CLASS II ONGOING Device recall · Reported 19 Mar 2025 · FDA Enforcement Report

Da Vinci 5 Assy,DV5 Console,IS5000 Foot Tray Pedals recalled

Intuitive Surgical is recalling Da Vinci 5 Assy,DV5 Console,IS5000 Foot Tray Pedals, distributed nationwide in the US. The recall was initiated on 26 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 00886874119747/ All da Vinci dV5 consoles and foot trays assemblies manufactured prior to 12/20/2024.
Quantity recalled439 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1325-2025
FDA event ID
96345
Recalling firm
Intuitive Surgical, Sunnyvale, CA
Classification
Class II
Status
Ongoing
Recall initiated
26 Feb 2025
FDA classified
12 Mar 2025
Reported
19 Mar 2025
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Device Malfunction
Device type
Medical Software

Timeline

26 Feb 2025Recall initiated by company
12 Mar 2025Classified by FDA+14 days
19 Mar 2025Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide AlaskaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouri

Questions about this recall

Why was it recalled?

Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed

Which lots are affected?

UDI: 00886874119747/ All da Vinci dV5 consoles and foot trays assemblies manufactured prior to 12/20/2024.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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