FDA Device recall Z-1426-2013
Thyroidectomy Indication for the da Vinci Surgical Systems
- FDA Device
- Class II
- terminated
- Published 2013-06-05
On 2013-06-05 the FDA classified a Class II recall of Thyroidectomy Indication for the da Vinci Surgical Systems by Intuitive Surgical, citing promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1426-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-10-13 |
| Published | 2013-06-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
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
Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).
Identifiers
| code_info | NA - marketing and promotional only. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1426-2013%22
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