Z-1325-2025Class II

Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730...

Name: Z-1325-2025 Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730...
Creator: Intuitive Surgical, Inc.
Published: 2025-02-26
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2025-02-26 / Open, Classified / root cause: design

FDA source

Intuitive Surgical, Inc. began a recall of Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional... on 2025-02-26. FDA classified it as Class II and gives the reason as "Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1325-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-26
Posted: 2025-03-12
Recalling firm: Intuitive Surgical, Inc.
Product: Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
Root cause tag: design
FDA root cause: Device Design
Action: On February 26, 2025, Intuitive Surgical issued a Urgent: Medical Device Correction to affected consignees via E-Mail. Intuitive asked consignees to take the following actions: 1. Read and understand this notification. 2. Share this notification with all personnel at your site who perform and support da Vinci procedures. 3. Inform affected personnel when the correction has been completed. 4. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 5. Please retain a copy of this letter and the acknowledgement form for your files. 6. Please inform Intuitive of any Adverse Events* or quality problems concerning the use of the subject devices via the standard complaint process 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 8. Complete and submit the report Online Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178. An Intuitive representative will schedule a visit to replace the affected foot tray assembly.
Quantity in commerce: 439 units
Distribution: Worldwide distribution - US Nationwide and the countries of Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the country of South Korea.
Product codes and lots: UDI: 00886874119747/ All da Vinci dV5 consoles and foot trays assemblies manufactured prior to 12/20/2024.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1325-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1325-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-12

Product code NAY

K232610Class IIda Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke EvacuationIntuitive Surgical, Inc. / cleared 2024-03-14

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)