Recall Z-2521-2026— Intuitive Surgical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2026-04-22. It names 2 FDA 510(k) clearances: K182371, K173906. Product: Da Vinci ASSY, PSS, SP1098, Part Number: 380601. Reason: Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding..
- Recalling firm
- Intuitive Surgical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-04-22
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K182371 — da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
- K173906 — da Vinci SP Surgical System, EndoWrist SP 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
Da Vinci ASSY, PSS, SP1098, Part Number: 380601
Reason for recall
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.
Data sourced from openFDA. This site is unofficial and independent of the FDA.