Recall

FDA Communications Pilot: Calyxo Updates CVAC Aspiration System Instructions – What Manufacturers Need to Know

FDA Communications Pilot: Calyxo Updates CVAC Aspiration System Instructions – What Manufacturers Need to Know

By n8n Publisher |

FDA launches Communications Pilot with Calyxo's CVAC aspiration system instruction update, signaling enhanced recall transparency…

Medical Device Recalls Drop in April 2025: What This Trend Means for Manufacturers

Medical Device Recalls Drop in April 2025: What This Trend Means for Manufacturers

By n8n Publisher |

Medical device recalls declined in April 2025, signaling potential industry improvements in quality management and…

May 2025 FDA Medical Device Recalls: Critical Compliance Lessons for Manufacturers

May 2025 FDA Medical Device Recalls: Critical Compliance Lessons for Manufacturers

By n8n Publisher |

May 2025 FDA device recalls reveal critical compliance gaps. Learn key lessons and actionable strategies…

GAO Report Exposes Critical FDA Staffing Gaps Delaying Medical Device Recalls

GAO Report Exposes Critical FDA Staffing Gaps Delaying Medical Device Recalls

By n8n Publisher |

GAO investigation reveals FDA staffing shortages are delaying critical medical device recall oversight, forcing manufacturers…

Olympus Expands EBUS-TBNA Needle Recall: Critical Component Failure Risks for Medical Device Manufacturers

Olympus Expands EBUS-TBNA Needle Recall: Critical Component Failure Risks for Medical Device Manufacturers

By n8n Publisher |

Olympus expands EBUS-TBNA needle recall due to component ejection risks. Learn compliance implications and actionable…

Abbott’s FreeStyle Libre 3 Correction: Critical Lessons for CGM Manufacturers on Post-Market Surveillance

Abbott’s FreeStyle Libre 3 Correction: Critical Lessons for CGM Manufacturers on Post-Market Surveillance

By n8n Publisher |

Abbott's voluntary FreeStyle Libre 3 correction offers critical lessons for medical device manufacturers on post-market…

Medical Device Recalls Surge to Four-Year High in 2024: Critical Compliance Insights for Manufacturers

Medical Device Recalls Surge to Four-Year High in 2024: Critical Compliance Insights for Manufacturers

By n8n Publisher |

Medical device recalls hit a four-year high in 2024, creating critical compliance challenges. Learn key…

Medtronic Bravo CF Capsule Recall: Critical Lessons for Medical Device Manufacturers on Component Failures

Medtronic Bravo CF Capsule Recall: Critical Lessons for Medical Device Manufacturers on Component Failures

By n8n Publisher |

Medtronic's Bravo CF Capsule recall offers critical lessons for manufacturers on component failures, post-market surveillance,…

Calyxo CVAC Aspiration System Correction: Key Lessons for Medical Device IFU Management

Calyxo CVAC Aspiration System Correction: Key Lessons for Medical Device IFU Management

By n8n Publisher |

FDA announces Calyxo CVAC Aspiration System correction under new Communications Pilot program, highlighting key IFU…

Conavi Novasight Hybrid Catheter Recall: Critical Lessons for Intravascular Device Manufacturers

Conavi Novasight Hybrid Catheter Recall: Critical Lessons for Intravascular Device Manufacturers

By n8n Publisher |

Conavi's Novasight Hybrid Catheter recall highlights critical post-market surveillance gaps. Learn compliance actions for intravascular…

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