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LUCAS CHEST COMPRESSION SYSTEM recallZ-2161-2026 · Jolife AB · initiated Apr 13, 2026

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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 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).

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected] 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 [email protected].

Recall details

Recall number
Z-2161-2026
Status
Open, Classified
Initiated by the company
Apr 13, 2026
Posted by the FDA
May 11, 2026
Recalling firm
Jolife AB
Quantity
153 systems
Product code
DRM
FDA submissions
K090422, K161768
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.

Product description

LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 00883873834329 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)

Show the full code information (2k characters)

LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 Serial Numbers: 30100846 30112125 30123845 30124348 30124440 30124475 30124991 30136605 30148155 30148365 3015B568 3015B682 3015C276 3015C722 3015C723 3015C724 3015F246 3015F587 3016G845 3016H983 3017K078 3017K079 3017K080 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 Serial Numbers: 35160778 35173272 35173461 35185820 35185817 35175040 35175039 35173347 35160921 35175373 35174279 35172701 35161449 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 00883873834329 Serial Numbers: 3520R763 3522AN95 3519F615 3520N419 3522DK48 3521S574 3521T901 3520R187 3518B300 3522EG06 3520P749 3520R206 3520S005 3520P512 3520P691 3520P741 3520P742 3520P744 3520P745 3520P746 3520P748 3520P810 3520S006 3520P747 3520S003 3521AF21 3518B131 3520L408 3519E743 3521AC18 3521U379 3520O364 3520S292 3519F035 3520S149 3521Z495 3521Z496 3520P082 3520L957 3520R180 3519G235 3519G633 3519H568 3519E607 3522BI32 3518D028 3522CN47 3520K867 3519I425 3520K923 3523FA45 3520O771 3520R123 3521W020 3520K966 3522AV78 3521T568 3520O776 3518A707 3521T325 3521T329 3518C485 3518D396 3522BU41 3519G180 3522AR04 3522AR05 3520R135 3522CR96 3523EN71 3520R209 3520L915 3520L916 3520N979 3520O026 3520O298 3520P109 3520P559 3520S287 3521V691 3522AR01 3522AR03 3518D017 3519E728 3520N729 3519F039 3520L676 3520N364 3520N366 3521S486 3520P539 3521V200 3522BZ70 3523FL02 3523FL03 3521T704 3521T575 3520O549 3520P906 3520P928 3520P930 3522AR07 3520R138 3523EN74 3521V688 3519F034 3523FA47 3520P907 3520S285 3521S487 3522AR00 3522AR06 3523FD33 3519F038 3523FH21 3520N010 3520N505

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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