Official recall notice
FDA DeviceClass IINotable
FDA Recall: PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016
- Recall date
- 2026-03-18
- Brand
- Physio-Control, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Due to pediatric defibrillator electrode delamination
Recommended action
What to do
16,499 electrodes (US/OUS: 8327/8172)
Product description
Due to pediatric defibrillator electrode delamination