Z-0249-2020 Class II Ongoing
FDA device recall Z-0249-2020 was initiated by Intuitive Surgical, Inc. on Jun 4, 2018 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 3108 units (518 boxes of 6 units).
Recall Details
- Product Type
- Devices
- Report Date
- Nov 6, 2019
- Initiation Date
- Jun 4, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3108 units (518 boxes of 6 units)
Product Description
EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
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.
Distribution Pattern
Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom.
Code Information
Lots: T10180226 and onward; Part Numbers: 480299-04 (UDI 00886874114810)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0249-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026