDI-DI Code: 00886874114216 Serial Numbers: RSK8062 RSK8104 RSK8128 RSK8130 RSK8134 RSK8135 RSK8136 RSK8137 RSK8138 RSK8139 RSK8143…
Every code shown here, 1,995 characters
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200 Part Number: 380647 UDI-DI Code: 00886874114216 Serial Numbers: RSK8062 RSK8104 RSK8128 RSK8130 RSK8134 RSK8135 RSK8136 RSK8137 RSK8138 RSK8139 RSK8143 RSK8144 RSK8146 RSK8147 RSK8148 RSK8149 RSK8152 RSK8153 RSK8154 RSK8158 RSK8159 RSK8160 RSK8162 RSK8163 RSK8164 RSK8166 RSK8167 RSK8168 RSK8170 RSK8172 SK0050 SK0055 SK0090 SK0091 SK0101 SK0112 SK0128 SK0137 SK0141 SK0151 SK0153 SK0160 SK0169 SK0211 SK0213 SK0221 SK0280 SK0285 SK0329 SK0382 SK0383 SK0393 SK0395 SK0420 SK0429 SK0433 SK0499 SK0511 SK0518 SK0540 SK0548 SK0563 SK0607 SK0612 SK0618 SK0636 SK0644 SK0661 SK0662 SK0710 SK0739 SK0749 SK0751 SK0765 SK0783 SK0805 SK0811 SK0827 SK0852 SK0866 SK0875 SK0893 SK0912 SK0937 SK0957 SK0968 SK0976 SK0980 SK1008 SK1009 SK1040 SK1063 SK1092 SK1101 SK1102 SK1118 SK1136 SK1143 SK1182 SK1187 SK1211 SK1249 SK1251 SK1261 SK1273 SK1290 SK1322 SK1341 SK1382 SK1385 SK1405 SK1423 SK1428 SK1436 SK1450 SK1470 SK1482 SK1535 SK1565 SK1571 SK1574 SK1581 SK1597 SK1607 SK1634 SK1635 SK1639 SK1651 SK1686 SK1758 SK1784 SK1808 SK1845 SK1863 SK1880 SK1926 SK1936 SK1967 SK1990 SK1993 SK2101 SK2119 SK2132 SK2144 SK2194 SK2274 SK2287 SK2333 SK2403 SK2404 SK2413 SK2454 SK2486 SK2504 SK2508 SK2512 SK2520 SK2538 SK2539 SK2540 SK2541 SK2573 SK2575 SK2654 SK2658 SK2667 SK2748 SK2764 SK2765 SK2798 SK2809 SK2845 SK2923 SK2988 SK3000 SK3182 SK3277 SK3291 SK3294 SK3393 SK3413 SK3504 SK3518 SK3545 SK3554 SK3602 SK3645 SK3727 SK3763 SK3799 SK3893 SK3922 SK3941 SK3956 SK4102 SK4178 SK4181 SK4207 SK4246 SK4250 SK4321 SK4328 SK4400 SK4416 SK4501 SK4562 SK4576 SK4674 SK4691 SK4692 SK4769 SK4802 SK4819 SK4825 SK4862 SK4906 SK4966 SK4987 SK5011 SK5033 SK5063 SK5098 SK5108 SK5129 SK5149 SK5202 SK5316 SK5322 SK5351 SK5447 SK5530 SK5547 SK5553 SK5554 SK5555 SK5561 SK5564 SK5567 SK5568 SK5570 SK5575 SK5576 SK5579 SK5580 SK5582 SK5583 SK5585 SK5586 SK5587 SK5588 SK5590 SK5591 SK5592 SK5593 SK5594 SK5596 SK5598 SK5599 SK5600 SK5601…
FDA’s list runs to 4,640 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.
U.S.: Cayman Islands, Dominican Republic, Puerto Rico, United States O.U.S.: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Luxembourg, Martinique, Monaco, Netherlands, Norway, Reunion, Sweden, Switzerland, United Kingdom, India, Japan, South Korea, Taiwan, Brazil, Argentina, Australia, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, Indonesia, Israel, Italy, Kuwait, Lebanon, Malaysia, Malta, Mexico, New Zealand, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Thailand, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam
The states and territories these words name
- Puerto Rico
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Feb 10, 2023.
- FDA classified it on Mar 28, 2023.
- FDA’s Enforcement Report published it on Apr 5, 2023.
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 4,640 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
-
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.