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.
What this means for you
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 →- 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
- HighHeartSine Defibrillator Battery and Electrode Cartridges May Fail to Function
FDA (Devices) · 2023-07-19
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- HighNeuroguard IEP Carotid Stent and Balloon System Recalled for Filter Failure Risk
FDA (Devices) · 2026-08-12
- SevereGEM Premier 5000 PAK Lysing Solution Concentration Recall
FDA (Devices) · 2026-08-12