daVinci Harmonic ACE Curved Shears — Class II medical device recall Z-0841-2019
Ongoing recall by Intuitive Surgical, Inc., reported 2019-02-27. During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE In
| Recall number | Z-0841-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2019-01-16 |
| Classified | 2019-02-15 |
| Reported by FDA | 2019-02-27 |
| Countries outside the US | AT, AU, BE, BR, CA, CL, CN, CO, DE, DK, ES, FI, FR, GB, IL, IN, IT, JP, KR, KW, LB, MX, NL, PK, QA, RO, SA, SG, TR, TW |
| Quantity | 43,755 inserts |
| Reason classes | sterility |
Product
daVinci Harmonic ACE Curved Shears
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0841-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.