Quick Facts at a Glance
- Recall Date
- January 21, 2026
- Hazard Level
- HIGH
- Brand
- Physio-Control
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- CHILDREN, GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Physio-Control
- Product type
- Defibrillator Electrodes
- Model numbers
- Catalog Numbers: 11101-000016, Catalog Number: 11101-000017
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 21, 2026
Reported by FDA DEVICE
March 18, 2026
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Due to pediatric defibrillator electrode delamination
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Physio-Control, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
Infant/Child Reduced Energy Defibrillator Electrodes are designed for safely delivering defibrillation to young patients using AED devices. They are essential in emergency medical situations for infants and children under 8 years old or under 25 kg.
Why This Is Dangerous
The hazard arises from potential delamination of the electrode layers, which may lead to ineffective shocks in critical situations. This problem can prevent the electrodes from adhering properly and delivering the needed energy.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects 16,499 electrodes, which may leave users without an effective treatment option in emergencies. Healthcare providers and caregivers must replace recalled electrodes promptly to ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Check the catalog numbers on your electrode packaging: 11101-000016 or 11101-000017.
- Inspect for any signs of damage or delamination although the defect may not be visible.
Where to find product info
The catalog and lot numbers are typically found on the packaging of the electrodes or on the device itself where they are attached.
What timeline to expect
Refund or replacement processing typically takes 4 to 6 weeks after submission for the recall.
If the manufacturer is unresponsive
- Document all communication attempts with Physio-Control.
- Contact your healthcare provider for assistance or escalate the issue to local health authorities.
How to prevent similar issues
- Ensure that electrodes meet current safety certifications before purchase.
- Regularly check expiration dates and product recalls for medical devices.
Documentation advice
Keep records of all correspondence with the manufacturer, including emails, receipts, and photographs of the product.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Class II recall due to electrical hazard
- Immediate action required to stop use
Browse More Recalls
Safety Guide
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