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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65072

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 13, 2011
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Intuitive Surgical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1426-2013
Recall number
Z-1426-2013
Initiated
October 13, 2011
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
2,423 consignee

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

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).

Code information

NA - marketing and promotional only.

Distribution pattern

USA Nationwide distribution