Jolife AB recalls LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI co…

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).

On 04/13/2026, the firm sent via US Postal an "Urgent: Medical device correction" letter informing customers that through complaint reviews, Stryker discovered a subset of work orders performed between July 2023 through November 2025 with Performance Inspection Procedures (PIP) recorded as PASS without the corresponding objective evidence properly documented in the work orders. Customers are instructed to: 1. Immediately check internal inventory to locate the affected product as listed. 2. Return the business reply form by email to RSRecall@Stryker.com to confirm receipt of this notification. 3. Upon receipt of the completed business reply form, Stryker will contact customers to arrange for corrective action on the device if service has not been performed. 4. There are no additional actions that users can and should take. Continue to follow the Operating Instructions and perform the daily checks and user tests. These tests can be found in the chapter Maintaining the Equipment subsection General Maintenance and Testing . 5. Maintain awareness of this communication internally until all required actions have been completed within their facility. Ensure this letter is kept with the affected device until the correction has been completed. 6. 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 medtechsup@stryker.com.

• FDA enforcement recordOfficial FDA database entry for Z-2161-2026
• FDA 510(k) clearance · K090422The device's official FDA premarket clearance record
• FDA 510(k) clearance · K161768The device's official FDA premarket clearance record
• FDA device classification · DRMOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.5200The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Jolife ABSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.