Recall Z-0880-2025— Intuitive Surgical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2024-12-19. It names 2 FDA 510(k) clearances: K214095, K131861. Product: 8MM,MEGA SUTURECUT ND,IS4000 REF 471309. 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
2 on FDA's record- K214095 — da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
- K131861 — DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
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 471309
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.