Intuitive Surgical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2131-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.

Product Classification:

Class II

Date Initiated: August 19, 2019

Date Posted: June 3, 2020

Recall Number: Z-2131-2020

Event ID: 85324

Reason for Recall:

Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging; additionally if a small piece of inert epoxy were to be retained, scar tissue could form.

Status: Ongoing

Product Quantity: 305 units

Code Information:

Model Number: 430060-33; UDI Number: 00886874114384; All serial numbers.

Distribution Pattern:

Distribution US nationwide and South Korea.

Voluntary or Mandated:

Voluntary: Firm initiated