CLASS II ONGOING Device recall · Reported 25 Feb 2026 · FDA Enforcement Report
Da Vinci 5 Assy, DV5 Console, IS5000 recalled by Intuitive Surgical
Intuitive Surgical is recalling Da Vinci 5 Assy, DV5 Console, IS5000, distributed in Louisiana, Massachusetts, New York, Pennsylvania, Texas, Virginia. The recall was initiated on 17 Nov 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-1428-2026
- FDA event ID
- 98200
- Recalling firm
- Intuitive Surgical, Sunnyvale, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Nov 2025
- FDA classified
- 18 Feb 2026
- Reported
- 25 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 17 Nov 2025 | Recall initiated by company | |
| 18 Feb 2026 | Classified by FDA | +93 days |
| 25 Feb 2026 | 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
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
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
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Where it was distributed
US distribution: LA, MA, NY, PA, TX, and VA.
Questions about this recall
Why was it recalled?
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
Which lots are affected?
UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1
Where was it sold?
US distribution: LA, MA, NY, PA, TX, and VA.
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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