medical Class II Updated 2019-11-06

Intuitive Surgical, Inc. recalls EndoWrist Suction Irrigator, Single Use Instrument. Part Nu

Recalled Product

EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.

Hazard / Issue

The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lots: T10180226 and onward; Part Numbers: 480299-04 (UDI 00886874114810)
View official government recall

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