medical Class II Updated 2019-02-27

Intuitive Surgical, Inc. recalls daVinci Harmonic ACE Curved Shears

Recalled Product

daVinci Harmonic ACE Curved Shears

Hazard / Issue

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.

Issued by

FDA

Distribution: 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

Lot/Code Info: All Lots

View official government recall

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