HeartSine Technologies Ltd: Medical Device Recall in 2025 - (Recall #: Z-0288-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: September 18, 2025

Date Posted: October 29, 2025

Recall Number: Z-0288-2026

Event ID: 97651

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1,291,165 units

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated