CLASS II Device recall · Reported 5 Jun 2013 · FDA Enforcement Report
Flush Port (used in almost all da Vinci instruments) recalled
Intuitive Surgical is recalling Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument, distributed nationwide in the US. The recall was initiated on 19 Sep 2011 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1428-2013
- FDA event ID
- 65083
- Recalling firm
- Intuitive Surgical, Sunnyvale, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Sep 2011
- FDA classified
- 29 May 2013
- Reported
- 5 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 19 Sep 2011 | Recall initiated by company | |
| 29 May 2013 | Classified by FDA | +618 days |
| 5 Jun 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Clarification of existing labeling information and operating procedures.
Product as listed by the FDA
Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
Where it was distributed
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.
Questions about this recall
Is Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument recalled?
Yes. Intuitive Surgical recalled Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument on 19 Sep 2011. The recall is Class II and its status is Terminated. Recall number Z-1428-2013.
Why was it recalled?
Clarification of existing labeling information and operating procedures.
Which lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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