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.
Read the official notice →- Date
- 2023-07-19
- Country
- United States
- Brand
- HeartSine Technologies
- Product
- HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access…
- Classification
- Class II
- Units
- Worldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CT, FL, GA, HI,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 → - 2023-03-15
- US
HeartSine Technologies Ltd recalls Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic…
Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.
FDA · DeviceHeartSine Technologies LtdUS: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New…Official notice →
Other drugs & medical recalls in the United States
- 2023-07-26
- US
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC#…
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
- US
Dr Reddy's Laboratories Limited recalls Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409…
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
- 2023-07-19
- US
Beckman Coulter, Inc. recalls COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide and the countries of Argentina, Bolivia…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the country of Panama.Official notice → - US
Stryker Medical Division of Stryker Corporation recalls Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled,…
Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficulty loading/unloading from ambulance, difficulty raising or lowering the cot, cot tip, or erratic or unintended motion.
FDA · DeviceStryker Medical Division of Stryker CorporationWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice →