45 results

• Problems With Recalled Philips Heart Monitoring Application Linked to Injuries, Deaths

  January 14, 2025

  Martha Garcia

  Federal regulators have announced a faulty software program designed to be used with Philips medical devices is at the center of a class I recall, which has led to at least 100 patient injuries and two deaths.

• Problems With Recalled BioZorb Markers Could Cause Severe Injury or Death, FDA Warns

  December 19, 2024

  Irvin Jackson

  The FDA is giving a recent BioZorb marker recall a class I designation, indicating the federal agency believes problems with the device, implanted to assist in targeted therapy in breast cancer patients, can cause serious injuries and potentially death.

• FDA Warns About Failure Risks with Fresenius Ivenix Infusion Pumps

  December 12, 2024

  Martha Garcia

  An alert has been issued about problems with Fresenius Ivenix Infusion pumps, due to a risk that the devices may fail to deliver life-saving drugs to patients.

• Tattoo Ink Bacterial Infection Risks Addressed by FDA

  October 30, 2024

  Darian Hauf

  New federal guidelines have been introduced to help reduce the risk of tattoo ink becoming contaminated by unsanitary equipment or manufacturing environments.

• BioZorb Recall Issued for All Breast Tissue Markers Following Implant Migration, Erosion Problems

  October 25, 2024

  Irvin Jackson

  The FDA is calling for doctors to stop using BioZorb Marker implants, due to serious complications in breast cancer patients, which has led Hologic to remove all remaining devices from the market.

• Ivenix Infusion Pump Recall Issued Due to Risk of Severe Injury or Death

  October 3, 2024

  Darian Hauf

  Customers are being told to stop using the recalled Ivenix Infusion Pumps until new software is installed, to avoid serious risks that may be caused by the devices delivering reduced doses of medications and fluids.

• Ivenix Primary Administration Infusion Pump Recalled Due to Uncontrolled Medication Flow

  September 17, 2024

  Darian Hauf

  Federal health officials have announced a Class I recall of certain Ivenix LVP Primary Administration Sets due to the potential for a manufacturing defect to allow too much medication to be delivered, increasing the risk of an overdose.

• FDA Launches Investigation Into Health Risks from Tampons with Heavy Metals

  September 11, 2024

  Michael Adams

  Following a recent report that found many store bought tampons contain heavy metals, federal regulators have launched an investigation to determine whether women face potential health risks from the toxic chemicals.

• FDA Advises Consumers To Stop Using Antibacterial Soap

  September 5, 2024

  Grace Muller

  Officials indicate that regular soap and water are just fine, since there is a lack of evidence showing that over-the-counter antibacterial soaps are better at preventing illness, and could actually be harmful.

• FDA Issues New Tobacco Age Restriction Enforcement Rules, Targeting Retailers and Vending Machines

  September 4, 2024

  Martha Garcia

  Federal regulators have issued two new rules to help avoid the risk of future smoking-related illnesses among individuals under 21.