HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J

FDA device recall Z-0288-2026 · posted 2025-10-23 · Open, Classified

Recall details

Recalling firm

HeartSine Technologies Ltd

Reason for recall

Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.

Action taken

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 RSRecall@stryker.com 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 heartsinesupport@stryker.com.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MKJ

Quantity affected

1,291,165 units

Distribution

US Nationwide distribution. Worldwide distribution to Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Est

Date initiated

2025-09-18

Date posted

2025-10-23

Location

Belfast, United Kingdom