RecallRadar

FDA Device recall Z-2020-2014

Intuitive Surgical Inc

On 2014-07-16 the FDA classified a Class II recall of Intuitive Surgical Inc by Intuitive Surgical, citing 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 re….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2020-2014
ClassificationClass II
Statusterminated
Initiated2014-06-13
Published2014-07-16
Last updated2026-09-13 11:53 UTC
CompanyIntuitive Surgical
Distributionn/a

Product

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

Reason

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..

Identifiers

code_info
All product manufactured after May 16, 2014 with lot numbers starting with M10120516. Part number 420230-06; Batch num…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2020-2014%22

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