FDA

71 articles in the TruthFoundry index. Each links out to the original.

• Wedgewood Pharmacy recalls veterinary medications over potency risks · Wedgewood Pharmacy issues national recall of compounded veterinary medications due to lab testing issues.
• Nova Biomedical Recalls StatStrip Glucose Meters Due to Patient ID Error · Nova Biomedical recalls Gen 2.0 StatStrip glucose meters due to software error risking patient misidentification.
• FDA Issues Import Alert for Olympus Medical Devices from Japan · The FDA has issued an import alert for specific Olympus medical devices manufactured in Japan due to quality system violations.
• FDA Issues Early Alert on Cardinal Health Kits with Recalled BD Pumps · FDA warns that Cardinal Health Presource kits may contain recalled BD Alaris pumps risking patient safety.
• FDA Warns of High-Risk Performance Issues in BD Alaris Pump Infusion Sets · FDA issues early alert on BD Alaris Pump Infusion Sets due to potential under-infusion risks for vulnerable patients.
• FDA expands import alert for Olympus medical devices manufactured in Japan · US FDA updated an import alert blocking select Olympus Japan medical devices on 2026-10-20.
• Philips Lumify Ultrasound Class I Recall Issued With Usage Instructions · FDA classifies Philips Lumify ultrasound instruction update as highest severity Class I recall.
• FDA Issues Early Alert on Edwards Lifesciences Mitral Valve Delivery System Issue · FDA warns against using Edwards Lifesciences Commander M delivery systems due to balloon burst risks.
• FDA Classifies BD Alaris Pump Infusion Set Recall as Most Serious Type · BD and CareFusion recall Alaris Pump Infusion Sets due to performance risks causing potential serious injury or death.
• Avid Medical issues Class I recall for contaminated medical convenience kits · Avid Medical recalls IV start kits over fatal fungal contamination risk.
• Par Health Issues Nationwide Recall For Argatroban Injection · Par Health USA recalls 22 Argatroban Injection lots over dangerous particulate contamination.
• Medline orders full destruction of convenience kits in Class I FDA recall · Medline updates recall to require full destruction of affected medical convenience kits.
• Par Health recalls two Brevital Sodium injection lots over particulate matter · Par Health voluntarily recalls two lots of Brevital Sodium 500mg injection due to cellulose particles.
• FDA Issues Early Alert on Philips Lumify Ultrasound Software Glitch · FDA warns Philips Lumify ultrasound systems may fail to recognize transducers without Wi-Fi, causing delays in critical care.
• Nova Biomedical issues global correction for StatStrip glucose meter bug · Nova Biomedical announces global medical device correction for StatStrip Glucose Hospital Meter.
• ICU Medical updates IV tubing instructions after drip chamber investigation · ICU Medical confirms IV drip chamber discoloration poses no patient safety risk
• Draeger VentStar Resus Neo breathing hoses receive FDA Class I recall · FDA classifies Draeger infant breathing hose recall as highest risk Class I status
• Boston Scientific issues Class I recall for Imager II Angiographic Catheters · FDA classifies Boston Scientific Imager II catheter recall as highest severity Class I.
• Becton Dickinson corrects medical kits with recalled saline ampules · FDA classifies BD medical kit correction as highest severity Class I recall.
• Abiomed issues global recall for Automated Impella heart controllers · FDA classifies Abiomed Impella controller recall as highest risk Class I.
• FDA Issues Early Alert on React Health Ventilator Reboot Risk · FDA warns of potential device reboots and therapy interruptions in Ventec Life Systems VOCSN ventilators.
• FDA issues early alert for Abiomed Impella heart pump controller defects · FDA notifies public of high-risk quality issues in Abiomed Impella heart pump controllers.
• FDA Classifies AVID Medical Kit Correction As Class I Recall · AVID Medical corrects medical kits containing recalled Huons sodium chloride ampules.
• CooperSurgical INCA infant CPAP sets receive highest risk FDA recall classification · CooperSurgical recalls infant CPAP sets, classified Class I highest risk by the FDA
• NOxBOX updates NOxBOXi system instructions under FDA Class II recall · NOxBOX issues revised use instructions for NOxBOXi nitric oxide delivery systems per FDA recall.
• Spectra Medical issues highest severity recall for sodium chloride flush ampules · Spectra Medical recalls 0.9% sodium chloride injection ampules over manufacturing sterility risks.
• Medtronic Recalls Esophageal pH Capsule Delivery Devices Due to Injury Risk · Medtronic and Given Imaging recall Bravo CF capsule delivery devices due to potential serious injury or death.
• Medical Action Industries issues Class I recall correction for epidural kits · FDA classifies Medical Action Industries epidural kit correction as highest risk Class I recall.
• BMC Medical recalls Luna G3 APAP devices over firmware shutdown defect · BMC Medical issued an FDA Class I recall for Luna G3 APAP devices with faulty firmware.
• B. Braun Medical recalls sodium chloride injection over particulate matter · B. Braun Medical issues voluntary nationwide recall for 3 lots of 0.9% sodium chloride injection.