Intuitive Surgical, Inc.: KIT,DISPOSABLE ACCESSORY,4ARM,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.

Recall number

Z-2105-2012

Recalling firm

Intuitive Surgical, Inc.

Product

KIT,DISPOSABLE ACCESSORY,4ARM,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.

Status

Terminated

Initiated

2012-07-13

Posted

2012-07-27

Terminated

2013-06-12

Reason

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

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

92390 total instrument Drapes

Distribution

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

Lot, serial or model codes

Part number: 420291-03 Lot numbers: D120795 ,D120795A , D120805, D120815, D120875, D120885, D120885A, D120935, D120935A,D120945 D121015 D121025 D121025A D121105 D121105A D121355A

510(k) numbers

["K050369"]

PMA numbers

not on file

Product code

NAY

Firm FEI

3001675293

Firm city

Sunnyvale

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy