Physio-Control Recalls LIFEPAK 15 Defibrillators Due to Relay Failure
Physio-Control is recalling 338 LIFEPAK 15 defibrillators because an internal relay may fail, preventing the device from delivering defibrillation energy.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (Relay) installed on the Therapy Printed Circuit…"
Plain-English summary
Physio-Control, Inc. is recalling 338 units of the LIFEPAK 15 Monitor, Automated External Defibrillator (AED). The recall involves 139 units in the United States and 199 units distributed internationally.
The firm identified a potential issue where the device may no longer be able to deliver defibrillation energy. This is caused by a potential failure of an internal component, specifically a Relay installed on the Therapy Printed Circuit Board Assembly (PCBA). The device is intended for use on adult and pediatric patients in manual mode, and for patients eight years of age and older in automated mode.
Affected units are distributed nationwide in the US and in numerous countries including Australia, Brazil, Canada, and the United Kingdom. Consumers and healthcare facilities should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- Product
- LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
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 (20)
- SERIAL NUMBERS: 42738872
- 44554102
- 42701550
- 42702539
- 42730815
- 42800549
- 42803986
- 42862109
- 42884428
- 42944609
- 42989327
- 43022460
- 43040692
- 43048791
- 43066974
- 43116838
- 43116994
- 43119477
- 43132954
- 43133203
Distribution
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 1000 defibrillators recalled over inspections missed after unit servicing
FDA (Devices) · 2025-09-10
- ModerateLIFEPAK 15 defibrillators recalled because post-service inspections were not performed
FDA (Devices) · 2025-09-10
Same hazard · device failure
See all →- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
Similar recalls
- HighPhysio Control Recalls LIFEPAK 500 AEDs Due to Assembly Error
FDA (Devices) · 2013-07-31
- HighPhysio-Control Recalls LIFEPAK 15 Monitor/Defibrillators for Unexpected Power Loss
FDA (Devices) · 2016-12-21
- SeverePhysio-Control Recalls LIFEPAK AEDs Due to Shock Delivery Failure Risk
FDA (Devices) · 2016-07-06
- HighPhysio-Control Recalls LifePAK 500 AEDs Due to Contact Plating Wear
FDA (Devices) · 2020-04-08
- SeverePhysio-Control Recalls LIFEPAK 20e Defibrillators Due to Power Failures
FDA (Devices) · 2018-01-17
- HighPhysio-Control Recalls LIFEPAK 1000 Defibrillators Due to Unexpected Shutdowns
FDA (Devices) · 2014-06-04