Skip to content
CLIENT PORTAL
  • There are no suggestions because the search field is empty.

Stryker Recall Notice: HeartSine/Samaritan PAD-PAK Accessories (USA Only)

URGENT SAFETY NOTICE - USA MARKET ONLY: 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 FROM MEDSUPPLY PHOENIX EFFECTIVE OCTOBER 6, 2025.

Date: October 6, 2025
Applies to: United States market only
Classification: Urgent Safety Notice

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). This recall applies exclusively to the United States market.

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 has 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 MEDSUPPLY PHOENIX. 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 notifiction 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

Regulatory Reporting: Report adverse reactions through FDA's MedWatch Adverse Event Reporting program

Important Note: This recall notice applies to the United States market only.