Reported Apr 15, 2015 · Terminated

da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are…

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?

  • da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
Lot codes and dates
    • Product number 420015-03
    • da Vinci S / Si Instrument Arm Drape
    • 20 Pack
  • Lot Numbers for Cloudy/Waxy issueALL
  • lot numbers Lot Numbers for Tear issue

    418 of 418 codes

    • D142175
    • D142535
    • D142895
    • D143255
    • D150135A
    • D150555
    • DA142695A
    • DA143465A
    • D142175A
    • D142535A
    • D142895A
    • D143255A
    • D150145
    • D150555A
    • DA142725
    • DA143515
    • D142185
    • D142545
    • D142905
    • D143285
    • D150145A
    • D150565
    • DA142745
    • DA150075
    • D142185A
    • D142545A
    • D142905A
    • D143285A
    • D150155
    • D150565A
    • DA142745A
    • DA150085
    • D142195
    • D142555
    • D142915
    • D143295
    • D150155A
    • D150575
    • DA142755
    • DA150085A
    • D142195A
    • D142555A
    • D142915A
    • D143295A
    • D150165
    • D150575A
    • DA142755A
    • DA150125
    • D142205
    • D142585
    • D142935
    • D143305
    • D150165A
    • D150625
    • DA142765
    • DA150125A
    • D142205A
    • D142585A
    • D142935A
    • D143305A
Amount recalled
442,475 total for all drape models

This recall covers 14 products

The agency filed one notice per product. You are reading one of them; the other 13 are below.

1 more are in the archive.

Where it was sold

Why it was recalled

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 3, 2015 · Data as of Sep 19, 4:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.