FDA Medical Device Recalls (openFDA)
Intuitive Surgical, Inc.: daVinci Harmonic ACE Curved Shears
- Recall number
- Z-0841-2019
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- daVinci Harmonic ACE Curved Shears
- Status
- Open, Classified
- Initiated
- 2019-01-16
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- A Stop Use Notification was sent to affected customers on December 19, 2018. This notification requested customers to return the device. The formal customer recall letter was sent on January 16, 2019.
- Quantity
- 43755 inserts
- 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, serial or model codes
- All Lots
- 510(k) numbers
- ["K093217","K112584"]
- PMA numbers
- not on file
- Product code
- NAY
- Firm FEI
- 3001675293
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28