FDA Device recall Z-0841-2019
daVinci Harmonic ACE Curved Shears
- FDA Device
- Class II
- ongoing
- Published 2019-02-27
On 2019-02-27 the FDA classified a Class II recall of daVinci Harmonic ACE Curved Shears by Intuitive Surgical, citing 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 include….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0841-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-01-16 |
| Published | 2019-02-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Intuitive Surgical |
| Distribution | n/a |
Product
daVinci Harmonic ACE Curved Shears
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.
Identifiers
| code_info | All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0841-2019%22
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