Recall Z-0288-2026— HeartSine Technologies Ltd
Class II · Ongoing
Class II FDA medical device recall by HeartSine Technologies Ltd, initiated 2025-09-18. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact..
- Recalling firm
- HeartSine Technologies Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-18
- Firm location
- Belfast, United Kingdom
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.