# FDA recall Z-1286-2024

> **InfuTronix LLC** · Class I · device recall initiated 2024-02-21.

## 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.

## Distribution

Domestic US distribution nationwide. No international distribution.

## Key facts

- **Recall number:** Z-1286-2024
- **Recalling firm:** InfuTronix LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-21
- **Report date:** 2024-04-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Natick, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1286-2024

## Citation

> AI Analytics. FDA recall Z-1286-2024. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-1286-2024. Source: US FDA. Licensed CC0.

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