Data Foundry

Medical device recalls 2026

LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and… — Class II medical device recall Z-2161-2026

Ongoing recall by Jolife AB, reported 2026-05-20, distributed nationwide. Due to a subset of chest compression systems/devices where the service performed on the systems were not appro

Recall numberZ-2161-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmJolife AB, Lund, Sweden
Recall initiated2026-04-13
Classified2026-05-11
Reported by FDA2026-05-20
DistributedNationwide (US)
Quantity153 systems
UPC / GTIN / UDI-DI00883873834329, 00883873861875, 00883873904565
Serial numbers30100846, 30112125, 30123845, 30124348, 30124440, 30124475, 30124991, 30136605, 30148155, 30148365, 3015B568, 3015B682, 3015C276, 3015C722, 3015C723, 3015C724, 3015F246, 3015F587, 3016G845, 3016H983, 3017K078, 3017K079, 3017K080, 35160778, 35160921 and 128 more
Model numbers99576, 99576-000011, 99576-000024, 99576-000043, 99576-000063

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 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).

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-2161-2026. 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.