Recall StatusOpen, Classified
Date Initiated2025-09-18
Product Quantity1,291,165 units
Reason for Recall
Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
Firm Action
On September 18, 2025, HeartSine (Stryker) issued a "Urgent: Medical Device Recall Notification." HeartSine is asking consignees to take the following actions:
1. To ensure the device works correctly in an emergency, follow the instructions within the customer notification.
A. Check the expiry date on your Pad-Pak
B. Check for bent locator pins.
C. Follow Pad-Paks insertion instructions.
D. Submit your response online at: heartsincerecall.com. A response is required in all instances.
E. Maintain Awareness
F. If you have further distributed affected product(s), please forward a copy of this notice to the new responsible party and email
[email protected] with both the location to which the product(s) was/were further distributed to and the quantity and lot number for any Pad-Paks that have been disposed of.
If you have any questions or concerns, please contact Stryker Customer Service at +1 800 787 9537, option 2, from 8:00 AM to 7:00 PM (Eastern Time), Monday Friday, or HeartSine Technologies Technical Support at
[email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution. Worldwide distribution to 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, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.