Reported Jul 16, 2014 · Terminated
Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 100 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- 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
- Lot codes and dates
- All product manufactured after May 16, 2014 with lot numbers starting with M10120516. Part number 420230-06
- Batch numbersPart number 420230-04
M10131018M10131022M10131025M10131105M10131108M10131112M10131115M10131122M10131123M10131126M10131211M10131218M10140109M10140113M10140204M10140224M10140313M10140509M11140224N10140117N10140121N10140227N10140319N10140325N10140403N10140429N10140515.
- Batch numbers
92 of 92 codes
M10120516M10120523M10120529M10120530M10120607M10120615M10120627M10120628M10120629M10120702M10120704M10120706M10120712M10120716M10120718M10120724M10120727M10120731M10120803M10120807M10120813M10120817M10120827M10120830M10120911M10120918M10120925M10121001M10121009M10121015M10121025M10121030M10121105M10121113M10121116M10121126M10121128M10121203M10121205M10121207M10121213M10130103M10130109M10130115M10130122M10130129M10130131M10130207M10130212M10130215M10130225M10130228M10130305M10130307M10130314M10130315M10130321M10130401M10130403M10130416
- Amount recalled
- 5290 for part 420230-04; 1964 for part 420240-06
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
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..
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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