Z-2104-2012Class II

Kit,disposable Accessory,3arm,is3000,5 Pack

Name: Z-2104-2012 Kit,disposable Accessory,3arm,is3000,5 Pack
Creator: Intuitive Surgical, Inc.
Published: 2012-07-13
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2012-07-13 / Terminated / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to... on 2012-07-13. FDA classified it as Class II and gives the reason as "Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2104-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-13
Posted: 2012-07-27
Terminated: 2013-06-12
Recalling firm: Intuitive Surgical, Inc.
Product: KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; 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.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Intuitive Surgical sent an Urgent Medical Device Correction letters dated July 16, 2012 via Fed Ex to all affected customers in the US. The customers outside of the US were notified starting July 17, 2012. The letter identified the affected products, problem and actions to be taken. Customers were instructed to Identify affected lots, order replacement products and return both full and partial boxes of the affected products for credit as soon as unaffected products are available. All staff should be made aware of the issue. Customers were instructed to complete and return the acknowledgement form immediately. Questions and concerns should be directed to Intuitive Customer Service at 1-800-876-1310. EXPANSION: Intuitive discovered an additional lot (Lot DA121075) of Instrument Arm Drape IS2000, 20 pack that should have been included in the recall and expanded the recall on September 4, 2012. Letters to customers were sent by Fed Ex on September 5, 2012.
Quantity in commerce: 92390 total instrument Drapes
Distribution: Worldwide Distribution - US Nationwide and the countries of: Australia, Spain, India, Italy and Saudi Arabia.
Product codes and lots: Part number: 420290-03 Lot numbers: D120735,,D120745,D120815, D120815A, D120885, D120895, D120905 D120945, D120955, D120955A, D120965, D121025, D121035, D121045, D121075, D121075A, D121095, D121155, D121165, D121165A, D121215.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2104-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2101-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-07-27
Z-2102-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-07-27
Z-2103-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-07-27
Z-2104-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-07-27
Z-2105-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-07-27
Z-2106-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-07-27

Product code NAY

K050369Class IIIntuitive Surgical Da Vinci Surgical System, Model Is2000Intuitive Surgical, Inc. / cleared 2005-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)