12 results

• Bivona Trach Tube Recall Lawsuit Claims Device Failure Resulted in Child’s Death

  May 27, 2026

  Michael Adams

  The parents of a 5-year-old girl from England allege that a recalled Bivona pediatric tracheostomy tube failed while she slept, leaving her without oxygen for nearly an hour and causing fatal brain injuries.

• Port-a-Cath Lawsuit Alleges Power P.A.C. Break Down Resulted in Serious Port Catheter Infection

  March 31, 2026

  Irvin Jackson

  ICU Medical faces a port-a-cath lawsuit from a woman who says the device caused her to suffer an infection while undergoing palliative metastatic chemotherapy treatment.

• 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.

• 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.

• Smiths Medical Port Catheter Recall Issued Over Manufacturing Error

  March 20, 2025

  Michael Adams

  The Smiths Medical implantable port catheter’s housing can detach from the reservoir before, during or after implantation, which has resulted in at least two injuries linked to the devices.

• Smiths Medical Trach Tubes May Disconnect From Pilot Balloon, Leading to Severe Injury or Death

  October 28, 2024

  Darian Hauf

  Defects in certain Smiths Medical tracheostomy tube kits may pose ventilation and aspiration problems, which have already led to at least 12 reported injuries.

• ParaPAC Plus Ventilator Recall Issued Due to Risk of Serious Injury or Death

  September 23, 2024

  Darian Hauf

  Smiths Medical has issued an urgent medical device notification for paraPAC plus ventilators, due to a risk that loose or detached outlet connectors may cause serious adverse consequences for patients.

• Bivona Tracheostomy Tube Defects May Cause “Catastrophic” Adverse Events, FDA Warns

  September 9, 2024

  Michael Adams

  Smiths Medical has issued an urgent medical device notification regarding their Bivona tracheostomy tubes not remaining in the proper position, potentially leading to severe injury or death.

• Medfusion Syringe Pump Recall Issued Over Software Errors

  March 6, 2024

  Hannah Brown

  The FDA has announced a Medtronic Syringe Pump recall affecting more than 85,000 units which may over- or under-deliver insulin and important medications due to software errors.

• Medfusion Syringe Pump Recall Issued After Software Error Linked to Injury Risk

  February 15, 2024

  Hannah Brown

  More than 50,000 Medfusion syringe pumps are being recalled due to potential software errors which could interrupt the delivery of life-saving drugs.