FDA Device recall Z-1102-2025
LIFEPAK 35 ECG cable REF 11111-000041
- FDA Device
- Class II
- ongoing
- Published 2025-02-12
On 2025-02-12 the FDA classified a Class II recall of LIFEPAK 35 ECG cable REF 11111-000041 by Physio Control, citing product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1102-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-21 |
| Published | 2025-02-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Physio Control |
| Distribution | US |
Product
LIFEPAK 35 ECG cable REF 11111-000041
Reason
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
Identifiers
| code_info | Catalog Number: 11111-000041 UDI-DI code: 00883873834596 Lot/Serial Number: 0224 |
|---|
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 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 33…
FDA Device · Class II · 2025-09-10 · Physio Control
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1102-2025%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.