Quick Facts at a Glance
- Recall Date
- September 18, 2025
- Hazard Level
- HIGH
- Brand
- HeartSine Technologies
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- 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
- HeartSine Technologies
- Product type
- Pad-Pak Defibrillator Pads
- Model numbers
- PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 18, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact HeartSine Technologies Ltd or your healthcare provider for instructions. Notification method: Letter
About This Product
Pad-Pak defibrillator pads are electrode pads used with HeartSine Samaritan PAD devices to deliver external defibrillation in emergencies.
Why This Is Dangerous
Damaged pins can impair the pad’s fit and electrical contact, reducing the effectiveness of defibrillation.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
No injuries have been reported yet. Immediate discontinuation of use is required to avoid potential device failure during emergencies.
Practical Guidance
How to identify if yours is affected
- Inspect Pad-Pak pads for model numbers PAD-PAK-01 to PAD-PAK-04J
- Compare your pads to the recall list
- Contact HeartSine for instructions on replacement or refunds
Where to find product info
Refer to the FDA recall page and manufacturer guidance for exact identification details
What timeline to expect
Remedies such as replacement pads or refunds are typically processed within weeks to months depending on manufacturer programs
If the manufacturer is unresponsive
- Document all correspondence and dates
- Escalate to consumer protection offices if there is no response within a reasonable time
- Consider filing a report with CPSC if the situation involves consumer safety risk
How to prevent similar issues
- When buying AED accessories, verify compatibility with your device model
- Check for recalls via FDA or manufacturer notices
- Look for pads with intact connectors and no visible damage
Documentation advice
Keep the recall notice, model numbers, lots, UDIs, correspondence with the manufacturer, and any receipts or proof of purchase
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model numbers: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J. Sold in the United States nationwide and distributed worldwide to countries including Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Qatar
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 2. PAD-PAK models: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-
- 4. Distribution: US nationwide and worldwide
- 5. No injuries reported
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
