Recall Record

Lund, Sweden

Jolife AB recalls

2 recalls recorded since 2018, most recently on 13 April 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
13 April 2026
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).
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.
Initiated
Voluntary: Firm initiated
Recall number
Z-2161-2026

Ongoing Class II Medical devices

Recall started
21 May 2025
Reason
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.
Initiated
Voluntary: Firm initiated
Recall number
Z-1998-2025

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.