FDA Device recall Z-1428-2026
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery
- FDA Device
- Class II
- ongoing
- Published 2026-02-25
On 2026-02-25 the FDA classified a Class II recall of Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery by Intuitive Surgical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1428-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-17 |
| Published | 2026-02-25 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Intuitive Surgical |
| Distribution | LA, MA, NY, PA, TX, VA |
Product
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Reason
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.
Identifiers
| code_info | UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by Intuitive Surgical
- da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
FDA Device · Class II · 2026-07-22 · Intuitive Surgical - Da Vinci ASSY, PSS, SP1098, Part Number: 380601
FDA Device · Class II · 2026-07-01 · Intuitive Surgical - Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface:…
FDA Device · Class II · 2026-06-10 · Intuitive Surgical - Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000
FDA Device · Class II · 2026-05-13 · Intuitive Surgical - Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
FDA Device · Class I · 2026-05-13 · Intuitive Surgical
All Intuitive Surgical recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1428-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.