LUCAS CHEST COMPRESSION SYSTEM recallZ-1998-2025 · Jolife AB · initiated May 21, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Jolife AB or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.
FDA root cause category: Employee error
What the company is doing
On 05/21/2025, the firm send via certified mail an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that demonstration LUCAS devices were given to customers for use without the proper labeling. These demonstration units are not maintained in a clinically usable state and are not to be loaned to customers or used in a clinical setting. Customer are instructed to: 1. Immediately check their internal inventory to locate the product listed on the attached business reply form, stop usage, and remove them from their point of use. 2. Return the enclosed business reply form by email to [email protected] to confirm receipt of this notification. 3. Upon receipt of the completed business reply form, Stryker will contact customers to arrange for the return and replacement of the affected product(s). 4. Maintain awareness of this communication internally until all required actions have been completed within their facility. Keep this communication close to the affected items until replacement. 5. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients appropriately. Any questions or concerns, contact Customer Service +1 800 787 9537, option 2, from 8:00 AM to 7:00 PM (Eastern Time), Monday Friday or by email at [email protected].
Recall details
- Recall number
- Z-1998-2025
- Status
- Open, Classified
- Initiated by the company
- May 21, 2025
- Posted by the FDA
- Jun 20, 2025
- Recalling firm
- Jolife AB
- Quantity
- 5 units
- Product code
- DRM
- FDA submissions
- K161768, K090422
- Distribution
- U.S. Nationwide distribution in the states of IN, MI, OH and TX.
Product description
LUCAS 2, 3 and 3.1 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.
Code information (models, lots, serial numbers)
Lucus 2 Catalog Number: 99576-000025 UDI-DI code: 00883873904565 Serial Number: 30090111 Lucas 3 Catalog Number: 21331-000081 UDI-DI code: 00883873861875 Serial Numbers: 35172335 35160570 Lucas 3.1 Catalog Number: 94576-000005 UDI-DI code: 00883873834329 Serial Numbers: 3518A164 3518D104 (Scrapped)
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- LUCAS 99576Jolife AB · Compressor, cardiac, external2 recalls9 deaths99 reports
- LUCAS™ Chest Compression System 99576Jolife AB · COMPRESSOR, CARDIAC, EXTERNAL2 recalls7 deaths36 reports
- LUCAS™ CHEST COMPRESSION SYSTEM 99576Jolife AB · Compressor, cardiac, external2 recalls15 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page