Recall

High-Risk Medical Device Recalls of 2024: Legal Consequences and Compliance Lessons

High-Risk Medical Device Recalls of 2024: Legal Consequences and Compliance Lessons

By n8n Publisher |

Major 2024 medical device recalls including BioZorb, Cartiva, and Impella have triggered extensive litigation, revealing…

FDA Issues Class I Recall for Q’Apel Medical Aspiration System: Critical Compliance Lessons for Device Manufacturers

FDA Issues Class I Recall for Q’Apel Medical Aspiration System: Critical Compliance Lessons for Device Manufacturers

By n8n Publisher |

FDA upgrades Q'Apel Medical's aspiration system recall to Class I status, affecting 1,617 units. Learn…

Medtronic Pipeline Vantage 027 Urgent Recall: Critical Compliance Lessons for Medical Device Manufacturers

Medtronic Pipeline Vantage 027 Urgent Recall: Critical Compliance Lessons for Medical Device Manufacturers

By n8n Publisher |

Medtronic's urgent Pipeline Vantage 027 recall offers critical compliance lessons for medical device manufacturers on…

Urgent HeartSine AED Recall at Costco Canada: Critical Compliance Lessons for Medical Device Manufacturers

Urgent HeartSine AED Recall at Costco Canada: Critical Compliance Lessons for Medical Device Manufacturers

By n8n Publisher |

Health Canada's urgent recall of HeartSine AED components sold at Costco highlights critical post-market surveillance…

Understanding Medical Device Recalls: A Complete Guide for Manufacturers

Understanding Medical Device Recalls: A Complete Guide for Manufacturers

By n8n Publisher |

Learn the three classes of medical device recalls, voluntary vs mandated processes, and essential compliance…

Olympus Recalls ViziShot 2 FLEX EBUS-TBNA Needles: Critical Component Detachment Risk

Olympus Recalls ViziShot 2 FLEX EBUS-TBNA Needles: Critical Component Detachment Risk

By n8n Publisher |

Olympus recalls ViziShot 2 FLEX needles due to component detachment risks. Critical compliance lessons for…

FDA Alert Update: Boston Scientific Defibrillation Lead Issue Highlights Critical Recall Communication Changes

FDA Alert Update: Boston Scientific Defibrillation Lead Issue Highlights Critical Recall Communication Changes

By n8n Publisher |

FDA's updated alert on Boston Scientific defibrillation leads showcases new recall communication standards that will…

FDA Updates Fresenius Kabi Infusion Pump Alert: Key Compliance Lessons for Manufacturers

FDA Updates Fresenius Kabi Infusion Pump Alert: Key Compliance Lessons for Manufacturers

By n8n Publisher |

FDA updates Fresenius Kabi infusion pump alert as part of enhanced recall communications pilot, offering…

Essential Medical Device Recall Tracking: 4 Critical Steps for Manufacturers to Enhance Compliance and Patient Safety

Essential Medical Device Recall Tracking: 4 Critical Steps for Manufacturers to Enhance Compliance and Patient Safety

By n8n Publisher |

With 147 medical device recalls in early 2025, including 20 Class I events, manufacturers need…

State of the Nation 2025: Key Insights from the Global Medical Device Recall Index Report

State of the Nation 2025: Key Insights from the Global Medical Device Recall Index Report

By n8n Publisher |

Sedgwick's 2025 Global Medical Device Recall Index Report reveals critical trends and compliance insights that…

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