Class I Correction for Abiomed Impella Inaccurate Flow Readings

by Bruce Waldon | Apr 6, 2026 | Alerts, Alerts-Device, Cardiovascular, Implantable Devices, Industry News, Med-Devices, Product Corrections, US-FDA

FDA Class I Recall Abiomed Impella RP heart pumps Home About Consumer News Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact Abiomed Impella RP:...

Class I Correction for Homecare Bed Fire and Entrapment Risks

by Bruce Waldon | Apr 6, 2026 | Alerts, Alerts-Device, Consumer Information, DME, Med-Devices, MedWatch-System, Product Corrections, Safety, US-FDA

FDA Class I Recall Medline homecare beds Home About Consumer News Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact Medline Homecare Beds: FDA...

When a Small Process Failure Becomes a Patient Safety Event

by Bruce Waldon | Mar 23, 2026 | Analysis, Editorial, ISO 14971, Med-Devices, Product Design, Product Quality, Products_Devices, QMSR, Quality system, Reg_Information, Reg_Products, US-FDA

Medical Device Safety Alert Erbe cryoprobes may rupture or burst Home About Consumer Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact What the...

FDA Flags High-Risk Issue with Erbe Flexible Cryoprobes

by Bruce Waldon | Mar 23, 2026 | Alerts, Alerts-Device, Industry Information, Industry News, Med-Devices, MedWatch-System, Product Safety, Safety, US-FDA

Medical Device Safety Alert Erbe cryoprobes may rupture or burst Home About Consumer Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact FDA Flags...

EPA Proposes Rollback of EtO Sterilization Emissions Limits

by Bruce Waldon | Mar 19, 2026 | EtO, Industry Information, Industry News, Med-Devices, Products_Devices, Sterilization, US-FDA

EtO Regulation Rollback EPA seeks to weaken emissions restrictions Home About Consumer Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact EPA...

FDA Approves Novel Device for Pancreatic Cancer Treatment

by Bruce Waldon | Mar 4, 2026 | FDA Approvals, Med-Devices, New devices, Product-Innovation, US-FDA

Medical Device Innovation Optune Pax treats pancreatic cancer with TTFields therapy Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR...