FDA-Device2019-02-27Class II
daVinci Harmonic ACE Curved Shears
Hazard
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.
Sold states
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
Affected count
43755 inserts
Manufactured in
1266 Kifer Rd Bldg 101, Sunnyvale, CA, United States
Products
daVinci Harmonic ACE Curved Shears
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0841-2019More Intuitive Surgical, Inc. recalls
- FDA-Device2026-07-22Intuitive Surgical da Vinci SP Instrument Arm Drape recalled for detachment risk
- FDA-Device2026-07-01Intuitive Surgical Da Vinci surgical system recalled for E-brake failure risk
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