Recall Z-0288-2026 ยท MKJ Automated External Defibrillators (Non-Wearable)
HeartSine Technologies Ltd
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
| Date | Oct 23, 2025 (initiated Sep 18, 2025) |
| Status | Open, Classified |
| Reason | Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact. |
| Root cause | Under Investigation by firm |
| Action | 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 thi |
| Quantity | 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, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Ita |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.