EndoWrist recallZ-0249-2020 · Intuitive Surgical, Inc. · initiated Jun 4, 2018
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Intuitive Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process change control
What the company is doing
On 06/04/2018, Medical Device Recall notices (Field Safety Notice Urgent Medical Device Correction- ISIFA2018-09-C) were emailed to U.S. consignees, and on 06/07/2018 notices were mailed via FedEx. Additionally on 06/08/2018 two (2) distributors received the notices via email and on 06/15/2018 two (2) EMEIA consignees received the notices by mail. The firm posted information regarding the voluntary field recall on their US Customer Portal on 06/04/2018. Customers were asked to: 1. Stop-use of the affected products for intra-cardiac procedures until further notice from the Recalling Firm. 2. Ensure surgeons and patient side assistants using the products have read and understand the content of the notification letter. 3. Complete the attached Acknowledgement Form and return it via fax or email to U.S. FAX +1(408)523-0619, or Scan and Email [email protected] or for further questions contact Customer Service at: -North and South America: 800-876-1310 Option 3 (4 am to 5 pm PST) -Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) 4. Please retain a copy of the Customer Notification and the Acknowledgement form on file.
Recall details
- Recall number
- Z-0249-2020
- Status
- Open, Classified
- Initiated by the company
- Jun 4, 2018
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 3108 units (518 boxes of 6 units)
- Product code
- NAY
- FDA submissions
- K162973
- Distribution
- Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom.
Product description
EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
Code information (models, lots, serial numbers)
Lots: T10180226 and onward; Part Numbers: 480299-04 (UDI 00886874114810)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EndoWrist 480299Intuitive Surgical, Inc. · System,surgical,computer controlled instrument1 recall158 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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