da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si… — Class II medical device recall Z-1463-2013
Terminated recall by Intuitive Surgical, Inc., reported 2013-06-12, distributed nationwide. Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the
| Recall number | Z-1463-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2013-05-06 |
| Classified | 2013-06-05 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2014-04-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, DE, DK, FI, FR, GB, IE, KR, NL, NO, SE |
| Quantity | 2,101 consignees |
| Model numbers | 420011 |
Product
da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments,
Reason for recall
Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).
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-1463-2013. 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.