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What Are Early Recall Alerts?

by MDP Staff | Jul 15, 2025 | Alerts, Alerts-Device, FDA_Innovation, Product Recalls, US-FDA

FDA Pilot Program Updates Recall Reporting The goal is to improve early communication Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Recall Communication “Early Alerts” Note: This summary is...

Urgent Recall Alert for BD Alaris Infusion Sets

by MDP Staff | Jul 15, 2025 | Alerts, Alerts-Device, Class I Recalls, FDA Reports

BD Alaris Pump Module model 8100 Performance can worsen when connected to other perfusion sets Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Class I Recall (Correction) The FDA has issued an...

Recall Alert: AirLife/Vyaire Infant Breathing Systems

by Bruce Waldon | Jul 10, 2025 | Alerts-Device, Class I Recalls, Med-Devices, MedWatch-System, Product Recalls, Products_Devices, Safety, US-FDA

AirLife/Vyaire Infant Breathing Systems Recall Potential for risk of disconnection Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Class I Recall AirLife and manufacturer Vyaire are recalling...

Avanos Recalls Ballard Closed Suction Systems

by Bruce Waldon | Jul 10, 2025 | Alerts-Device, Class I Recalls, FDA Safety Communication, Industry News, Med-Devices, MedWatch-System, Product Recalls, US-FDA

Avanos Recalls Ballard Closed Suction Systems Due to sterilization failure Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact May result in non-sterile devices Avanos Medical, Inc. is recalling its...

FDA Alert: Abiomed Impella Blood Pump Controller

by Bruce Waldon | Jul 8, 2025 | Alerts-Device, Class I Recalls, FDA Safety Communication, Med-Devices, MedWatch-System, Product Recalls, Product Safety

FDA Alert: Abiomed Impella Blood Pump Urgent Recall Controller may fail to detect the Impella device Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Abiomed Impella blood pump controllers...

GE HealthCare Anesthesia Systems Recall Due to Ventilation Risk

by Bruce Waldon | Jul 7, 2025 | Alerts-Device, Class I Recalls, FDA Safety Communication, Industry News, Product Recalls, Products_Devices

GE HealthCare Anesthesia Systems Recall potentially life-threatening risk in Volume Control Ventilation (VCV) mode Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact GE Carestation Anesthesia...
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