Z-2329-2020Class II

STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 -

Name: Z-2329-2020 STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 -
Creator: Intuitive Surgical, Inc.
Published: 2019-12-19
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2019-12-19 / Terminated / root cause: design

FDA source

Intuitive Surgical, Inc. began a recall of STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is designed to enable complex surgery using a minimally... on 2019-12-19. FDA classified it as Class II and gives the reason as "Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2329-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-19
Posted: 2020-06-09
Terminated: 2023-08-31
Recalling firm: Intuitive Surgical, Inc.
Product: STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
Product code: KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Reason for recall: Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may cause these holes.
Root cause tag: design
FDA root cause: Device Design
Action: The firm sent a Field Safety Notice, titled Urgent Medical Device Correction Letter - ISIFA2019-10-C to customers via FedEx starting on December 19, 2019. The letter informed customers that the firm had received complaints regarding small but detectable holes in the sterilization wrap used with da Vinci Xi 8 mm Endoscope Sterilization Trays (PN 400498-02) and Handheld Camera Sterilization Trays (PN 400499-03). Customers were informed that certain features on the trays, in combination with loading and unloading of wrapped trays into sterilizers, and stacking and unstacking of wrapped trays during handling and storage could lead to these holes and a potential breach of sterility and infection in patients. Instructions were provided on steps to be taken to mitigate the potential for development of small holes, to be used in conjunction with industry practice. This included: 1. to avoid dragging a wrapped tray when loading and unloading the sterilizer; 2. to lift trays instead of sliding or dragging on and off workbenches, shelves, and other horizontal surfaces, and 3. sites using sterilizers with interior brackets were advised that they should avoid dragging trays across interior brackets. Customers were also advised to continue to inspect wrapped trays prior to use per hospital policy, and to continue to follow instructions located in the da Vinci Xi Endoscope Reprocessing Instructions and da Vinci Xi Handheld Camera Reprocessing Instructions Addendum regarding stainless steel trays. Customers were requested to inform necessary hospital personnel about this issue, complete the attached Acknowledgement Form acknowledging they had received and read the notice, ensured all personnel were fully informed of the contents, would contact Intuitive with any questions, and would retain a copy of this letter for their files. The Acknowledgement Forms were to be faxed or emailed to Intuitive Surgical as follows: ATTN: REGULATORY COMPLIANCE FIELD ACTIONS Subject line for
Quantity in commerce: 16 Trays
Distribution: Worldwide distribution - US Nationwide distribution including in the states of Arkansas, Arizona, Alabama, Alaska, California, Connecticut, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Idaho, Kentucky, Kansas, Louisiana, Missouri, Michigan, Maryland, Mississippi, Minnesota, Montana, Maine, Massachusetts, Nevada, New York, North Dakota, Nebraska, North Carolina, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin, Washington and West Virginia. Multiple countries including Canada.
Product codes and lots: Model No. 400499-03; All Batch Numbers; UDI: 00886874115855

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2329-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2328-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2329-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09

Product code KCT

K191043Class IIda Vinci Handheld CameraIntuitive Surgical, Inc. / cleared 2019-06-06

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)