CLASS II Device recall · Reported 8 Aug 2012 · FDA Enforcement Report

Accessory Base Starter Kit,is3000 recalled by Intuitive Surgical

Intuitive Surgical is recalling Accessory Base Starter Kit,is3000, distributed nationwide in the US. The recall was initiated on 13 Jul 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart number: 380595-02 Lot numbers: 298601, 298602, 298608, 298613, 298625, 298627, 298629.

Quantity recalled92390 total instrument Drapes

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2106-2012
FDA event ID: 62553
Recalling firm: Intuitive Surgical, Sunnyvale, CA
Classification: Class II
Status: Terminated
Recall initiated: 13 Jul 2012
FDA classified: 27 Jul 2012
Reported: 8 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

13 Jul 2012	Recall initiated by company
27 Jul 2012	Classified by FDA	+14 days
8 Aug 2012	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.

Where it was distributed

Worldwide Distribution - US Nationwide and the countries of: Australia, Spain, India, Italy and Saudi Arabia.

Nationwide

Questions about this recall

Is Accessory Base Starter Kit,is3000 recalled?

Yes. Intuitive Surgical recalled Accessory Base Starter Kit,is3000 on 13 Jul 2012. The recall is Class II and its status is Terminated. Recall number Z-2106-2012.

Why was it recalled?

Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.

Which lots are affected?

Part number: 380595-02 Lot numbers: 298601, 298602, 298608, 298613, 298625, 298627, 298629.

Where was it sold?

Worldwide Distribution - US Nationwide and the countries of: Australia, Spain, India, Italy and Saudi Arabia.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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