# FDA recall Z-1822-2024

> **Fresenius Medical Care Holdings, Inc.** · Class II · device recall initiated 2024-04-08.

## Product

Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure  Product Code: F30000163

## Reason for recall

Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red)  technical failure, flow measurement  during use of the Novalung system.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1822-2024
- **Recalling firm:** Fresenius Medical Care Holdings, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-08
- **Report date:** 2024-05-22

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1822-2024

## Citation

> AI Analytics. FDA recall Z-1822-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1822-2024. Source: US FDA. Licensed CC0.

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