Jolife Ab Scheelevagen 17 Ideon Science Park Lund Sweden: Compressor, Cardiac, External

Recall Summary Jolife AB is recalling LUCAS 2, LUCAS 3, and LUCAS 3.1 chest compression devices used to perform CPR on cardiac arrest patients. The recall affects devices where maintenance documentation was not properly recorded, meaning service work performed on the devices cannot be verified. The affected devices were distributed nationwide across the United States.

Recalling firm
Jolife AB Scheelevagen 17 Ideon Science Park Lund Sweden
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).
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-04-13
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
U.S. Nationwide distribution in the states of AL, AZ, CA, FL, HI, IA, KS, KY, LA, MA, MD, MN, NC, NV, OH, SC, TX, UT, VA, WA, and WY.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/eea5fa24-59a7-4dcb-b6e9-feaab622bc21