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Week of Oct 20, 2025

39

Oct 21, 2025device recall297d agoAccriva Diagnostics, Inc. device recall (Cls III)Co-Diagnostics, Inc.

VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. — Reason: Due to an device without a premarket clearance being incorrectly package and distributed. — Status: Ongoing

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Oct 21, 2025device recall297d agoMedtronic MiniMed, Inc. device recall (Cls II)Medtronic USA Inc

CareLink Clinic, REF: MMT-7350 — Reason: Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia. — Status: Ongoing

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Oct 22, 2025device recall296d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing

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Oct 22, 2025device recall296d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing

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Oct 22, 2025device recall296d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing

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Oct 22, 2025device recall296d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing

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Oct 22, 2025device recall296d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing

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Oct 22, 2025device recall296d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing

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Oct 22, 2025device recall296d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Thunderbeat 5 mm, 10 cm, Inline Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing

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Oct 22, 2025device recall296d agoBioFire Diagnostics, LLC device recall (Cls II)

BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) — Reason: Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures. — Status: Ongoing

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Oct 22, 2025device recall296d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing

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Oct 22, 2025device recall296d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing

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Oct 22, 2025device recall296d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing

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Oct 22, 2025device recall296d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Thunderbeat, 5 mm, 45 cm Inline Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing

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Oct 22, 2025device recall296d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing

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Oct 23, 2025device recall295d agoDatascope Corp. device recall (Cls III)

Cardiosave Rescue — Reason: The IFU addendum updates the Vibration and Shock Table to reference the correct standards. — Status: Ongoing

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Oct 23, 2025device recall295d agoDatascope Corp. device recall (Cls III)

Cardiosave Hybrid — Reason: The IFU addendum updates the Vibration and Shock Table to reference the correct standards. — Status: Ongoing

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Oct 23, 2025device recall295d agoBecton Dickinson & Co. device recall (Cls II)BECTON DICKINSON & CO

BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100; — Reason: The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used. — Status: Ongoing

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Oct 24, 2025device recall294d agoEdan Diagnostics device recall (Cls II)

Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing

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Oct 24, 2025device recall294d agoEdan Diagnostics device recall (Cls II)

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing

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Oct 24, 2025device recall294d agoEdan Diagnostics device recall (Cls II)

Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting. processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records and operate with off-the-shelf software and hardware. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing

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Oct 24, 2025device recall294d agoEdan Diagnostics device recall (Cls II)

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing

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Oct 24, 2025device recall294d agoSiemens Medical Solutions USA, Inc device recall (Cls II)

MAMMOMAT Inspiration; — Reason: There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only. — Status: Ongoing

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Oct 24, 2025device recall294d agoEdan Diagnostics device recall (Cls II)

Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM-CMS via Wi-Fi. The parameters supported are ECG, SpO2 and PR. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing

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Oct 24, 2025device recall294d agoSiemens Medical Solutions USA, Inc device recall (Cls II)

MAMMOMAT Fusion; — Reason: There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only. — Status: Ongoing

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Oct 24, 2025device recall294d agoEdan Diagnostics device recall (Cls II)

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing

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Oct 24, 2025device recall294d agoEdan Diagnostics device recall (Cls II)

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography). Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing

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Oct 24, 2025device recall294d agoEdan Diagnostics device recall (Cls II)

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The patient monitor supports software upgrade online and networking and build-in battery power is available for all the models. iM8 Series Patient Monitor can monitor physiological parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP. The above is the maximum configuration, the user may select different monitoring parameters in according with the requirement. iM8 Series patient monitor includes three models iM8, iM8A, iM8B, and screen size is the primary difference for three models. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing

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Oct 24, 2025device recall294d agoEdan Diagnostics device recall (Cls II)

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing

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Oct 24, 2025device recall294d agoEdan Diagnostics device recall (Cls II)

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospital, hospital type facilities environment and intra-hospital moves. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing

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Oct 24, 2025device recall294d agoGE Medical Systems, LLC device recall (Cls II)

Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography — Reason: Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j). — Status: Ongoing

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Oct 24, 2025device recall294d agoEdan Diagnostics device recall (Cls II)

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults and pediatrics. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing

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Oct 24, 2025device recall294d agoEdan Diagnostics device recall (Cls II)

Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing

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Oct 24, 2025device recall294d agoEdan Diagnostics device recall (Cls II)

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing

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Oct 24, 2025device recall294d agoSiemens Medical Solutions USA, Inc device recall (Cls II)

MAMMOMAT Revelation; — Reason: There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only. — Status: Ongoing

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Oct 24, 2025device recall294d agoEdan Diagnostics device recall (Cls II)

Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing

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Oct 24, 2025device recall294d agoEdan Diagnostics device recall (Cls II)

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing

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Oct 24, 2025device recall294d agoEdan Diagnostics device recall (Cls II)

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), temperature (TEMP), invasive pressure (IBP), Carbon Dioxide (CO2). The system capabilities include storing, displaying, analyzing and controlling such data afterwards. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. The system is intended to be used during patient transport inside and outside of the hospital environment. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing

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Oct 25, 2025device recall293d agoFresenius Medical Care Holdings, Inc. device recall (Cls II)Fresenius Medical Care AG

5008X CAREsystem +CLiC +CDX; — Reason: Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled. — Status: Ongoing

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Week of Oct 27, 2025

11

Oct 27, 2025device recall291d agoMedline Industries, LP device recall (Cls II)

Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS — Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product. — Status: Ongoing

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Oct 27, 2025device recall

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