Class III recall Z-3270-2026: HeartSine Technologies Ltd
Class III recall Z-3270-2026: HeartSine Technologies Ltd: HeartSine Technologies Ltd. Dated 29 days ago, it is in the active follow-up window. Score 46/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 499 related FDAPulse records and the 5-column CSV export.
| 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 |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-07
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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46 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class III recall: lower risk.
- Recall is still ongoing.
- Posted 29 days ago.
What is the FDAPulse record for Class III recall Z-3270-2026: HeartSine Technologies Ltd?
Class III device recall Z-3270-2026 by HeartSine Technologies Ltd: Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in
How does Class III recall Z-3270-2026: HeartSine Technologies Ltd compare to other FDAPulse records?
It is 29 days old, still within a typical 45-day follow-up window.
Class III recall Z-3270-2026 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class III recall Z-3270-2026 | 2026-10-07 | |
| Class III recall Z-0162-2027 | MA | 2026-10-21 |
| Class III recall Z-0109-2027 | NJ | 2026-10-14 |
| Class III recall Z-0110-2027 | NJ | 2026-10-14 |
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