Intuitive Surgical, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0841-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

daVinci Harmonic ACE Curved Shears

Product Classification:

Class II

Date Initiated: January 16, 2019

Date Posted: February 27, 2019

Recall Number: Z-0841-2019

Event ID: 81972

Reason for Recall:

During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. The potential damage includes pinholes and /or small openings (less than a few millimeters) on the pouch leading to a potential breach in sterility.

Status: Ongoing

Product Quantity: 43755 inserts

Code Information:

All Lots

Distribution Pattern:

US and Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Kuwait, Lebanon, Mexico, Monaco, Netherlands, Pakistan, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Korea, Spain, Taiwan, Turkey, United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated