Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Nimbus II Infusion System Recalled by InfuTronix LLC Due to InfuTronix is removing the Nimbus Infusion Pump Systems...

Date: February 21, 2024
Company: InfuTronix LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact InfuTronix LLC directly.

Affected Products

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

Quantity: 52,328 total

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About InfuTronix LLC

InfuTronix LLC has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report