RecallReported October 7, 2026
Class III recall by HeartSine Technologies Ltd
HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067…
FDA's enforcement report of October 7, 2026 lists a Class III recall by HeartSine Technologies Ltd of Belfast, United Kingdom. Product: HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067…. Status: Ongoing.
On the record
- Recalling firm
- HeartSine Technologies Ltd
- Location
- Belfast, United Kingdom
- Classification
- Class III
- Status
- Ongoing
- Recall number
- Z-3270-2026
- Product type
- Devices
- Recall initiated
- 2026-07-27
- Reported by FDA
- 2026-10-07
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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