Data Foundry

Medical device recalls 2025

Brand Name: Da Vinci 5 Product Name: ASSY — Class II medical device recall Z-1325-2025

Ongoing recall by Intuitive Surgical, Inc., reported 2025-03-19, distributed nationwide. Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pr

Recall numberZ-1325-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmIntuitive Surgical, Inc., Sunnyvale, CA, United States
Recall initiated2025-02-26
Classified2025-03-12
Reported by FDA2025-03-19
DistributedNationwide (US)
Countries outside the USKR, MX
Quantity439 units
UPC / GTIN / UDI-DI00886874119747
Model numbers380730

Product

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

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1325-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.