Da Vinci 5 (Intuitive Surgical) – Foot Tray Pedal Failure (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Intuitive Surgical, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI: 00886874119747/ All da Vinci dV5 consoles and foot trays assemblies manufactured prior to 12/20/2024.
Intuitive Surgical, Inc. is recalling Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number due to Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
Recommended Action
Per FDA guidance
On February 26, 2025, Intuitive Surgical issued a Urgent: Medical Device Correction to affected consignees via E-Mail. Intuitive asked consignees to take the following actions: 1. Read and understand this notification. 2. Share this notification with all personnel at your site who perform and support da Vinci procedures. 3. Inform affected personnel when the correction has been completed. 4. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 5. Please retain a copy of this letter and the acknowledgement form for your files. 6. Please inform Intuitive of any Adverse Events* or quality problems concerning the use of the subject devices via the standard complaint process 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 8. Complete and submit the report Online Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178. An Intuitive representative will schedule a visit to replace the affected foot tray assembly.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026