Z-1392-2015Class II

da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment...

Name: Z-1392-2015 da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment...
Creator: Intuitive Surgical, Inc.
Published: 2015-03-16
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2015-03-16 / Terminated / root cause: packaging

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical... on 2015-03-16. FDA classified it as Class II and gives the reason as "Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1392-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-16
Posted: 2015-04-06
Terminated: 2015-12-03
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 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.
Product code: KKX Drape, Surgical, Antimicrobial
Reason for recall: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Firm issued field safety notice to all customers on March 16, 2015. Field safety notice includes acknowledgement form to be returned to recalling firm. A second letter was sent on May 12, 2015 to inform users that the date that the drape product unaffected by the issue will not be availalble untisl October/November 2015, not May 2015 as stated in the original communication.
Quantity in commerce: 442,475 total for all drape models
Distribution: Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.
Product codes and lots: Product number 420290-03; da Vinci Si Disposable Accessory Kit, 3 ARM, 5 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: D142175, D142175A, D142185, D142185A, D142235, D142235A, D142245, D142245A, D142255, D142305, D142305A, D142315, D142315A, D142345, D142375, D142375A, D142385, D142385A, D142395, D142455, D142465, D142465A, D142475, D142475A, D142485, D142515, D142515A, D142525, D142525A, D142535, D142535A, D142605, D142605A, D142615, D142615A, D142625, D142635, D142655, D142655A, D142665, D142665A, D142725, D142725A, D142735, D142735A, D142745, D142755, D142755A, D142795, D142795A, D142825, D142825A, D142835, D142885, D142885A, D142885A, D142895, D142905, D142945, D142955, D142955A, D142965, D142965A, D143005, D143015, D143015A, D143025, D143025A, D143035, D143045, D143045A, D143095, D143095A, D143105, D143105A, D143155, D143155A, D143165, D143165A, D143175, D143175A, D143185, D143185A, D143215, D143215A, D143225, D143225A, D143235, D143235A, D143295, D143295A, D143305, D143305A, D143315, D143325, D143325A, D143365, D143375, D143375A, D143385, D143395, D143395A, D143435, D143445, D143445A, D143455, D143455A, D143465, D143465A, D150075, D150085, D150125, D150125A, D150135, D150165, D150195, D150195A, D150205, D150205A, D150275, D150275A, D150285, D150305, D150345, D150345A, D150355, D150355A, D150415, D150415A, D150425, D150425A, D150435, D150475, D150475A, D150485, D150485A, D150495, D150545, D150545A, D150555, D150555A, D150635, D150635A, D150645, D150645A, D150685, D150685A, D150695, D150695A, DA142235, DA142305, DA142515, DA142615, DA142795, DA142885, DA142885, DA143025, DA150125, DA150275, DA150475, DA150545, DA150645, DA150685

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1392-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1380-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-06
Z-1381-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-06
Z-1382-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-06
Z-1383-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-06
Z-1384-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-06
Z-1385-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-06
Z-1386-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-06
Z-1387-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-06
Z-1388-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-06
Z-1389-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-06
Z-1390-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-06
Z-1391-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-06
Z-1392-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-06
Z-1393-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-06

Product code KKX

K050322Class IIMicrotek Equipment DrapesMicrotek Medical, Inc. / cleared 2005-05-17

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)