Intuitive Surgical, Inc. recalls Brand Name: Da Vinci 5 Product Name: ASSY

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-1325-2025
• FDA 510(k) clearance · K232610The device's official FDA premarket clearance record
• FDA device classification · NAYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.1500The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Intuitive Surgical, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.