# Class III recall Z-3270-2026: HeartSine Technologies Ltd

**Predicate Speed & CAPA Advisory Opportunity Score:** 46/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3270-2026 |
| Recalling firm | HeartSine Technologies Ltd |
| Classification | Class III |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | HeartSine samaritan PAD (Public Access Defibrillator);   HeartSine SAM 350P   350P US Device, US English - 2 Min CPR   UDI-DI codes: 0506016712067    350P US Device, US English (American Airlines) - 2 Min CPR   UDI-DI code: 0506016712207    350P US Device, US English with Gateway - 2 Min CPR   UDI-DI code: 0506016712804      HeartSine SAM 360P   360P US Device, US English - 2 Min CPR   UDI-DI code: 0506016712068      HeartSine SAM 450P   SAM 450P   US Device, US English (2 min CPR)   UDI-DI code: 0506016712069 |
| Reason | Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check. |
| Quantity | 31,834 |
| Distribution | U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. |
| Recall initiated | 2026-07-27 |
| Reported | 2026-10-07 |
| Firm location | Belfast, United Kingdom |

## Why this score
- Class III recall: lower risk.
- Recall is still ongoing.
- Posted 29 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3270-2026%22). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.