Recall Z-2498-2025 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control, Inc.
LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. ECG monitorin
| Date | Sep 2, 2025 (initiated Jul 22, 2025) |
| Status | Open, Classified |
| Reason | Due to required inspections not being performed on products/units that have gone through servicing. |
| Root cause | Under Investigation by firm |
| Action | On 07/22/2025, the firm sent via certified mail an "URGENT: Medical device recall" Letter to customers informing them that, Stryker discovered a subset of work orders performed between August 10th 2022 and October 30th 2023 with Performance Inspection Procedures (PIP) recorded as PASS without the corresponding objective evidence properly documented in the work order to ensure the devices are performing as intended. Customers are instructed to: 1. Immediately check their inventory to locate the affected product as listed in the letter. 2. On the business reply form, customer need to indicate i |
| Quantity | 3 units |
| Distribution | U.S. Nationwide distribution in the states of CO and MT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.