FDA recall, , Moderate risk
Jolife LUCAS Chest Compression System
LUCAS chest compression systems may have service records that do not justify passing results.
Summary by Recall Canary from the FDA notice
What happened
Jolife AB of Lund, Sweden, is recalling LUCAS chest compression systems because a subset of the systems had service performed that was not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).
The recall affects 153 systems, including the LUCAS 2 Model Number 99576, LUCAS 3 Model Number 99576, and LUCAS 3.1 Model Number 99576, which are used for performing external cardiac compressions on adult patients who have acute circulatory arrest.
The recall began on April 13, 2026, and was added to the FDA's Enforcement Report on May 11, 2026. The systems were distributed nationwide in the United States across 21 states, including Alabama, Arizona, California, Florida, Hawaii, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, Nevada, Ohio, South Carolina, Texas, Utah, Virginia, Washington, and Wyoming.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number or UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
LUCAS 2
- Model
- 99576
Catalog Numbers: 99576-000024 and 99576-000011
- UDI-DI
- 00883873904565
Catalog Number: 99576-000043
- UDI-DI
- 00883873861875
Catalog Number: 99576-000063
- UDI-DI
- 00883873834329
Recall details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the states of Alabama, Arizona, California, Florida, Hawaii, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, Nevada, Ohio, South Carolina, Texas, Utah, Virginia, Washington, and Wyoming.
- Company
- Jolife ABLund, Sweden
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98417
- Recall number
- Z-2161-2026
- Quantity recalled
- 153 systems
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
