HeartSine samaritan public access defibrillators may not deliver shocks properly
HeartSine SAM 350P, 360P and 450P public access defibrillators are being recalled because a component manufacturing issue means the device may not function properly to deliver shocks. 190,516 units affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: a defibrillator that may fail to deliver a shock when needed, with no injury reported in the source.
Plain-English summary
The HeartSine samaritan PAD (Public Access Defibrillator), models SAM 350P, SAM 360P and SAM 450P, is being recalled. The action covers 190,516 units, identified by the item numbers, UDI-DI codes and serial numbers in the recall notice.
The stated reason is that, due to a component manufacturing issue, the automated external defibrillator may not function properly to deliver shocks. The FDA classified the action as Class II. The source does not report any injury having occurred.
Distribution was worldwide, including nationwide in the United States across Alaska, Alabama and Arkansas among other states.
Owners should identify affected units using the item numbers, UDI-DI codes and serial numbers in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- Product
- HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
- Manufacturer
- HeartSine Technologies Ltd
- Affected units
- 190,516
Distribution
Related recalls
Same manufacturer · HeartSine Technologies Ltd
See all →- LowHeartSine Defibrillators Recalled for Missing Maintenance Supplement
FDA (Devices) · 2026-10-07
- HighHeartSine SAM Public Access Defibrillators Recalled for Damaged Membrane Tail
FDA (Devices) · 2026-09-16
- HighDefibrillator pad packs recalled over damaged pins disrupting electrical contact
FDA (Devices) · 2025-10-29
- HighHeartSine Public Access Defibrillators Recalled for Voice Prompt Manufacturing Defect
FDA (Devices) · 2024-05-22
- HighHeartSine Samaritan PAD Defibrillators Recalled for Test Configuration Flaw
FDA (Devices) · 2024-02-21
Same hazard · shock delivery failure
See all →- SevereImplantable Defibrillators May Fail to Deliver Therapeutic Shock
FDA (Devices) · 2023-06-28
- SevereCrome Implantable Cardioverter Defibrillators may deliver reduced shock energy
FDA (Devices) · 2022-08-17
- HighDefibtech DDU-2300 AED Recalled for Potential Shock Delivery Failure
FDA (Devices) · 2020-06-24
Similar recalls
- HighHeartSine Public Access Defibrillators Recalled for Voice Prompt Manufacturing Defect
FDA (Devices) · 2024-05-22
- HighHeartSine Samaritan PAD Defibrillators Recalled for Test Configuration Flaw
FDA (Devices) · 2024-02-21
- HighHeartSine SAM Public Access Defibrillators Recalled for Damaged Membrane Tail
FDA (Devices) · 2026-09-16
- LowHeartSine Defibrillators Recalled for Missing Maintenance Supplement
FDA (Devices) · 2026-10-07
- HighHeartSine Defibrillator Battery and Electrode Cartridges May Fail to Function
FDA (Devices) · 2023-07-19
- SevereHeartSine Samaritan 300/300P PAD Devices Recalled for Malfunction
FDA (Devices) · 2012-11-07