HeartSine Public Access Defibrillators Recalled for Voice Prompt Manufacturing Defect
Certain HeartSine PAD defibrillators may fail to deliver voice prompts during emergency use due to a manufacturing defect, potentially delaying therapy. Visual instructions remain available.
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: This Class II recall affects critical emergency medical equipment. The manufacturing defect prevents voice prompts during use—a key instructional component—which could cause delayed or absent therapy during cardiac emergencies. No injuries or illnesses have been reported, but the hazard is significant for a high-risk-of-harm medical device.
Plain-English summary
HeartSine Technologies Ltd is recalling HeartSine samaritan PAD defibrillators, models SAM 350P, SAM 360P, and SAM 450P, due to a manufacturing defect affecting voice prompt delivery.
The affected devices may not deliver instructional voice prompts during use. While visual instructional icons remain present, the absence of voice guidance could prevent proper operation during cardiac emergencies and potentially lead to delayed or absent therapy.
Approximately 183,248 units have been distributed nationwide across the United States. Affected device identification numbers and serial number prefixes are available from the FDA to help identify recalled units.
The recalled product
- Product
- HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
- Manufacturer
- HeartSine Technologies Ltd
- Category
- Medical Device — Defibrillator
- Affected units
- 183,248
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 5060167125379
- 5060167120688
- 5060167125720
- 5060167128066
- 5060167122330
- 5060167122491
- M727SAM450P
- 5060167122514
- 5060167121371
- 5060167120671
- 5060167121630
- 5060167128042
- 5060167120701
- 5060167128080
- 5060167120695
- 5060167120725
- 5060167120718
- 5060167120909
- 5060167120916
- 5060167122071
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 samaritan public access defibrillators may not deliver shocks properly
FDA (Devices) · 2025-08-06
- HighHeartSine Samaritan PAD Defibrillators Recalled for Test Configuration Flaw
FDA (Devices) · 2024-02-21
Same hazard · device malfunction
See all →- ModerateBoston Scientific Nalu Therapy Disc Firmware Defect Recall
FDA (Devices) · 2026-11-04
- HighPhilips Azurion 7 M12 Recalled for Unspecified Solid-State Drives
FDA (Devices) · 2026-11-04
- ModeratePhilips Azurion 7 M20 Medical Device Recall for Unspecified SSDs
FDA (Devices) · 2026-11-04
- ModeratePhilips Azurion 3 M15 Medical Device Recall for Unspecified SSDs
FDA (Devices) · 2026-11-04
- ModerateBoston Scientific Recalls Direxion Torqueable Microcatheters Due to Coating Defects
FDA (Devices) · 2026-10-28
Similar recalls
- HighHeartSine samaritan public access defibrillators may not deliver shocks properly
FDA (Devices) · 2025-08-06
- 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
- HighHeartsine Samaritan PAD defibrillators distributed with incorrect language configuration
FDA (Devices) · 2023-03-15
- SevereHeartSine Samaritan 300/300P PAD Devices Recalled for Malfunction
FDA (Devices) · 2012-11-07
- LowHeartSine Defibrillators Recalled for Missing Maintenance Supplement
FDA (Devices) · 2026-10-07