Z-0841-2019Class II

daVinci Harmonic ACE Curved Shears

Name: Z-0841-2019 daVinci Harmonic ACE Curved Shears
Creator: Intuitive Surgical, Inc.
Published: 2019-01-16
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2019-01-16 / Open, Classified / root cause: packaging

FDA source

Intuitive Surgical, Inc. began a recall of daVinci Harmonic ACE Curved Shears on 2019-01-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0841-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-01-16
Posted: 2019-02-15
Recalling firm: Intuitive Surgical, Inc.
Product: daVinci Harmonic ACE Curved Shears
Product code: NAY System, Surgical, Computer Controlled Instrument
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.
Root cause tag: packaging
FDA 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 in commerce: 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
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0841-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0841-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-02-27	2019-02-15

Product code NAY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)