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Alerts and Recalls

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  • CMS Prepares Nation’s Healthcare Facilities for Coronavirus Threat

    Monday, February 10, 2020

    Agency reinforces infection control responsibilities and guidelines for testing to detect coronavirus.

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  • Novel Coronavirus (2019-nCoV)

    Thursday, February 6, 2020

    FDA is working with U.S. Government partners, including the U.S. Centers for Disease Control and Prevention (CDC), and international partners to closely monitor an outbreak caused by a novel (new) coronavirus first identified in Wuhan City, Hubei Province, China.

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  • Cybersecurity Vulnerabilities in Certain GE Healthcare Clinical Information Central Stations and Telemetry Servers

    Monday, January 27, 2020
    The U.S. Food and Drug Administration (FDA) is raising awareness among health care providers and facility staff that cybersecurity vulnerabilities in certain GE Healthcare Clinical Information Central Stations and Telemetry Servers may introduce risks to patients while being monitored.

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  • Update and Interim Guidance on Outbreak of 2019 Novel Coronavirus (2019-nCoV) in Wuhan, China

    Tuesday, January 21, 2020

    The Centers for Disease Control and Prevention (CDC) continues to closely monitor an outbreak of a 2019 novel coronavirus (2019-nCoV) in Wuhan City, Hubei Province, China that began in December 2019. CDC has established an Incident Management System to coordinate a domestic and international public health response.

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  • Stryker Launches Voluntary Field Action for Specific Units of The LIFEPAK® 15 Monitor/Defibrillator

    Tuesday, January 14, 2020
    Stryker announced today that the company is launching a voluntary field action on specific units of the LIFEPAK 15 monitor/defibrillators. The company is notifying a population of LIFEPAK 15 customers of an issue that may cause their devices to fail to deliver a defibrillation shock after the...

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  • Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles

    Tuesday, January 14, 2020
    Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021) in 100 count bottles, NDC 51672-4131-1 to the consumer level. This single lot of Lamotrigine 100 mg...

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  • Elevated Influenza Activity: Influenza B/Victoria and A(H1N1)pdm09 Viruses are the Predominant Viruses

    Monday, January 13, 2020

    This health advisory notifies clinicians that influenza activity remains high in the United States. Ongoing elevated activity is due to influenza B/Victoria viruses, increasing circulation of influenza A(H1N1)pdm09 viruses, and low levels of influenza B/Yamagata and influenza A(H3N2) viruses. CDC’s influenza forecasts suggest that national influenza activity will remain elevated for several more weeks. Because influenza activity is elevated and both influenza A and B virus infections can cause severe disease and death, this health advisory also serves as a reminder that early treatment with antiviral medications improves outcomes in patients with influenza. Early treatment with antiviral medications is recommended for hospitalized patients and high-risk outpatients, including children younger than two years. Clinicians should continue efforts to vaccinate patients for as long as influenza viruses are circulating, and promptly start antiviral treatment of severely ill and high-risk patients with suspected influenza without waiting for laboratory confirmation.

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  • Glenmark Pharmaceuticals Inc., USA Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution

    Thursday, December 19, 2019
    Glenmark Pharmaceutical Inc., USA (“Glenmark”) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300 mg, to the consumer level. The recalled lots of Ranitidine Tablets 150 mg and 300 mg, which are listed in Attachment B, are being recalled...

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  • Medtronic Recalls SynchroMed II Implantable Drug Infusion Pump

    Tuesday, December 17, 2019
    Medtronic received reports of early permanent motor stall due to the potential presence of foreign particles inside the pump motor assembly. Permanent motor stall could prevent the infusion of drugs to the patient, which could cause serious injury, such as drug withdrawal, the return of symptoms of...

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  • B. Braun Medical Inc. Issues Voluntary Nationwide Recall of Twenty-Two Lots of Blood Administration Sets

    Monday, December 2, 2019
    B. Braun Medical Inc. [B. Braun] initiated a voluntary recall of twenty-two (22) lots of Blood Administration Sets. The recalled blood administration sets are used to administer blood from a container to a patient's vascular system through an IV catheter inserted into a vein or central venous...

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