Z-0249-2020Class II

EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist...

Name: Z-0249-2020 EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist...
Creator: Intuitive Surgical, Inc.
Published: 2018-06-04
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2018-06-04 / Open, Classified

FDA source

Intuitive Surgical, Inc. began a recall of EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery on 2018-06-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0249-2020
Classification: Class II
Status: Open, Classified
Initiated: 2018-06-04
Posted: 2019-10-30
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.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: 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: 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 [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.
Quantity in commerce: 3108 units (518 boxes of 6 units)
Distribution: Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom.
Product codes and lots: Lots: T10180226 and onward; Part Numbers: 480299-04 (UDI 00886874114810)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0249-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0249-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-11-06	2019-10-30

Product code NAY

K162973Class IIEndoWrist Suction IrrigatorIntuitive Surgical, Inc. / cleared 2017-02-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)