# FDA recall Z-1998-2025

> **Jolife AB** · Class II · device recall initiated 2025-05-21.

## Product

LUCAS 2, 3 and 3.1    LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

## Reason for recall

Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.

## Distribution

U.S. Nationwide distribution in the states of IN, MI, OH and TX.

## Key facts

- **Recall number:** Z-1998-2025
- **Recalling firm:** Jolife AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-21
- **Report date:** 2025-07-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lund, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1998-2025

## Citation

> AI Analytics. FDA recall Z-1998-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1998-2025. Source: US FDA. Licensed CC0.

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