EndoWrist Suction Irrigator — Class II medical device recall Z-0249-2020
Ongoing recall by Intuitive Surgical, Inc., reported 2019-11-06, distributed nationwide. The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator dev
| Recall number | Z-0249-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2018-06-04 |
| Classified | 2019-10-30 |
| Reported by FDA | 2019-11-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CH, GB, IT |
| UPC / GTIN / UDI-DI | 00886874114810 |
| Lot numbers | T10180226 |
| Model numbers | 480299-04 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0249-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.