LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Num

FDA device recall Z-2161-2026 · posted 2026-05-11 · Open, Classified

Recall details

Recalling firm

Jolife AB

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).

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

DRM

Quantity affected

153 systems

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.

Date initiated

2026-04-13

Date posted

2026-05-11

Location

Lund, Sweden

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