Recall Z-0865-2025— Intuitive Surgical, Inc.

Name: FDA recall Z-0865-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-19

Class II · Ongoing

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2024-12-19. It names one FDA 510(k) clearance: K131861. Product: 8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309. Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-12-19
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K131861 — DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIESIntuitive Surgical, Inc.·cleared 2014-03-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309

Reason for recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Data sourced from openFDA. This site is unofficial and independent of the FDA.