Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000
Medical device recall Z-0520-2014. Published in FDA’s Enforcement Report on Dec 25, 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 25, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 15, 236 UPDATED 12/19/13 to 11,235 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?
Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.
15, 236 UPDATED 12/19/13 to 11,235, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Part number 400194 on da Vinci IS1200; Lot numbers: 710191 M10110114 710197 M10110204 710261 M10110217 711061 M10110307 711121 M10110321 711191 M10110425 712071 M10110523 712171 M10110603 801041 M10110621 801151 M10110725 801171 M10110728…
Every code shown here, 1,994 characters
Part number 400194 on da Vinci IS1200; Lot numbers: 710191 M10110114 710197 M10110204 710261 M10110217 711061 M10110307 711121 M10110321 711191 M10110425 712071 M10110523 712171 M10110603 801041 M10110621 801151 M10110725 801171 M10110728 801301 M10110810 803171 M10110816 804121 M10110831 805091 M10110909 805271 M10110920 M10090320 S10080609 M10090512 S10080621 M10090709 S10080729 M10090731 S10080812 M10090812 S10080822 M10090824 S10080910 M10090909 S10080918 M10091020 S10081010 M10091110 S10081029 M10091130 S10081106 M10091211 S10081114 M10100114 S10081201 M10100216 S10081215 M10100218 S10090106 M10100428 S10090210 M10100526 S10090303 M10101026 S10090318 M10101103 S10090320 M10101125 S10090410 S10090715 S10110308. Part number 420194 - used on IS2000: lot numbers: 510071 M10090629 S10080802 710191 M10090706 S10080818 710261 M10090724 S10080822 711061 M10090727 S10080902 711121 M10090731 S10080910 711151 M10090810 S10080917 711191 M10090825 S10080926 712051 M10090828 S10080930 712131 M10090909 S10081002 712262 M10090916 S10081009 801021 M10091005 S10081014 801151 M10091008 S10081016 801181 M10091012 S10081029 801241 M10091030 S10081106 801301 M10091105 S10081114 802121 M10091123 S10081119 802201 M10091124 S10081202 802251 M10091130 S10081209 803121 M10091204 S10081218 803211 M10091211 S10081229 803261 M10091217 S10090106 804031 M10100105 S10090112 804111 M10100112 S10090114 804221 M10100114 S10090119 805121 M10100120 S10090121 805271 M10100122 S10090227 805301 M10100208 S10090302 M10090316 M10100216 S10090305 M10090324 S10080609 S10090312 M10090423 S10080618 S10090316 M10090505 S10080625 S10090318 M10090512 S10080708 S10090320 M10090528 S10080714 S10090327 M10090609 S10080723 S10090402 M10090624 S10080729 S10090406 M10100218 M10110112 M10110726 M10100224 M10110117 M10110802 M10100311 M10110131 M10110805 M10100318 M10110202 M10110809 M10100407 M10110208 M10110811 M10100412 M10110210 M10110817 M10100415 M10110218 M10110825 M10100429 M10110301 M10110901 M10100519…
FDA’s list runs to 2,573 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 Puerto Rico) and Internationally to Finland, Belgium, Netherlands, UK, Czech Republic, Sweden, Germany, Austria, Switzerland, Norway, Denmark, South Korea, France, Ireland, and Slovakia.
The states and territories these words name
- Puerto Rico
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 15, 2013.
- FDA classified it on Dec 16, 2013.
- FDA’s Enforcement Report published it on Dec 25, 2013.
- FDA terminated it on Sep 4, 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 2,573 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.