Optum Nimbus II Plus — Class I medical device recall Z-1811-2024
Ongoing recall by OptumHealth Care Solutions LLC, reported 2024-05-29, distributed nationwide. Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due t
| Recall number | Z-1811-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | OptumHealth Care Solutions LLC, Marietta, GA, United States |
| Recall initiated | 2024-04-18 |
| Classified | 2024-05-20 |
| Reported by FDA | 2024-05-29 |
| Distributed | Nationwide (US) |
| Quantity | 208 units |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00862492000308 |
| Serial numbers | 302604, 318050, 340086, 340163, 340648, 340746, 340820, 340903, 341046, 341372, 341535, 341757, 341770, 342136, 342233, 342350, 342447, 342938, 343066, 343309, 343683, 344023, 344044, 344173, 344273 and 391 more |
| Model numbers | AAA-00170 |
Product
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
Reason for recall
Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing.
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-1811-2024. 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.