Intuitive Surgical Inc
Medical device recall Z-2020-2014. Published in FDA’s Enforcement Report on Jul 16, 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 Jul 16, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 5290 for part 420230-04; 1964 for part 420240-06 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?
Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the instrument jamming during insertion when used with the 8 mm cannula or with certain reducer accessories..
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., ‘Sunnyvale, CA 94086
5290 for part 420230-04; 1964 for part 420240-06, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All product manufactured after May 16, 2014 with lot numbers starting with M10120516. Part number 420230-06; Batch numbers: M10131018 M10131022 M10131025 M10131105 M10131108 M10131112 M10131115 M10131122 M10131123 M10131126 M10131211…
Every code shown here, 1,353 characters
All product manufactured after May 16, 2014 with lot numbers starting with M10120516. Part number 420230-06; Batch numbers: M10131018 M10131022 M10131025 M10131105 M10131108 M10131112 M10131115 M10131122 M10131123 M10131126 M10131211 M10131218 M10140109 M10140113 M10140204 M10140224 M10140313 M10140509 M11140224 N10140117 N10140121 N10140227 N10140319 N10140325 N10140403 N10140429 N10140515. Part number 420230-04, Batch numbers: M10120516 M10120523 M10120529 M10120530 M10120607 M10120615 M10120627 M10120628 M10120629 M10120702 M10120704 M10120706 M10120712 M10120716 M10120718 M10120724 M10120727 M10120731 M10120803 M10120807 M10120813 M10120817 M10120827 M10120830 M10120911 M10120918 M10120925 M10121001 M10121009 M10121015 M10121025 M10121030 M10121105 M10121113 M10121116 M10121126 M10121128 M10121203 M10121205 M10121207 M10121213 M10130103 M10130109 M10130115 M10130122 M10130129 M10130131 M10130207 M10130212 M10130215 M10130225 M10130228 M10130305 M10130307 M10130314 M10130315 M10130321 M10130401 M10130403 M10130416 M10130418 M10130423 M10130429 M10130501 M10130508 M10130517 M10130521 M10130528 M10130529 M10130530 M10130606 M10130608 M10130627 M10130702 M10130724 M10130725 M10130806 M10130809 M10130819 M10130827 M10130904 M10130906 M10130918 M10130925 M10131002 M10131004 M10131010 N10130919 N11130925 S10121108 S10130109 S10130722.
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.
These words name no state.
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?
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 Jun 13, 2014.
- FDA classified it on Jul 8, 2014.
- FDA’s Enforcement Report published it on Jul 16, 2014.
- FDA terminated it on Dec 1, 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.”
- 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.