Intuitive Surgical, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2720-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Ion Endoluminal System, REF: 380748-65

Product Classification:

Class II

Date Initiated: July 12, 2024

Date Posted: September 4, 2024

Recall Number: Z-2720-2024

Event ID: 95046

Reason for Recall:

There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.

Status: Ongoing

Product Quantity: 3 units

Code Information:

UDI: 00886874116234/ System Serial Number/System Cart Serial Number: EN1230/10591271; EN1241/10591273; EN1231/10583014

Distribution Pattern:

US Nationwide distribution in the states of AZ and CA.

Voluntary or Mandated:

Voluntary: Firm initiated