Intuitive Surgical, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1518-2024)

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:

Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098

Product Classification:

Class II

Date Initiated: March 13, 2024

Date Posted: April 17, 2024

Recall Number: Z-1518-2024

Event ID: 94252

Reason for Recall:

Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.

Status: Ongoing

Product Quantity: 53

Code Information:

Part/UDI-DI: 380601/00886874114605. SP1098 Serial Numbers: SP0202, SP0253, SP0254, SP0219, SP0228, SP0231, SP0238, SP0273, SP0208, SP0226, SP0240, SP0247, SP0249, SP0256, SP0257, SP0268, SP0270, SP0272, SP0221, SP0223, SP0225, SP0229, SP0230, SP0232, SP0233, SP0235, SP0236, SP0237, SP0239, SP0241, SP0242, SP0243, SP0244, SP0245, SP0248, SP0250, SP0251, SP0252, SP0255, SP0258, SP0259, SP0260, SP0261, SP0262, SP0263, SP0264, SP0265, SP0266, SP0269, SP0274, SP0278, SP0280, SP0282

Distribution Pattern:

US: VA, CA, NH, FL, NY, CO, AL, KY, MD, NC, NJ, OH, SC, SD, TN, WA, WI, WV, MS, TX, KS. OUS: China, France, Japan, South Korea

Voluntary or Mandated:

Voluntary: Firm initiated