Thyroidectomy Indication for the da Vinci Surgical Systems — Class II medical device recall Z-1426-2013
Terminated recall by Intuitive Surgical, Inc., reported 2013-06-05, distributed nationwide. Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a ch
| Recall number | Z-1426-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2011-10-13 |
| Classified | 2013-05-29 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2013-05-30 |
| Distributed | Nationwide (US) |
| Quantity | 2,423 consignee |
Product
Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical incision because they leave no visible neck scar.
Reason for recall
Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).
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-1426-2013. 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.