Intuitive Surgical recalls daVinci Harmonic ACE Curved Shears due to potential sterility breaches from damaged packaging during transit. Affected units may have pinholes or small openings in sterile pouches.
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.
“Intuitive Surgical daVinci Harmonic ACE Curved Shears Recall: Sterile Packaging Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69114-intuitive-surgical-davinci-harmonic-ace-curved-shears-recall-sterile-packaging. Based on FDA recall #Z-0841-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0841-2019%22&limit=1).
The FDA announced on Jan. 16, 2019, that Intuitive Surgical, Inc. is recalling daVinci Harmonic ACE Curved Shears due to potential sterility breaches from damaged packaging. The recall affects all lots of the device distributed in the U.S., Australia, and other countries.
How to tell if you have it
Brand: Intuitive Surgical
Product: daVinci Harmonic ACE Curved Shears
Product: da Vinci S/Si Harmonic ACE Inserts
Lots: All Lots
The hazard
Intuitive found that sterile packaging may become damaged during transit, including pinholes or small openings less than a few millimeters. This damage could lead to a potential breach in sterility.
Context
GovInfoNow's records show Intuitive Surgical, Inc. has 53 other recalls on record since June 1, 2017. Recent recalls include the Da Vinci 5 dV5 Tower NIR Handheld Camera recall (April 24, 2026) and the Intuitive Surgical Da Vinci Surgical System Recall (April 22, 2026). Other recent recalls of similar products include Medline 5.5" Sterile Scissors Recall (Nov. 13, 2025), Medline Quick-Strip Bandages Recall (Oct. 27, 2025), and Medline Convenience Kits Recall (June 12, 2026).
How to tell if you have this one
Check for daVinci Harmonic ACE Curved Shears with any lot number. The recall covers all units produced by Intuitive Surgical.
Brand
Intuitive Surgical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Packaging Integrity
Inspect the sterile pouch for pinholes or small openings that could compromise sterility.
How this recall unfolded
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0841-2019 (January 16, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0841-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.