EndoWrist Suction Irrigator recall
EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
Why was EndoWrist Suction Irrigator recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: T10180226 and onward; Part Numbers: 480299-04 (UDI 00886874114810)
- Product
- EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 3108 units (518 boxes of 6 units)
- Distribution
- Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom.
- Recall date
- November 6, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)