Warning Letter to Zoll Medical for Major QMS Violations

by Devices and Pharma | Jun 19, 2026 | Device Warning Letters, Industry Information, Industry News, Med-Devices, Product Quality, Products_Devices, QMSR, Quality system, US-FDA

FDA Warning Letter ZOLL Medical Corporation QSR Violations Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR Central News Enforcement Alerts...

Abiomed Issues Correction for Automated Impella Controllers 

by Devices and Pharma | Jun 16, 2026 | Alerts-Device, Class I Recalls, FDA Safety Communication, Industry Information, Industry News, Med-Devices, MedWatch-System, Products_Devices, Safety, US-FDA

FDA Class I Recall Abiomed Automated Impella Controller Correction Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR Central News...

Infant Formula Recalled after Reports of Botulism

by Devices and Pharma | Jun 16, 2026 | Alerts - Food, Consumer Information, FDA Public Information, FDA Safety Communication, Industry News, MedWatch-System, Products - Food, Recalls, Safety, US-FDA

Product Safety Recall Nara Organics Powdered Infant Formula Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR Central News Enforcement...

FDA Clears First OTC Continuous Glucose Monitor for Children

by Devices and Pharma | Jun 12, 2026 | Consumer Information, FDA Approvals, FDA Public Information, Industry Information, Industry News, Med-Devices, New devices, Products_Devices, US-FDA

Medical Device Innovation First over-the-counter continuous glucose monitor for children Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR...

FDA Early Alert for Baxter Pressure Breathing Device

by Devices and Pharma | Jun 12, 2026 | Alerts-Device, FDA Early Alerts, Med-Devices, Products_Devices, Reg_Products, Safety, US-FDA

FDA Early Alert Baxter Volara System Patient Circuits Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR Central News Enforcement Alerts...