Physio-Control Infant/Child Defibrillator Electrodes
Physio-Control is recalling infant/child defibrillator electrodes due to a risk of delamination that could impact therapy delivery.
Immediately stop using the affected electrodes and contact Physio-Control or your authorized distributor for replacement instructions.
Recall at a glance
- Quantity recalled
- 16,499 electrodes (US/OUS: 8327/8172)
Why it was recalled
Physio-Control is recalling specific infant and child reduced energy defibrillator electrodes due to potential delamination of the electrode, which may prevent effective therapy delivery. The affected products were distributed nationwide.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UDI-DI |
|---|---|
| PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow hands free defibrillation. These electrodes reduce the energy delivered to the patient by a factor of 4:1. The Infant/child reduced energy defibrillation electrodes are therapy electrodes desig | 00721902629013, 00721902682483 |
| Catalog Numbers: 11101-000016 | 00721902629013 |
| Catalog Number: 11101-000017 | 00721902682483 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from Physio-Control, Inc.
Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification