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
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 2025 | Recall initiated by company | |
| 12 Mar 2025 | Classified by FDA | +14 days |
| 19 Mar 2025 | Published 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.
More recalls from Intuitive Surgical
All 256| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | da Vinci SP Instrument Arm Drape, SP recalled by Intuitive Surgical | Intuitive Surgical | Other | Nationwide |
| Device | CLASS II | Da Vinci ASSY, PSS, SP1098 recalled by Intuitive Surgical | Intuitive Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Da Vinci 5 Assy,DV5 Tower,IS5000 recalled by Intuitive Surgical | Intuitive Surgical | Device Malfunction | 49 states |
| Device | CLASS I | Intuitive SureForm 30 Gray Reloads Reference Numbers recalled | Intuitive Surgical | Other | 49 states |
| Device | CLASS II | Da Vinci X and Da Vinci Xi da Vinci X, Xi Surgical System recalled | Intuitive Surgical | Device Malfunction | Nationwide |
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| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |