Recall Z-0406-2024— Intuitive Surgical, Inc.

Name: FDA recall Z-0406-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-06

Class II · Ongoing

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2023-10-06. It names one FDA 510(k) clearance: K152448. Product: Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm. Reason: There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-10-06
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K152448 — da Vinci Single-Site Instrument and AccessoriesIntuitive Surgical, Inc.·cleared 2016-03-09

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 Single-Site Wristed Needle Driver, REF: 478115, 5 mm

Reason for recall

There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.

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