Intuitive Surgical Recalls da Vinci SP Cameras Due to Residual Soil
Intuitive Surgical is recalling 305 da Vinci SP cameras because residual soil on the tip may affect image quality or cause patient sensitization.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (sensitization, scar tissue) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Intuitive Surgical, Inc. is recalling 305 units of the da Vinci SP Camera (Model Number: 430060-33) used for endoscopic surgery. The recall was initiated because some cameras were found to have residual soil adhered to the tip after reprocessing.
The presence of residual soil may affect image quality, potentially requiring surgeons to switch to a second camera or convert to another surgical modality. If the residual soil makes contact with the patient, it could result in sensitization, making future component blood therapy or tissue typing more challenging. Additionally, if a small piece of inert epoxy were retained, scar tissue could form.
The affected units were distributed in the United States and South Korea. The recall includes all serial numbers for the specified model. Healthcare facilities should stop using the affected cameras and contact Intuitive Surgical for further instructions.
The recalled product
- Product
- da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 305
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 (3)
- Model Number: 430060-33
- UDI Number: 00886874114384
- All serial numbers.
Distribution
Distributed nationwide across the United States.
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