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RECALL NOTICE: Stryker HeartSine/Samaritan PAD-PAK Accessories

URGENT SAFETY NOTICE -  STRYKER HAS ISSUED A VOLUNTARY RECALL FOR HEARTSINE SAMARITAN PAD-PAK-01, PAD-PAK-02, AND PAD-PAK-07 AED ACCESSORIES WITH EXPIRATION DATES BETWEEN APRIL 17, 2025, AND AUGUST 1, 2029. THIS RECALL AFFECTS UNITS IN THE UNITED STATES DUE TO POTENTIAL BENT LOCATOR PIN DEFECTS THAT MAY PREVENT PROPER DEVICE OPERATION DURING EMERGENCY USE. MEDAIRE HAS IMPLEMENTED COMPREHENSIVE INSPECTION PROTOCOLS FOR ALL HEARTSINE UNITS SHIPPING AFTER OCTOBER 6, 2025.

UPDATED: November 4, 2025

Recall Overview

Stryker has issued an urgent voluntary recall affecting HeartSine Samaritan PAD-PAK-01, PAD-PAK-02, and PAD-PAK-07 accessories used in Automated External Defibrillators (AEDs). 

Affected Products:

  • PAD-PAK-01, PAD-PAK-02, and PAD-PAK-07 accessories
  • Expiration dates: April 17, 2025, through August 1, 2029
  • Issue: Potential bent locator pins preventing proper device operation and therapy delivery
  • Regulatory notification: U.S. Food and Drug Administration, Medicines and Healthcare products Regulatory Agency and the French National Agency for the Safety of Drugs and Healthcare Products have been officially notified.

MedAire's Proactive Response

For customers with units shipped October 6, 2025, and later: No action required. MedAire has implemented comprehensive inspection protocols for all PAD-PAKs installed in HeartSine units shipping from our facilities. Your equipment has been verified for compliance before shipment.

Required Actions for Existing Equipment

Option 1: Self-Inspection

Follow the detailed instructions in the manufacturer's official notifications to verify your equipment's compliance status:

Option 2: Professional MedAire Service

Send your AED to MedAire for comprehensive inspection and service, including:

  • Full compliance verification with manufacturer recall notices
  • Complete device functionality assessment
  • Professional certification of equipment readiness
  • Standard service fees apply

Supply Chain Impact

Stryker is experiencing temporary supply constraints affecting HeartSine Pad-Pak availability due to global component shortages and manufacturing disruptions. While Stryker works to restore full production, no timeline has been established for complete supply restoration.

MedAire Support: Contact MedAire directly for service arrangements and guidance

Manufacturer Support:

  • Stryker Customer Service: +1 800 787 9537 (option 2)
  • Hours: Monday–Friday, 8:00 AM–7:00 PM ET
  • HeartSine Technical Support: heartsinesupport@stryker.com

Manufacturer Support for UK supplied products:

Manufacturer Support for French supplied products:

Regulatory Reporting: Report adverse reactions through the relevant competent authority reporting process.

Important Note: This recall notice applies to PAD-PAK accessories supplied from the UK and French fulfilment centres only.