InfuTronix LLC recalls
Every recall we track for InfuTronix LLC — 4 in all, from 2019–2024 — plus the complaints and injury reports the public filed about them. 2 are rated “stop using now”.
Recalls per year, by danger level
4 recalls since 2017.
All FDA recall records for InfuTronix LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 1 | 0 | 1 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 2 | 0 | 0 | 0 | 2 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled InfuTronix LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All InfuTronix LLC recalls
3 shown- Stop using nowMedical device
InfuTronix LLC recalls Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025.
InfuTronix recalls Nimbus Administration Set, Nimbus Flex, and Nimbus PainPro infusion pumps due to potential battery failure, system errors, and drug leakage risks. All units with catalog number IT1025 are affected and will no longer be available after June 20, 2024.
InfuTronixFeb 21, 2024 - Lower riskMedical device
InfuTronix LLC recalls Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP,
InfuTronix recalls Nimbus PainPro Ambulatory Infusion Pumps with software version v4 (Model IT1072) sold as kits IT1075-DUKE-HSP, IT1076-DUKE-HSP, and IT1077-DUKE-HSP. Unreleased Version 4 Protocol Library may impact patient safety if used on patients.
InfuTronixOct 19, 2021 - Lower riskMedical device
InfuTronix LLC recalls Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a
InfuTronix recalls Nimbus Administration Sets (REF HS-004) with specific lot numbers due to potential tube leakage during fluid administration. Affected units may cause medication or fluid leaks.
InfuTronixMay 28, 2019
InfuTronix LLC recall questions
How many recalls has InfuTronix LLC had?
4 recalls from InfuTronix LLC are on record with U.S. safety agencies, from 2019–2024.
What is the most recent InfuTronix LLC recall?
InfuTronix LLC recalls Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025., dated Feb 21, 2024. Every InfuTronix LLC recall is listed on this page, newest first.
What should I do if I have a recalled InfuTronix LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new InfuTronix LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.