50 results

• Tavneos Side Effects Linked to Severe Liver Injuries, FDA Warns

  April 1, 2026

  Michael Adams

  Federal regulators warn Tavneos may cause serious and potentially fatal liver injuries, with postmarketing data identifying 76 adverse cases, including 54 hospitalizations and eight deaths.

• Target, Walmart and Other Retailers Reacted Too Slowly to ByHeart Infant Formula Recall: FDA

  December 16, 2025

  Russell Maas

  The FDA issued warning letters to Walmart, Target, Kroger and Albertsons after investigators found recalled ByHeart infant formula still being sold weeks after retailers were notified the product was linked to a nationwide infant botulism outbreak.

• Boston Scientific Spinal Cord Stimulator Lawsuit Claims Lead and Battery Problems Led to Multiple Revision Surgeries

  October 22, 2025

  Michael Adams

  Boston Scientific and the U.S. Food and Drug Administration (FDA) are facing a lawsuit over an allegedly defective spinal cord stimulator, which claims both the manufacturer and the agency failed to ensure that newer versions of the implant were properly tested for safety and effectiveness.

• Nicotine Pouch Poisoning Among Children Sparks Calls for Safer Packaging

  September 3, 2025

  Michael Adams

  Federal regulators warn that 72% of nicotine pouch exposures involve children under 5 years old, urging safer storage and child-resistant packaging.

• Long-Term Opioid Addiction, Overdose Risks Emphasized on New FDA Label Warnings

  August 7, 2025

  Michael Adams

  New FDA label warnings emphasize the risks of overdose and addiction linked to long-term opioid use, reinforcing ongoing concerns about the lack of safety data for patients with chronic pain.

• Neonatal, Pediatric Intubation Kit Recall Issued by Medline Industries Following Multiple Injuries: FDA

  June 18, 2025

  Darian Hauf

  Federal health officials have announced a Class I recall for certain Medline neonatal and pediatric intubation kits due to undersized endotracheal tubes, which may pose serious health risks.

• Newport Ventilator Recall Issued by Medtronic Following One Patient Death: FDA

  June 16, 2025

  Darian Hauf

  Certain Medtronic Newport ventilators are being recalled and discontinued after federal health officials issued a Class I warning, citing unexpected failures that can stop the machines from delivering proper breathing support.

• Infusion Pump Recalls Affect More Than 300,000 CADD-Solis Portable Devices: FDA

  June 5, 2025

  Darian Hauf

  Federal health officials have announced three recalls for Smiths Medical CADD-Solis infusion pumps due to malfunctions that may interrupt therapy, posing a risk of serious injury or death.

• FDA To Increase Surprise Inspections at Foreign Food and Drug Manufacturing Facilities

  May 15, 2025

  Irvin Jackson

  Federal regulators are looking to address long-standing deficiencies in foreign food and drug inspections, particularly in India and China.

• Medtronic Spinal Cord Stimulator Lawsuit Alleges Device Worsened Pain

  April 30, 2025

  Michael Adams

  Federal regulators accepted hundreds of changes to a Medtronic SCS device without reexamining it for premarket approval, which eventually led a Kentucky woman to experience multiple injuries.