Recall Z-2161-2026— Jolife AB

Name: FDA recall Z-2161-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-13

Class II · Ongoing

Class II FDA medical device recall by Jolife AB, initiated 2026-04-13. It names 2 FDA 510(k) clearances: K161768, K090422. Product: LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 00883873834329 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: Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records)..

Recalling firm: Jolife AB
Classification: Class II
Status: Ongoing
Initiated: 2026-04-13
Firm location: Lund, Sweden

510(k) clearances named in this recall

2 on FDA's record

K161768 — LUCAS 3 Chest Compression SystemJolife AB·cleared 2016-11-09
K090422 — LUCAS 2Jolife AB·cleared 2009-06-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 00883873834329 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 a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).

Data sourced from openFDA. This site is unofficial and independent of the FDA.