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InfuTronix

Country not established

Devices
11
FDA recalls
43 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue11

Newest first, rows 1-11 of 11

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Company details

Website
Infutronix.com This website did not respond in time when we last checked. Last checked 18 Oct 2026.

FDA recalls4

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 1
  • 2020 0
  • 2021 1
  • 2022 0
  • 2023 0
  • 2024 2
  • 2025 0
  • 2026 0

  • 2024

    • 21 Feb 2024 Z-1285-2024 Class I Ongoing 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. Distribution: Domestic US distribution nationwide. No international distribution. Submission numbers: K140783, K153193
    • 21 Feb 2024 Z-1286-2024 Class I Ongoing 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. Distribution: Domestic US distribution nationwide. No international distribution. Submission numbers: K140783, K153193

  • 2021

    • 19 Oct 2021 Z-0832-2022 Class II Ongoing An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients. Distribution: US Nationwide distribution in the states of NC and OH. Submission number: K153193

  • 2019

    • 28 May 2019 Z-2055-2019 Class II Terminated Potential for tube leakage Distribution: US distribution in the state of MA Submission numbers: K140792, K153193

Frequently asked questions

How many devices does InfuTronix have in the registry?

The registry currently lists 11 devices for InfuTronix. Devices recorded under merged duplicate company entries are counted once.

Which registries list InfuTronix's devices?

Among its 11 most recently registered devices, InfuTronix has devices listed in FDA GUDID (11 devices).

What risk classes do InfuTronix's devices fall under?

Among its 11 most recently registered devices, the classes recorded for InfuTronix's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for InfuTronix?

FDA recall records list 4 recalls initiated by InfuTronix, the most recent initiated on 21 Feb 2024. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from InfuTronix in the registry?

The most recently registered devices listed for InfuTronix include Nimbus II PainPRO, Nimbus Hard Shell 100ml, Nimbus and Nimbus II Plus.

Generated automatically from registry data and not verified by a human reviewer.