LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Failure
Physio-Control is recalling LIFEPAK 15 defibrillators due to loose battery pins that may cause power failure. Users should verify device functionality immediately.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device (defibrillator) where failure during use could be life-threatening. However, no illnesses or injuries have been reported, and the hazard is characterized as potential rather than confirmed. FDA Class II classification indicates moderate regulatory concern. Score 3 reflects the serious consequences of device failure in a cardiac emergency setting, balanced against the absence of reported harm.
Plain-English summary
Physio-Control, Inc. is recalling the LIFEPAK 15 defibrillator (Model 99577-000061, Part Number V15-2-000067) nationwide. The recall affects units distributed in Arizona, California, North Carolina, New Jersey, and New York.
The defibrillator may experience power failure due to loose battery pins within the device. This could prevent the unit from functioning when needed in a cardiac emergency.
The affected unit has Serial Number 38166543 (UDI: 00883873979358). No injuries or illnesses have been reported to date.
Users should verify the functionality of their LIFEPAK 15 devices and contact Physio-Control for guidance on inspection or replacement.
The recalled product
- Product
- LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 00883873979358/ Serial number: 38166543
Distribution
Part of a larger recall action
This product is one of 10 recalled by Physio-Control, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
Same manufacturer · Physio-Control, Inc.
See all →- HighPhysio-Control Defibrillators May Lack Required Performance Inspection
FDA (Devices) · 2026-05-13
- HighInfant and child defibrillator electrodes recalled over pediatric electrode delamination
FDA (Devices) · 2026-03-18
- ModerateDefibrillator recalled because required post-service inspections were not performed
FDA (Devices) · 2025-09-10
- ModerateLIFEPAK 15 defibrillators recalled because post-service inspections were not performed
FDA (Devices) · 2025-09-10
- ModerateLIFEPAK 1000 defibrillators recalled over inspections missed after unit servicing
FDA (Devices) · 2025-09-10
Same hazard · battery malfunction
See all →- CriticalLife2000 Ventilation System battery charger defect causes device inoperability
FDA (Devices) · 2025-01-22
- SevereAmbulatory Infusion System Batteries May Short Circuit and Overheat
FDA (Devices) · 2024-11-06
- HighLIFEPAK 15 Defibrillator Recalled for Loose Battery Pins Causing Power Loss
FDA (Devices) · 2023-11-22
- HighLIFEPAK 15 Defibrillators Recalled Due to Potential Loose Battery Pins
FDA (Devices) · 2023-11-22
- SevereArrow AC3 Optimus IABP Devices Recalled for Short Battery Run-Time Issue
FDA (Devices) · 2022-12-21