FDA Medical Device Recalls (openFDA)
Intuitive Surgical, Inc.: EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
- Recall number
- Z-0249-2020
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
- Status
- Open, Classified
- Initiated
- 2018-06-04
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process change control
- Action
- 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 Recalls@intusurg.com 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.
- Quantity
- 3108 units (518 boxes of 6 units)
- Distribution
- Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom.
- Lot, serial or model codes
- Lots: T10180226 and onward; Part Numbers: 480299-04 (UDI 00886874114810)
- 510(k) numbers
- ["K162973"]
- PMA numbers
- not on file
- Product code
- NAY
- Firm FEI
- 3001675293
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28