Medical Device Safety Alerts

Consumer-oriented medical device information

Medical Device Safety Alerts

The Food and Drug Administration (FDA) routinely publishes a variety of alerts related to the safety of medical devices.

The agency receives complaints and other safety-related information from health care providers, manufacturers, and consumers on its MedWatch program.

When the FDA deems it to be appropriate based on the severity of the issue, the volume of complaints, or other factors, it will issue a warning or safety alert to health care providers and the public.

Warnings and safety alerts can include product issues, recalls, ancillary safety issues, and any other information related to a negative effect on the safety of a product.

FDA Early Alert for Baxter Intravascular Administration Sets

Healthcare facilities are instructed to immediately stop using affected IV solution sets while FDA evaluates the potentially high-risk device issueThe U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding certain Baxter Duo-Vent Solution Sets...

Class I Recall for Bolton Medical RelayPro Thoracic Stent Graft

FDA Issues Class I Recall for RelayPro Thoracic Stent Graft Following Three Patient DeathsDeployment failure during aortic repair may require emergency open surgery The U.S. Food and Drug Administration (FDA) has issued a Class I recall for certain RelayPro Thoracic...

Arrow Corrects Kits With Recalled Injectable Medications

FDA Classifies Field Correction As Class I Recall Due to Risk of Serious Injury The U.S. Food and Drug Administration (FDA) has classified a correction issued by Arrow International, a subsidiary of Teleflex, as a Class I recall after certain convenience kits were...

FDA Issues Early Alert for Resmed Astral Ventilators

Resmed VentilatorPatients should continue using devices unless instructed otherwise by their healthcare provider The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding a potentially high-risk issue affecting certain Resmed Astral 100 and...

Early Alert: Windstone Medical Recall for Convenience Kits

FDA Warns of Convenience Kits Containing Recalled Cardinal Health Alcohol Pads The FDA has issued an Early Alert regarding several medical convenience kits distributed by Windstone Medical Packaging, Inc. that contain alcohol prep pads previously recalled by Cardinal...

Medical Device FDA Safety Alerts

DateSubjectProduct TypeMore Information
10/15/2026Early Alert: Transcatheter Mitral Valve Delivery System Issue from Edwards LifesciencesTranscatheter Mitral Valve Delivery SystemSafety Communication
10/14/2026Convenience Kit Recall: AVID Medical Removes Convenience Kits Affected by BD ChloraPrep Applicator RecallConvenience KitSafety Communication
10/13/2026Convenience Kit Recall: Medline Removes Convenience Kits Affected by BD ChloraPrep Applicator RecallConvenience KitSafety Communication
10/09/2026Early Alert: Diagnostic Ultrasound System Issue from Philips UltrasoundDiagnostic UltrasoundSafety Communication
10/05/2026IV Tubing Set Correction: ICU Medical Updates Use Instructions for IV Tubing SetsIV Tubing SetSafety Communication
10/05/2026Infusion Set Recall: BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion SetsInfusion SetSafety Communication
10/02/2026Breathing Circuit Recall: Draeger Removes VentStar Resus Neo HosesBreathing CircuitSafety Communication
09/25/2026Angiographic Catheter Recall: Boston Scientific Removes Imager II Angiographic CathetersAngiographic CatheterSafety Communication
09/24/2026Heart Pump Controller Recall: Abiomed Removes Automated Impella ControllersHeart Pump ControllerSafety Communication
09/24/2026Convenience Kit Correction: Becton Dickinson Issues Correction for Kits and Procedure Trays Containing Recalled Sodium Chloride AmpulesConvenience KitSafety Communication
09/23/2026Early Alert: Ventilator Issue from React HealthVentilatorSafety Communication
09/23/2026Early Alert: Heart Pump Controller Issue from AbiomedHeart Pump ControllerSafety Communication
09/21/2026Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Huons Sodium Chloride AmpulesConvenience KitSafety Communication
09/21/2026Ventilator Recall: CooperSurgical Removes INCA Infant Nasal CPAP SetsVentilatorSafety Communication
09/18/2026Sodium Chloride Flush Recall: Spectra Medical Removes Sodium Chloride Injection USP AmpulesSodium Chloride FlushSafety Communication
09/18/2026Nitric Oxide Delivery System Correction: NOxBOX Updates Use Instructions for NOxBOXi Nitric Oxide Delivery SystemNitric Oxide Delivery SystemSafety Communication
09/15/2026Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Esophageal pH Monitoring Capsule Delivery DeviceEsophageal pH Monitoring CapsuleSafety Communication
09/10/2026Epidural Kit Correction: Medical Action Industries Issues Correction for Epidural Kits Containing Spectra Medical Devices Lidocaine AmpulesEpidural KitSafety Communication
09/03/2026Spinal Cord Stimulator Recall: Boston Scientific Removes Infinion CX LeadsSpinal Cord StimulatorSafety Communication
09/03/2026Monitoring System Correction: GE HealthCare Updates Use Instructions for Portrait Core Services SoftwareMonitoring SystemSafety Communication
09/02/2026Convenience Kit Correction: Medline Issues Correction for Convenience Kits Containing BD ChloraPrep ApplicatorsConvenience KitSafety Communication
09/02/2026Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound CathetersElectrophysiology Catheter and Ultrasound CatheterSafety Communication
09/01/2026Breathing Circuit Recall: Medline Removes Neonatal and Infant Heated Wire Breathing CircuitsBreathing CircuitSafety Communication
08/27/2026Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Medline Namic Star Off Handle ManifoldsConvenience KitSafety Communication
08/26/2026Percutaneous Catheter Recall: Boston Scientific Removes ENROUTE Transcarotid Neuroprotection SystemPercutaneous CatheterSafety Communication
08/24/2026Early Alert: Convenience Kit Issue from AVID MedicalConvenience KitSafety Communication
08/20/2026Convenience Kit Recall: Medline Issues Correction for Convenience Kits Containing B. Braun Bupivacaine Hydrochloride ComponentsConvenience KitSafety Communication
08/17/2026Intraosseous Needle Set Recall: Becton Dickinson Removes Certain Intraosseous Vascular Access System Needle SetsIntraosseous Needle SetSafety Communication
08/13/2026Intravascular Administration Set Recall: Baxter Removes Duo-Vent Solution SetsIntravascular Administration SetSafety Communication
08/12/2026Convenience Kit Correction: Medline Issues Correction for Convenience Kits Containing ICU Medical Pain Management ComponentsConvenience KitSafety Communication
08/11/2026Breathing Circuit Set Recall: Hamilton Medical Removes Breathing Circuit SetBreathing CircuitSafety Communication
08/10/2026Catheter Introducer Correction: Abiomed and Oscor Issue Correction for Catheter IntroducerCatheter IntroducerSafety Communication
08/03/2026Convenience Kit Correction: Medline Issues Correction for Kits Containing Huons Lidocaine Hydrochloride and Bupivacaine Hydrochloride in Dextrose InjectionConvenience KitsSafety Communication
08/03/2026Convenience Kit Correction: Medical Action Industries Issues Correction for Kits Containing Recalled Namic ManifoldsConvenience KitsSafety Communication
07/31/2026Ventilator Correction: Resmed Issues Correction for Astral VentilatorVentilatorSafety Communication
07/31/2026Catheter Introducer Kit Recall: Abiomed Removes 14Fr Low Profile Introducer KitsCatheter Introducer KitSafety Communication
07/30/2026Convenience Kit Correction: Argon Medical Issues Correction for Convenience Kits Containing Spectra Medical Device Lidocaine AmpulesConvenience KitsSafety Communication
07/17/2026Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro SystemThoracic Stent GraftSafety Communication
07/16/2026Convenience Kit Correction: Arrow International Issues Correction for Convenience Kits Containing Recalled Huons Lidocaine and Bupivacaine and SalineConvenience KitSafety Communication
07/16/2026Convenience Kit Recall: B. Braun Medical, Inc. Removes Spinal Anesthesia Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USPSpinal Anesthesia KitSafety Communication
07/14/2026Positive Pressure Breathing Device Correction: Baxter Issues Correction for Volera Positive Pressure Breathing DevicesPositive Pressure Breathing DeviceSafety Communication
07/13/2026Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Catheter Delivery Catheter System (DCS)Pulmonary Valve Catheter Delivery SystemSafety Communication
07/07/2026Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Infusion PumpInfusion PumpSafety Communication
07/07/2026Infusion Pump Correction: Fresenius Kabi Issues Correction for dropped or jarred Ivenix Large Volume Infusion PumpsInfusion PumpSafety Communication
07/06/2026Convenience Kit Correction: Windstone Medical Packaging, Inc. Issues Correction for Convenience KitConvenience KitSafety Communication
07/02/2026Insulin Pump Recall: Insulet Removes Omnipod PodsInsulin PumpSafety Communication
07/02/2026Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssistHeart PumpSafety Communication
06/26/2026First Aid Kit Recall: North American Rescue Issues Correction for First Aid Kits Containing TRUE METRIX DevicesFirst Aid KitSafety Communication
06/22/2026Infant Resuscitation System Correction: GE HealthCare Issues Correction for Giraffe and Panda Infant Resuscitation Systems and Warmers with a M1091607-R BlenderInfant Resuscitation SystemSafety Communication
06/22/2026Heart Pump Controller Correction: Abiomed Updates Use Instructions for Automated Impella ControllersHeart Pump ControllerSafety Communication
06/15/2026Anesthesia Machine Correction: Draeger, Inc. Issues Correction for Atlan A350 and A350XL Anesthesia WorkstationsAnesthesia MachineSafety Communication
06/13/2026Convenience Kit Correction: Medline Issues Correction for Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USPConvenience KitSafety Communication
06/11/2026Heart Pump Correction: Abiomed Issues Correction for Automated Impella ControllersHeart PumpSafety Communication
06/03/2026Anesthesia Kit Correction: Becton Dickinson Issues Correction for BD Spinal Trays Containing Bupivacaine AmpulesConvenience KitSafety Communication