HeartSine 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.
Read the official notice →- Date
- 2026-10-07
- Country
- United States
- Brand
- HeartSine Technologies
- Product
- HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes:…
- Classification
- Class III
- Units
- U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-09-16
USHeartSine 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.
FDA · DeviceHeartSine Technologies LtdWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…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
- 2026-10-07
- US
Volcano Corp recalls Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
FDA · DeviceVolcano CorpWorldwide - US Nationwide distribution in the states of MA, MN, TX, AL, GA, CA…Official notice → - US
Bard Peripheral Vascular Inc recalls EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER)…
Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to…
FDA · DeviceBard Peripheral Vascular IncUS Nationwide distribution in the states of KS, SC, CA, TX, GA, NC, PA, SC,…Official notice → - US
Alere San Diego, Inc. recalls Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/…
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FDA · DeviceAlere San Diego, Inc.Worldwide - US Nationwide distribution including in the states of IL, PA, FL,…Official notice → - US
Draeger, Inc. recalls VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
Potential cracks in the hose, which could lead to leakage or the hose falling off.
FDA · DeviceDraeger, Inc.US Nationwide distribution including in the states of IN, AK, AL, AZ, CA, CO,…Official notice → - US
Medline Industries, LP recalls Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITE
Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire.…
FDA · DeviceMedline Industries, LPDistribution US Nationwide including territories of Puerto Rico and Guam and…Official notice → - US
Philips North America Llc recalls Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional…