Intuitive Surgical Recalls EndoWrist Suction Irrigator Due to Silicone Particle Risk
Intuitive Surgical is recalling EndoWrist Suction Irrigator instruments because silicone particles may form and be introduced into patients during irrigation.
What this means for you
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 is classified as FDA Class II and involves a risk-of-harm product (foreign material introduction) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Intuitive Surgical, Inc. is recalling the EndoWrist Suction Irrigator, a single-use instrument used as an accessory to the EndoWrist Surgical System for endoscopic surgery. The recall involves 3,108 units (518 boxes of 6 units) with Part Number 480299-04 and UDI 00886874114810. The affected lots include T10180226 and onward.
The firm identified a potential for silicone particles to be generated within the device. If generated, these particles may be introduced into the patient with irrigation. The recall is classified as Class II by the FDA.
The product was distributed worldwide, including the United States, Australia, Italy, Switzerland, and the United Kingdom. Healthcare providers and facilities should stop using the affected devices and contact Intuitive Surgical for further instructions.
The recalled product
- Product
- EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
- Manufacturer
- Intuitive Surgical, Inc.
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 (2)
- Lots: T10180226 and onward
- Part Numbers: 480299-04 (UDI 00886874114810)
Distribution
Distributed nationwide across the United States.
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