Recall Z-2065-2026 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control, Inc.
LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045; LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096; LIFEPAK 35, REF: 99335-000013, 99335-000
| Date | May 4, 2026 (initiated Apr 13, 2026) |
| Status | Open, Classified |
| Reason | Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy. |
| Root cause | Process control |
| Action | On 04/13/2026, recall notices were sent to customers who were asked to do the following: 1) Return the business reply form by email to RSRecall@Stryker.com to confirm receipt of this notification. 2) Upon receipt of the completed business reply form, firm will contact you to arrange for corrective action on the device if service has not been performed. 3) 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". 4) Maintain awareness of this communi |
| Quantity | 206 |
| Distribution | US Nationwide distribution in the states of MI, WA, KY, IN, FL, NC, TX, LA, VA, NY, MA, CO, PA, OH, SC, OK, MN, WV, NJ, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.