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Z-0288-2026 Class II Ongoing

Recalled by HeartSine Technologies Ltd — Belfast

FDA device recall Z-0288-2026 was initiated by HeartSine Technologies Ltd on September 18, 2025 and is designated Class II. Reason for recall: Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact. The recall status is ongoing. Affected quantity: 1,291,165 units.

Recall Details

Product Type: Devices
Report Date: October 29, 2025
Initiation Date: September 18, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,291,165 units

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

Reason for Recall

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

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.

Code Information

PAD-PAK-01, Lot: H017-002-174 and H047-002-100, UDI: 0506016712046; PAD-PAK-02, Lot: H023-002-051, UDI: 0506016712047; PAD-PAK-03, Lot: H017-002-173, H047-002-101, UDI: 0506016712123; PAD-PAK-04, Lot: H023-002-050, UDI: 0506016712124; PAD-PAK-07, Lot: H017-002-178, UDI: 0506016712448; PAD-PAK-03J, Lot: H017-002-071 and H047-002-035, UDI: 0506016712475; PAD-PAK-04J, Lot: H023-002-009, UDI: 0506016712476

Other recalls by HeartSine Technologies Ltd

Z-2174-2025 Class II — HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartS (June 30, 2025)
Z-1820-2024 Class II — HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, (April 8, 2024)
Z-1141-2024 Class II — HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/35 (February 14, 2024)
Z-2143-2023 Class II — HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately (April 26, 2023)
Z-1217-2023 Class II — Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully (February 1, 2023)