FDA Device recall Z-2498-2025
LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 33…
- FDA Device
- Class II
- ongoing
- Published 2025-09-10
On 2025-09-10 the FDA classified a Class II recall of LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 33… by Physio Control, citing due to required inspections not being performed on products/units that have gone through servicing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2498-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-22 |
| Published | 2025-09-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Physio Control |
| Distribution | US |
Product
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 monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.
Reason
Due to required inspections not being performed on products/units that have gone through servicing.
Identifiers
| code_info | Part / Catalog Numbers / UDI-DI code / Serial Number: 320371500023 / 99425-000025 / 885074698953 / 35942190 3203715002…Part / Catalog Numbers / UDI-DI code / Serial Number: 320371500023 / 99425-000025 / 885074698953 / 35942190 320371500229 / 99425-000025 / 885074698953 / 41012118 331706400001 / 99425-000025 / 885074698953 / 48988273 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Physio Control
- LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-0019…
FDA Device · Class II · 2026-05-13 · Physio Control - PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Numbe…
FDA Device · Class II · 2026-03-18 · Physio Control - LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indi…
FDA Device · Class II · 2025-09-10 · Physio Control - LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-…
FDA Device · Class II · 2025-09-10 · Physio Control - LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest
FDA Device · Class II · 2025-03-05 · Physio Control
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2498-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.