Nimbus II Infusion System — Class I medical device recall Z-1286-2024
Ongoing recall by InfuTronix LLC, reported 2024-04-03, distributed nationwide. InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure mode
| Recall number | Z-1286-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | InfuTronix LLC, Natick, MA, United States |
| Recall initiated | 2024-02-21 |
| Classified | 2024-03-28 |
| Reported by FDA | 2024-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 52,328 total |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00817170020017, 00817170020024, 00817170020031, 00817170020048, 00817170020086, 00817170020093, 00817170020109, 00817170020123, 00817170020161, 00817170020376 |
| Lot numbers | A100G-170420044, A100G-170512429, AGZ049-170512429, AGZ049-170615116, AGZ049-170816391, AGZ049-170829480, AGZ049-1709071188, AGZ049-171027828, AGZ049-1712011824, AGZ049-171229744, AGZ049-1806091272, AGZ049-180626984, AGZ049-1809201152, AGZ049-1810241536, AGZ049-181102108, AGZ049-190104504, AGZ049-190104648, AGZ049-190314768, AGZ049-1903151440, AGZ049-190515480, AGZ049-190515960, AGZ049-1906271440, AGZ049-1907231776, AGZ049-190723360, AGZ049-190806144, AGZ049-190924504, AGZ049-191023480, AGZ049-1912161920, AGZ049-200102576, AGZ049-2002251632, AGZ049-200714960, AGZ049-200828960, AGZ049-2009241440, AGZ049-2011301920, AGZ049-2103231200, AGZ049-210324360, AGZ049-210422528, AGZ049-210809480, AGZ049-211121360, AGZ049-2111222136 and 54 more |
Product
Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and components
Reason for recall
InfuTronix is removing the Nimbus Infusion Pump Systems 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. The device will not be available or supported after June 20, 2024.
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-1286-2024. 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.