Skip to main content

Alerts and Recalls

Top
  • CDC Health Advisory: Investigation of Seoul Virus Outbreak Associated with Home-based, Rat breeding Facilities in WI and IL

    Tuesday, January 24, 2017

    CDC and health officials from Wisconsin and Illinois are conducting an investigation of Seoul virus infections among pet rats and persons exposed to rats at rat-breeding facilities in Wisconsin and Illinois. Seoul virus is a member of the hantavirus group of rodent-borne viruses. Trace-back and trace-out investigations of possibly infected rodents have identified distribution chains in other states that may require additional investigations.

    Read More
  • FDA Class 2 Recall: Fresenius 2008 Dialysis Machines due to UF Rate Errors

    Friday, January 20, 2017

    Reason for recall: When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine.

    Read More
  • RECALL: Tego Connector No. D1000, NM1000

    Wednesday, January 18, 2017

    The FDA has announced the recall of the Tego Connector No. D1000, NM1000, a Needle Free Access Device intended for use as an accessory to an HD or infusion catheter.

    Read More
  • Lifepak 1000 Defibrillators by Physio-Control: Remove and Reinstall Battery

    Monday, January 16, 2017

    Physio-Control announced that the company is launching a voluntary field action for the LIFEPAK 1000 defibrillator due to reported instances where the device has shut down unexpectedly during patient treatment.   

    Read More
  • FDA Medical Device Recall: Nurse Assist Normal Saline Flush IV Syringes

    Wednesday, January 4, 2017

    The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

    Read More
  • FDA MedWatch: Pioglitazone-containing Medicines: Drug Safety Communication - Updated FDA Review, Increased Risk of Bladder Cancer

    Monday, December 19, 2016

    As a result of an updated review, the FDA has concluded that use of the type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an increased risk of bladder cancer. The labels of pioglitazone-containing medicines already contain warnings about this risk, and FDA has approved label updates to describe the additional studies reviewed.

    Read More
  • ZIKA UPDATE: CDC Guidance for Travel and Testing of Pregnant Women and Women of Reproductive Age

    Wednesday, December 14, 2016

    On November 28, 2016, the Texas Department of State Health Services (TDSHS) reported the first case of locally acquired mosquito-borne Zika virus infection in the city of Brownsville, Cameron County, Texas. On December 9, 2016, four additional cases in people living in proximity to the first case were reported. TDSHS continues to investigate Zika virus transmission in Brownsville.

    Read More
  • CMS publishes proposed rule on Fire Safety Requirement for Applicable Dialysis Facilities

    Thursday, November 3, 2016

    Today, the Centers for Medicare & Medicaid Services (CMS) announced a proposed rule to update Medicare fire protection guidelines for certain dialysis facilities to ensure that patients are protected from fire while receiving treatment in those facilities. CMS strives to promote health and safety for all patients, family, and staff in every provider and supplier setting, and fire safety requirements are an important part of this effort.

    Read More
  • Skintact DF29N Multi-function Defibrillation Electrodes by Leonhard Lang: Class I Recall - Connector Compatibility Issue

    Tuesday, October 18, 2016

    The Leonhard Lang defibrillation electrode is being recalled due to a connector compatibility issue with the Welch Allyn AED model 10. The user may not be able to connect the electrodes to the defibrillator when a shock is needed. This may result in a delay in delivering the electrical therapy needed to revive a patient in cardiac arrest.

    Read More
  • FDA MedWatch: Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by St. Jude Medical: FDA Safety Communication - Batteries May Fail Earlier Than Expected

    Tuesday, October 11, 2016

    FDA and St. Jude Medical are alerting patients, patient-caregivers, and physicians to respond immediately to Elective Replacement Indicator (ERI) alerts. Due to problems with these batteries, patients do not have the normal 3-month lead time for device replacement. Some batteries have run out within 24 hours of the patient receiving an ERI alert. St. Jude Medical has initiated a recall and correction of the affected devices. See the FDA Safety Communication for a listing of affected devices and data summary.

    Read More