FDA Medical devices recall ·
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model recall
- Recall number
- Z-1428-2026
- Date
- (initiated November 17, 2025)
- Company / brand
- Intuitive Surgical, Inc.
1266 Kifer Rd, Sunnyvale, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 12
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1
Distribution
US distribution: LA, MA, NY, PA, TX, and VA.
States: Louisiana Massachusetts New York Pennsylvania Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1428-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.