RegWardenFDA facility compliance records
Recall

Class II — Intuitive Surgical, Inc.

Recalling firmIntuitive Surgical, Inc.
Registered facilityView this company's 41 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonPatient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging.
ProductPatient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086
Quantity2606
DistributionWorldwide Distribution.
Initiated2012-04-27
Classified2014-07-04
Terminated2014-07-07
Recall numberZ-1994-2014
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Intuitive Surgical, Inc. (Z-1994-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68593/

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