Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000
Medical device recall Z-0521-2014. 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
- 94, 981 UPDATED 12/19/13 to 56, 469 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?
Large 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.
94, 981 UPDATED 12/19/13 to 56, 469, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Part number 400006 on da Vinci IS1200; Lot numbers: 710182 801282 805131 M10080716 M10080910 M10090216 M10091104 M10100728 S10080613 710192 802042 805221 M10080718 M10081014 M10090225 M10091110 M10100729 S10080618 710262 802052 805271…
Every code shown here, 1,995 characters
Part number 400006 on da Vinci IS1200; Lot numbers: 710182 801282 805131 M10080716 M10080910 M10090216 M10091104 M10100728 S10080613 710192 802042 805221 M10080718 M10081014 M10090225 M10091110 M10100729 S10080618 710262 802052 805271 M10080721 M10081024 M10090325 M10091113 M10100804 S10080624 710301 802061 910072 M10080722 M10081027 M10090325 M10091120 M10100810 S10080626 710302 802072 1610072 M10080723 M10081028 M10090401 M10091130 M10100813 S10080708 711052 802082 M10080603 M10080724 M10081029 M10090407 M10091209 M10100820 S10080709 711062 802122 M10080603 M10080725 M10081031 M10090415 M10091211 M10100902 S10080711 711072 802131 M10080603 M10080728 M10081104 M10090417 M10091214 M10100924 S10080712 711082 802152 M10080605 M10080729 M10081110 M10090427 M10091216 M10100927 S10080715 711092 802202 M10080606 M10080730 M10081111 M10090505 M10100113 M10100929 S10080718 711122 802212 M10080609 M10080731 M10081112 M10090514 M10100118 M10101026 711142 802252 M10080610 M10080801 M10081117 M10090519 M10100123 M10101103 711152 802262 M10080612 M10080804 M10081119 M10090521 M10100128 M10101118 711262 802272 M10080616 M10080805 M10081120 M10090526 M10100129 M10101123 711282 803042 M10080617 M10080806 M10081124 M10090604 M10100209 M10101124 711302 803101 M10080618 M10080807 M10081125 M10090605 M10100212 M10101209 712042 803112 M10080618 M10080808 M10081127 M10090616 M10100222 M10110113 712062 803132 M10080618 M10080811 M10081128 M10090704 M10100225 M10110131 712102 803172 M10080619 M10080812 M10081201 M10090713 M10100302 M10110208 712112 803192 M10080620 M10080813 M10081204 M10090717 M10100308 M10110210 712142 803212 M10080623 M10080814 M10081205 M10090728 M10100312 M10110217 712182 803241 M10080624 M10080815 M10081209 M10090810 M10100323 M10110224 712192 803261 M10080625 M10080818 M10081210 M10090811 M10100326 M10110304 712212 803271 M10080626 M10080819 M10081211 M10090817 M10100408 M10110310 801021 804081 M10080627 M10080820 M10081218 M10090826 M10100430 M10110317 801072…
FDA’s list runs to 8,310 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 8,310 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.