292 results

• Top Medical Device Recalls and Warnings of 2025 Resulting in Lawsuits and Investigations

  December 29, 2025

  Irvin Jackson

  Several major recalls that occurred over the last two years are expected to have a significant impact on medical device and drug litigation throughout 2026.

• LINX Acid Reflux Device Recalled From Foreign Markets

  September 24, 2025

  Irvin Jackson

  All LINX Reflux Management System implants sold around the world may be pulled from the market, except in the U.S., where the manufacturer faces a growing number of product liability lawsuits.

• Insulin Delivery Problems Lead to Tandem t:slim X2 Insulin Pump Recall: FDA

  August 13, 2025

  Michael Adams

  At least 700 adverse events and nearly 60 injuries have been linked to a potential speaker defect in certain Tandem t:slim X2 insulin pumps.

• Ethicon Surgical Stapler Recall Issued After Patient Died When Device Failed Mid-Surgery

  July 28, 2025

  Irvin Jackson

  The FDA has announced a Class I recall for nearly 700,000 Ethicon surgical stapler reloads, warning they can jam mid-procedure and prevent surgeons from finishing critical operations.

• 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.

• Impella Recall Issued Over Guidewire Problems in RP Heart Pump With SmartAssist

  February 17, 2025

  Michael Adams

  An Impella heart pump recall has been issued to update use instructions for all Impella RP heart pumps with SmartAssist due to the risk of injury or death if the device contacts other medical equipment during certain procedures.

• FDA Issues Trokamed Nephroscope Sheath Kidney Rupture Warning After Patient Death

  December 23, 2024

  Martha Garcia

  The FDA is warning healthcare providers about the risks of misusing Trokamed nephroscope sheathes due to potential blockages that could lead to patient injuries and kidney ruptures.

• 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.

• Problems with Giraffe OmniBed Carestation Could Lead to Infant Injuries and Deaths, FDA Warns

  December 10, 2024

  Martha Garcia

  The FDA has designated recent instruction changes for GE Healthcare Giraffe Omnibed Incubators and Carestations as a class I recall, indicating formaldehyde emissions pose a risk of serious injury or death to newborns.

• 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.