HeartSine Technologies Ltd: Device Recall

Recall #Z-0288-2026 · 09/18/2025

Class II: Risk

Recall Details

Recall Number
Z-0288-2026
Classification
Class II
Product Type
Device
Recalling Firm
HeartSine Technologies Ltd
Status
Ongoing
Date Initiated
09/18/2025
Location
Belfast, United Kingdom
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,291,165 units

Reason for Recall

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

Product Description

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

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.

Other Recalls by HeartSine Technologies Ltd

View all recalls by HeartSine Technologies Ltd →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.