Stop using nowMedical device recall · FDA · Published February 21, 2024
InfuTronix Nimbus Infusion Pumps Recalled Due to Battery and System Failure Risks
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.
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.
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Contact the company
📍Recalling firmInfuTronix LLC177 Pine St · Natick, MA 01760-1331
✎ GovInfoNow plain-language explainer
InfuTronix is recalling Nimbus Administration Set, Nimbus Flex, and Nimbus PainPro infusion pumps because they can fail in multiple ways, including battery issues, system errors, and drug leakage. This poses a risk of serious injury or death if the device malfunctions during use. Read more at govinfonow.com/recall/56129-infutronix-nimbus-infusion-pumps-recalled-due-to-battery-and-system.
“InfuTronix Nimbus Infusion Pumps Recalled Due to Battery and System Failure Risks.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56129-infutronix-nimbus-infusion-pumps-recalled-due-to-battery-and-system. Based on FDA recall #Z-1285-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1285-2024%22&limit=1).
The FDA announced on Feb. 21, 2024, that InfuTronix LLC is recalling Nimbus infusion pump systems due to potential failure modes including battery failure and drug leakage. The agency classified the recall as Class I.
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.
Context
GovInfoNow's records show InfuTronix LLC has two other recalls on record since May 28, 2019. On Oct. 19, 2021, the company recalled Nimbus PainPro Pumps with v4 Software because an unreleased protocol library may impact patient safety. On May 28, 2019, InfuTronix recalled the Nimbus Administration Set due to a potential tube leakage risk. Other recent recalls of similar products include Fresenius Kabi LVP-0004 Infusion Pump Recall (Feb. 4, 2026), Baxter Novum IQ Syringe Pump Recall (Aug. 11, 2026), and Fresenius Kabi Ivenix Infusion System Software Recall (May 6, 2026).
How to tell if you have this one
Check for the catalog number IT1025 on the pump or its packaging. The recalled models include Nimbus Administration Set, Nimbus Flex, and Nimbus PainPro (also known as Halo Ambulatory Infusion System).
Brand
InfuTronix
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Ongoing
Distribution
Domestic US distribution nationwide. No international distribution.
Immediately stop using the Nimbus Administration Set, Nimbus Flex, or Nimbus PainPro pumps if you have the catalog number IT1025.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Domestic US distribution nationwide. No international distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1285-2024 (February 21, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1285-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.