Intuitive Surgical, Inc. recalls daVinci Harmonic ACE Curved Shears

Recall date

January 16, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0841-2019

FDA classification

Class II

Brand / firm

Intuitive Surgical, Inc.

Sold / distributed

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…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

daVinci Harmonic ACE Curved Shears