Recall Z-1096-2026— Intuitive Surgical, Inc.

Name: FDA recall Z-1096-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-15

Class II · Ongoing

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2025-12-15. It names one FDA 510(k) clearance: K202571. Product: da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box). Reason: Access Port System tray may develop cracks potentially resulting in a sterility breach..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-12-15
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K202571 — da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.·cleared 2020-11-12

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 SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)

Reason for recall

Access Port System tray may develop cracks potentially resulting in a sterility breach.

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