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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65083

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 19, 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

3 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 3

Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.

Z-1427-2013
Recall number
Z-1427-2013
Initiated
September 19, 2011
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
NA

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Clarification of existing labeling information and operating procedures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Clarification of existing labeling information and operating procedures.

Code information

Model number 420002-07

Distribution pattern

Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.

device · product 2 of 3

Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.

Z-1428-2013
Recall number
Z-1428-2013
Initiated
September 19, 2011
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
NA

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Clarification of existing labeling information and operating procedures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Clarification of existing labeling information and operating procedures.

Code information

Model numbers: 340066-07 - straight; 340234-02 - extended taper; 340241-03 - 5mm; 340584-01 - Gemini 8mm straight; 340586-02 - Gemini 5mm; 340725-01 - Vespa straight; 340800-01 - Gemini ext taper; 340971-01 - IS1200 Grasping 340972-01 IS2000 Grasping.

Distribution pattern

Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.

device · product 3 of 3

da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.

Z-1429-2013
Recall number
Z-1429-2013
Initiated
September 19, 2011
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
NA

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Clarification of existing labeling information and operating procedures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Clarification of existing labeling information and operating procedures.

Code information

Model number: 314850, versions 1-6

Distribution pattern

Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.