FDA Device recall Z-0249-2020
EndoWrist Suction Irrigator, Single Use Instrument
- FDA Device
- Class II
- ongoing
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class II recall of EndoWrist Suction Irrigator, Single Use Instrument by Intuitive Surgical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0249-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-06-04 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
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.
Identifiers
| code_info | Lots: T10180226 and onward; Part Numbers: 480299-04 (UDI 00886874114810) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0249-2020%22
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