Tag: medical devices
FDA Issues Sterility Correction for Alcohol Prep Pads in Cardinal Health Convenience Kits
The FDA has issued a correction notice for Cardinal Health Webcol Large Alcohol Prep Pads in custom convenience kits manufactured…
MHRA Safety Roundup: June 2026 — Key Drug and Device Alerts for Clinicians
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its June 2026 safety roundup, consolidating critical alerts for…
UK Medical Device Manufacturers Must Navigate New MHRA Registration System Post-Brexit
Medical device manufacturers must now register separately with the UK's MHRA for market access in Great Britain and Northern Ireland…
UK’s MHRA Launches Innovation Guidance to Accelerate Medical Device and Drug Development
The UK's MHRA has published formal guidance for drug and medical device developers, offering free access to regulatory expertise to…
UK Regulators Issue Five Medical Device Safety Alerts in Mid-June 2026
The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued five field safety notices between 15 and 19 June 2026,…
FDA alerts healthcare providers to critical shortage of stereotactic breast biopsy needles
The FDA has formally notified healthcare providers of a supply disruption affecting stereotactic breast biopsy needles (product code KNW), a…
Draeger Anesthesia Workstations Under Correction for Ventilator Failure Risk
Draeger, Inc. has issued a correction for Atlan A350 and A350XL anesthesia workstations due to a manufacturing defect that may…
FDA Issues Early Alert Over Sterility Defect in Alcohol Prep Pads Distributed in Custom Kits
The FDA has issued an early alert regarding a sterility defect in Cardinal Health Webcol Large Alcohol Prep Pads distributed…