Recall Z-2161-2026 ยท DRM Compressor, Cardiac, External
Jolife AB
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 acut
| Date | May 11, 2026 (initiated Apr 13, 2026) |
| Status | Open, Classified |
| Reason | 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). |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |