HeartSine Technologies Ltd recalls HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines)…
Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
Read the official notice →- Date
- 2026-09-16
- Country
- United States
- Brand
- HeartSine Technologies
- Product
- HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More HeartSine Technologies recalls
- 2026-10-07
USHeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes:…
Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
FDA · DeviceHeartSine Technologies LtdU.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO,…Official notice →- 2025-10-29
- US
HeartSine Technologies Ltd recalls HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
FDA · DeviceHeartSine Technologies LtdUS Nationwide distribution. Worldwide distribution to Argentina, Australia,…Official notice → - 2025-08-06
- US
HeartSine Technologies Ltd recalls HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
FDA · DeviceHeartSine Technologies LtdWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - 2024-05-22
- US
HeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be…
FDA · DeviceHeartSine Technologies LtdUS Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA,…Official notice → - 2024-02-21
- US
HeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM…
Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR duration resulting in the device prompting users to perform CPR for 5-seconds, and…
FDA · DeviceHeartSine Technologies LtdWorldwide - US Nationwide distribution in the states of TX, CA, IL, CO, FL,…Official notice → - 2023-07-19
- US
HeartSine Technologies Ltd recalls HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access…
Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering therapy correctly.
FDA · DeviceHeartSine Technologies LtdWorldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CT, FL, GA, HI,…Official notice →
Other drugs & medical recalls in the United States
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- 2026-09-16
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Windstone Medical Packaging, Inc. recalls AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
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C.R. Bard Inc recalls Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿…
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Atrium Medical Corporation recalls Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4.…
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Lutronic Corporation recalls Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of…
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FDA · DeviceLutronic CorporationWorldwide distribution - US Nationwide and the countries of Canada and…Official notice →