Ion Endoluminal System — Class II medical device recall Z-2720-2024
Ongoing recall by Intuitive Surgical, Inc., reported 2024-09-04, distributed nationwide. There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fai
| Recall number | Z-2720-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2024-07-12 |
| Classified | 2024-08-23 |
| Reported by FDA | 2024-09-04 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| UPC / GTIN / UDI-DI | 00886874116234 |
| Serial numbers | EN1230/10591271, EN1231/10583014, EN1241/10591273 |
| Model numbers | 380748-65 |
Product
Ion Endoluminal System, REF: 380748-65
Reason for recall
There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.
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-2720-2024. 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.