Reported Apr 15, 2015 · Terminated

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

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, Camera 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 420022-02
    • da Vinci S Camera Arm Drape
    • 20 Pack
  • Lot Numbers for Cloudy/Waxy issueALL
  • lot numbers Lot Numbers for Tear issue

    75 of 75 codes

    • D142205
    • D142205A
    • D142275
    • D142275A
    • D142315
    • D142325
    • D142335
    • D142345
    • D142345A
    • D142375
    • D142375A
    • D142385
    • D142485
    • D142625
    • D142625A
    • D142655
    • D142685
    • D142695
    • D142695A
    • D142765
    • D142765A
    • D142835
    • D142835A
    • D142905
    • D142905A
    • D142965
    • D142975
    • D143015
    • D143035
    • D143035A
    • D143105
    • D143115
    • D143175
    • D143175A
    • D143185
    • D143245
    • D143255
    • D143255A
    • D143315
    • D143315A
    • D143385
    • D143385A
    • D143445
    • D143445A
    • D143515
    • D143515A
    • D150085
    • D150085A
    • D150095
    • D150155
    • D150155A
    • D150215
    • D150215A
    • D150295
    • D150295A
    • D150355
    • D150365
    • D150365A
    • D150425
    • D150435
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, 5:31 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.