Intuitive Surgical Recalls da Vinci Flush Ports for Labeling Clarification
Intuitive Surgical is recalling da Vinci instrument flush ports to clarify existing labeling and operating procedures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is for a labeling clarification, which aligns with the rubric criterion for 'Minor labeling errors' or 'voluntary precautionary recalls' classified as Moderate.
Plain-English summary
Intuitive Surgical, Inc. is recalling Flush Ports used in almost all da Vinci instruments. These components assist in cleaning the instruments. The recall involves specific model numbers including 340066-07, 340234-02, 340241-03, 340584-01, 340586-02, 340725-01, 340800-01, 340971-01, and 340972-01.
The reason for the recall is the clarification of existing labeling information and operating procedures. The agency has classified this as a Class II recall. The products were distributed worldwide, including in the United States and various international locations such as Argentina, Australia, Canada, and China.
No specific instructions for consumers are provided in the source text beyond the nature of the labeling clarification. Healthcare facilities and users of these instruments should refer to the manufacturer for updated labeling and operating procedures.
The recalled product
- Product
- Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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