LUCAS 2 — Class II medical device recall Z-1998-2025
Ongoing recall by Jolife AB, reported 2025-07-02, distributed nationwide. Due to demonstration units of chest compression system being provided to a customer which may potentially be u
| Recall number | Z-1998-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jolife AB, Lund, Sweden |
| Recall initiated | 2025-05-21 |
| Classified | 2025-06-20 |
| Reported by FDA | 2025-07-02 |
| Distributed | Nationwide (US) |
| Quantity | 5 units |
| UPC / GTIN / UDI-DI | 00883873834329, 00883873861875, 00883873904565 |
| Serial numbers | 30090111, 35160570, 35172335, 3518A164, 3518D104 |
| Model numbers | 21331-000081, 94576-000005, 99576-000025 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1998-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.