Data catalog
FDA device recall notices and early alerts
About 263 records
All records
Every FDA recall notice record published by Orca1, 1000 per page. Each page lists the record id and its name; open a record for key facts, related records and what Orca1 adds.
- Ablation Catheter Correction: Abbott Updates Use Instructions for TactiFlex Ablation…
- Ablation Catheter Correction: Biosense Webster Updates Use Instructions for Varipulse due…
- Alert: Automated Impella Controller Correction due to Cybersecurity Issue from Abiomed
- Alert: Medline Industries, LP Removes Certain Sterile Medline Convenience Kits
- Alert: NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System Due to Rapid…
- Alert: NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System Due to Risk…
- Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set
- Anesthesia Breathing Circuit Correction: Draeger, Inc. Updates Use Instructions for…
- Anesthesia Delivery Systems Recall: GE HealthCare Issues Correction for Certain…
- Anesthesia Kit Correction: Becton Dickinson Issues Correction for BD Spinal Trays…
- Anesthesia Kit Recall: Medline Removes Anesthesia Circuits and Anesthesia Circuit Kits
- Anesthesia Machine Correction: Draeger, Inc. Issues Correction for Atlan A350 and A350XL…
- Anesthesia System Correction: GE HealthCare Updates Use Instructions for CareStation…
- Anesthesia Workstation Correction: Draeger Issues Correction for Atlan A350 and A350 XL
- Anesthetic Vaporizer Recall: Draeger Removes Vapor 2000 and Vapor 3000 Vaporizers
- Angiographic Catheter Recall: Boston Scientific Removes Imager II Angiographic Catheters
- Angiographic Catheter Recall: Cook Removes Beacon Tip Angiographic Catheters due to Tip…
- Angiographic Syringe Recall: Medline Industries Removes Namic Angiographic Rotating…
- Applicator Recall: Integra LifeSciences Removes Extended Tip Applicator Due to Potential…
- Applicator Recall: Integra LifeSciences Removes MicroMyst Applicators Due to Potential…
- Arterial Cannula Recall: Edwards Lifesciences Removes Arterial Cannula due to Risk of Wire…
- Arterial Catheter Recall: Medline Industries, LP, Removes Integrated Arterial Catheters…
- Aspiration Catheter Recall: Q’Apel Medical, Inc. Removes Hippo 072 Aspiration System…
- Aspiration System Correction: Calyxo Updates Use Instructions for CVAC Aspiration Systems
- Automated Compounding System Recall: Omnicell Removes Syringe Labels Used with the…
- Blood and Plasma Warming Device Correction: 3M Company Issues Correction for Ranger…
- Blood Glucose Monitor Recall: Trividia Health Issues Correction for TRUE METRIX Blood…
- Blood Products Administration Set Recall: Fresenius Kabi Removes Large Volume Pump Blood…
- Blood Pump Controller Correction: Abiomed Updates Use Instructions for Automated Impella…
- Breathing Circuit Kit Recall: Sentec/Percussionaire Removes VDR4 Phasitron Breathing…
- Breathing Circuit Recall: Draeger Removes VentStar Resus Neo Hoses
- Breathing Circuit Recall: Medline Removes Neonatal and Infant Heated Wire Breathing…
- Breathing Circuit Set Correction: Hamilton Medical Updates Use Instructions for Breathing…
- Breathing Circuit Set Recall: Hamilton Medical, Inc. Removes Coaxial Breathing Circuit Set…
- Breathing Circuit Set Recall: Hamilton Medical Removes Breathing Circuit Set
- Recall: Draeger Removes SafeStar and TwinStar Filters due to Risk of Misleading Carbon…
- Broselow Pediatric Emergency Rainbow Tape Recall: AirLife Removes Certain Broselow…
- Cardiac Cannula Recall: Medtronic Removes DLP Left Heart Vent Catheter
- Catheter Controller Recall: Abiomed Removes Automated Impella Controllers due to Pump…
- Catheter Controller Recall: Abiomed Removes Automated Impella Controllers due to Purge…
- Catheter Correction: Boston Scientific Updates Use Instructions for POLARx and POLARx FIT…
- Catheter Introducer Correction: Abiomed and Oscor Issue Correction for Catheter Introducer
- Catheter Introducer Kit Recall: Abiomed Removes 14Fr Low Profile Introducer Kits
- Catheter Mount Recall: Draeger Removes ErgoStar Catheter Mounts
- Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and…
- Catheter Recall: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound…
- Closed Suction Catheter Recall: Avanos Medical, Inc. Removes Ballard Closed Suction…
- Continuous Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for G7 Apps and…
- Continuous Glucose Monitoring Software Correction: Dexcom Issues Correction for Dexcom G6…
- Continuous Glucose Monitor Receiver Recall: Dexcom, Inc. Removes Certain Dexcom G6, G7…
- Continuous Ventilator Correction: Baxter Healthcare Corporation Issues Correction for…
- Continuous Ventilator Correction: Philips Respironics Updates Use Instructions for BiPAP…
- Continuous Ventilator (Respirator) Correction: Maquet Critical Care AB Updates Use…
- Convenience Kit Correction: Argon Medical Issues Correction for Convenience Kits…
- Convenience Kit Correction: Arrow International Issues Correction for Convenience Kits…
- Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Huons…
- Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Medline…
- Convenience Kit Correction: Becton Dickinson Issues Correction for Kits and Procedure…
- Convenience Kit Correction: Medical Action Industries Issues Correction for Kits…
- Convenience Kit Correction: Medline Issues Correction for Convenience Kits Containing BD…
- Convenience Kit Correction: Medline Issues Correction for Convenience Kits Containing ICU…
- Convenience Kit Correction: Medline Issues Correction for Kits Containing Huons…
- Convenience Kit Correction: Medline Issues Correction for Kits Containing Huons Lidocaine…
- Convenience Kit Correction: Windstone Medical Packaging, Inc. Issues Correction for…
- Convenience Kit Recall: Integra LifeSciences Removes Tuohy Needle
- Convenience Kit Recall: Aligned Medical Solutions Removes Convenience Kits Containing…
- Convenience Kit Recall: American Contract Systems Removes Convenience Kits Containing…
- Convenience Kit Recall: AVID Medical Removes Convenience Kits Containing Namic RA Syringes
- Convenience Kit Recall: B. Braun Medical, Inc. Removes Spinal Anesthesia Kits Containing…
- Convenience Kit Recall: Medical Action Industries Removes Convenience Kits Containing…
- Convenience Kit Recall: Medline Neonatal and Pediatric Kits Containing Smiths Medical…
- Convenience Kit Recall: Medline Issues Correction for Convenience Kits Containing B. Braun…
- Convenience Kits Recall: Medline Removes Kits that May Contain Recalled Medtronic Cardiac…
- Correction Alert: Becton Dickinson Updates Use Instructions for BD Alaris Pump Issue
- Correction Alert: Medline Industries, LP Updates Use Instructions for Medline Kits…
- Correction Alert: Olympus Updates Use Instructions for Ligating Device
- Cranial Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators Due to…
- Cryoprobe Recall: Erbe USA Removes Flexible Cryoprobes
- Custom Surgical Pack Recall: Alcon Removes Custom Pak Ophthalmic Procedure Packs
- Detachable Coil System Recall: J&J MedTech/CERENOVUS Inc. Remove CEREPAK Detachable Coil…
- Diagnostic Intravascular Catheter Recall: Conavi Removes Novasight Hybrid Catheters
- Dialysis Catheter Kit Recall: Arrow International Removes Dialysis Catheter Kits…
- Dialysis Catheter Recall: Merit Medical Removes 16F Dual-Valved Splittable Sheath…
- Dialysis Tubing Set Correction: Vantive Updates Use Instructions for Prismaflex and Oxiris…
- Disposable Surgical Stapler Correction: Ethicon Endo-Surgery, LLC Issues Correction for…
- Early Alert: Anesthesia Machine Issue from Draeger, Inc.
- Early Alert: Angiographic Catheter Issue from Boston Scientific
- Early Alert: Arrow International Removes Dialysis Catheter Kits Containing Merit Medical…
- Early Alert: Automated Compounding System Issue from Omnicell
- Early Alert: Bloodline Set for Hemodialysis Systems Issue from B. Braun Medical Inc.
- Early Alert: Breathing Circuit Issue from Draeger
- Early Alert: Breathing Circuit Issue from Medline
- Early Alert: Breathing Circuit Set Issue from Hamilton Medical
- Early Alert: Broselow Rainbow Tape Issue from AirLife
- Early Alert: Catheter Introducer Issue from Abiomed and Oscor
- Early Alert: Catheter Introducer Kit Issue from Abiomed
- Early Alert: Convenience Kit Issue from Aligned Medical Solutions
- Early Alert: Convenience Kit Issue from American Contract Systems
- Early Alert: Convenience Kit Issue from AVID Medical
- Early Alert: Convenience Kit Issue from AVID Medical
- Early Alert: Convenience Kit Issue from Becton Dickinson
- Early Alert: Convenience Kit Issue from Medical Action Industries
- Early Alert: Convenience Kit Issue from Medline
- Early Alert: Convenience Kit Issue from Windstone Medical Packaging, Inc.
- Early Alert: Convenience Kit Needle Issue from Integra LifeSciences
- Early Alert: Convenience Kits Issue from Medline
- Early Alert: Diagnostic Ultrasound System Issue from Philips Ultrasound
- Early Alert: Dialysis Tubing Set Issue from Vantive
- Early Alert: Electrophysiology Catheter Issue from Medline ReNewal
- Early Alert: Epidural Kit Issue from Medical Action Industries
- Early Alert: Esophageal pH Monitoring Capsule Delivery Device Issue from Medtronic and…
- Early Alert: Flexible Cryoprobe Issue from Erbe USA
- Early Alert: Handy Solutions Neck & Shoulders Heating Pad Issue from Navajo Manufacturing…
- Early Alert: Heart Pump Controller Issue from Abiomed
- Early Alert: Heart Pump Controller Purge Cassette Issue from Abiomed
- Early Alert: Heart Pump Issue from Abiomed
- Early Alert: Heart Pump Issue from Abiomed
- Early Alert: Heart Pump Purge Cassette Issue from Abiomed
- Early Alert: Infant Resuscitation System Issue from GE HealthCare
- Early Alert: Insufflation Unit Issue from Olympus
- Early Alert: Insulin Pump Issue from Insulet
- Early Alert: Intraosseous Needle Set Issue from Becton Dickinson
- Early Alert: Intravascular Administration Set Issue from Baxter
- Early Alert: IV Start Kit Issue from Avid Medical
- Early Alert: IV Tubing Set Issue from ICU Medical
- Early Alert: Nitric Oxide Delivery System Issue from NOxBOX
- Early Alert: Percutaneous Catheter Issue from Boston Scientific
- Early Alert: Portrait Mobile Monitoring Software Issue from GE HealthCare
- Early Alert: Positive Pressure Breathing Device Issue from Baxter
- Early Alert: Sizing Catheter Issue from Cook Medical
- Early Alert: Stent and Electrocautery-Enhanced Delivery System Issue from Boston…
- Early Alert: Surgical Stapler Issue from Intuitive Surgical
- Early Alert: Thoracic Stent Graft Issue from Bolton Medical
- Early Alert: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring…
- Early Alert: Ventilator Issue from CooperSurgical
- Early Alert: Ventilator Issue from React Health
- Early Alert: Ventilator Issue from Resmed
- Early Alert: Wound and Burn Dressing Issue from Integra LifeSciences
- Electrical Wheelchair Component Correction: mo-Vis BVBA Issues Correction for R-net…
- Electronic Homecare Bed Correction: Medline Updates Use Instructions for Homecare Beds
- Embolization Device Recall and Correction: Medtronic Removes Unused 027 Compatible…
- Emergency Response Safety Kit Recall: Airlife Removes Certain Broselow Pediatric Emergency…
- Endoscope Instrument Recall: Olympus Removes Single Use Guide Sheath Kits Due to Risk for…
- Endoscopic Aspiration Needle Recall: Olympus Removes Certain ViziShot 2 FLEX (19G) Needles…
- Endoscopic Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular…
- Endotracheal Tube Recall: Smiths Medical Removes Intubation ORAL/NASAL Endotracheal Tubes…
- Endovascular Graft Recall: Cook Medical Removes Zenith Alpha 2 Thoracic Endovascular Graft
- Endovascular System Recall: Philips Removes and Discontinues Distribution of Tack…
- Epidural Kit Correction: Medical Action Industries Issues Correction for Epidural Kits…
- Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Bravo CF…
- Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Esophageal pH…
- Esophagogastric Tube Recall: BD Issues Correction for Esophagogastric Balloon Tamponade…
- First Aid Kit Recall: North American Rescue Issues Correction for First Aid Kits…
- Medtronic Removes Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable…
- Gas Powered Emergency Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece…
- Glucose and Glucose/Ketone Meter Correction: Nova Biomedical Corporation Issues Software…
- Glucose Monitor Sensor Recall: Abbott Diabetes Care Removes Certain FreeStyle Libre 3 and…
- Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances…
- Heart Pump Controller Correction: Abiomed Updates Use Instructions for Automated Impella…
- Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers
- Heart Pump Correction: Abiomed Issues Correction for Automated Impella Controllers
- Heart Pump Correction: Abiomed Updates Use Instructions for Impella RP with SmartAssist…
- Heart Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP with SmartAssist…
- Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssist
- Heating Pad Recall: Navajo Manufacturing Company Removes Handy Solutions Neck & Shoulders…
- Hemodialysis Bloodline Set Correction: B. Braun Medical Inc. Issues Correction for…
- Implantable Marker Recall: Hologic Removes BioZorb 3D Bioabsorbable Markers due to Risk…
- Implantable Port Recall: Smiths Medical Removes ProPort Plastic Implantable Ports Due to…
- Infant Breathing System Recall: AirLife/Vyaire Removes Infant Heated Wire Circuits Due to…
- Infant Resuscitation System Correction: GE HealthCare Issues Correction for Giraffe and…
- Infusion Pump Battery Recall: ICU Medical Removes Some CSB Batteries Intended For Use With…
- Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pumps
- Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pump due to…
- Infusion Pump Correction: Fresenius Kabi Issues Correction for dropped or jarred Ivenix…
- Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume…
- Infusion Pump Correction: ICU Medical, Inc. Issues Correction for Plum Duo Infusion System…
- False Alarm Issue with Infusion Pump from Smiths Medical
- Infusion Pump Recall: Fresenius Kabi Removes Ivenix Large Volume Pumps
- Infusion Pump Intermittent Connection Issue from Smiths Medical
- Infusion Pump Thermal Damage Issue from Smiths Medical
- Infusion Pump Recall: Zyno Medical Removes Certain Z-800 Series Infusion Pumps due to…
- Infusion Pumps Correction: Baxter Issues Correction for Novum IQ Infusion Pumps
- Infusion Pump Software Correction: Becton, Dickinson and Company (BD) Issues Correction…
- Infusion Pump Software Correction: Fresenius Kabi Issues Correction for Ivenix Large…
- Infusion Pump Software Recall: Baxter Removes Sigma Spectrum Infusion System Platforms
- Infusion Set Recall: BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion Sets
- Insufflation Unit Recall: Olympus Removes High Flow Insufflation Units
- Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Certain t:slim X2…
- Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Tandem Mobi Insulin…
- Insulin Pump Recall: Insulet Removes Certain Omnipod 5 Pods
- Insulin Pump Recall: Insulet Removes Omnipod Pods
- Intra-Operative Positioning System Guidewire Recall: Centerline Biomedical Removes Certain…
- Intraosseous Needle Set Recall: Becton Dickinson Removes Certain Intraosseous Vascular…
- Intravascular Administration Set Recall: Baxter Removes Duo-Vent Solution Sets
- Intravascular Administration Set Recall: ICU Medical Removes IV Gravity Burette Set
- Intravascular PICC Catheter Recall: Bard Removes PowerPICC Intravascular Catheters
- IV Tubing Set Correction: ICU Medical Updates Use Instructions for IV Tubing Sets
- Liquid Bicarbonate Concentrate Recall: Nipro Removes MedicaLyte Liquid Bicarbonate…
- Manifold Recall: Medline Removes Namic Star Off Handle Manifolds
- Manual Resuscitator Recall: Ambu Inc. Removes SPUR II Resuscitators Due to Blocked…
- Manual Resuscitator Recall: SunMed Holdings, LLC Removes Adult Manual Resuscitator Devices…
- Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline…
- Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline…
- Microbore Extension Set Recall: B. Braun Medical Inc. Removes Microbore Extension Sets
- Mobile Lift Component Recall: Baxter Healthcare Corporation Removes Mobile Lift Component…
- Mobile Power Unit AC Power Cord Recall: Abbott Medical Removes AC Power Cord Associated…
- Monitoring System Correction: GE HealthCare Updates Use Instructions for Portrait Core…
- Alert: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems
- Nitric Oxide Delivery System Correction: NOxBOX Updates Use Instructions for NOxBOXi…
- Organ Recovery Pack Correction: AVID Medical Issues Correction for Medical Convenience and…
- Outpatient Telemetry Correction: Philips Issues Correction for Monitoring Service…
- Oxygen Concentrator Recall: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD Removes JMC5A…
- Pacemaker Correction: Boston Scientific Issues Correction for ACCOLADE Pacemakers and…
- Pacemaker Recall: Boston Scientific Corporation Recalls Accolade Pacemaker Devices Due to…
- Patient Table Correction: Philips Updates Use Instructions for Allura and Azurion Systems…
- Pediatric Care Bed Correction: KayserBetten Issues Correction for KayserBett IDA Beds
- Percutaneous Catheter Recall: Boston Scientific Removes ENROUTE Transcarotid…
- Portable Oxygen Concentrator Car Adapter Recall: Drive DeVilbiss Healthcare Removes iGo…
- Positive Pressure Breathing Device Correction: Baxter Issues Correction for Volera…
- Power Assist Device Recall: Max Mobility/Permobil Removes SpeedControl Dial Component Used…
- Pressure Monitoring Device Recall: Medtronic Neurosurgery Issues Correction for Becker and…
- Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Catheter…
- Purge Cassette Recall: Abiomed Removes Impella Heart Pump Purge Cassettes
- Recall Alert: BALT USA Removes MEGA Ballast Distal Access Platform
- Alert: Baxter Permanently Removes Life2000 Ventilation System
- Recall Alert: Glycar SA Removes Pericardial Patch
- Recall Alert: Intersurgical Inc Removes i-View Video Laryngoscope
- Max Mobility/Permobil Removes All SpeedControl Dials Used with SmartDrive MX2+ Power…
- Reconstruction Prosthesis Correction: Stryker Updates Use Instructions for Patient-Fitted…
- Regard Newborn Kit Recall: ROi CPS, LLC Removes Certain Newborn Kits Due to a Recalled…
- Resuscitation System Recall: ZOLL Circulation, Inc. Recalls AutoPulse NXT Resuscitation…
- Sizing Catheter Recall: Cook Medical Removes Various Centimeter Sizing Catheters
- Sodium Chloride Flush Recall: Spectra Medical Removes Sodium Chloride Injection USP…
- Spinal Cord Stimulator Recall: Boston Scientific Removes Infinion CX Leads
- Stent Recall: Boston Scientific Removes Certain AXIOS Stents and Electrocautery-Enhanced…
- Surgical Stapler Reload Recall: Intuitive Surgical Removes 8mm SureForm 30 Gray Reloads
- System Correction: IMPRIS Imaging Inc Issues Correction for IMRIS Neuro III-SV
- Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System
- Update on Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular
- Update on Alert: Convenience Kit Issue from Medline
- Update on Alert: Defibrillation Lead Issue from Boston Scientific
- Update to Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus
- Update to Alert: Extracorporeal Blood Circuit Issue from Nuwellis
- Update to Alert: Fluid Delivery Set Issue from Medline
- Update on Alert: Infusion Pump Issue from Baxter Healthcare Corporation
- Update to Alert: Infusion Pump Issue from Fresenius Kabi USA
- Update on Alert: Infusion Pump Software Issue from Fresenius Kabi USA
- Update on Early Alert: Infusion Set Performance Issue from BD
- Update to Alert: Nephroscope Sheath Issue from Trokamed GmbH
- Update on Alert: Solution Set Issue from Baxter Healthcare Corporation
- Vaporizer Recall: Getinge Removes Vaporizer Sevoflurane Quick-Fil and Expands Recall of…
- Vascular Access Systems Correction: Boston Scientific Updates Use Instructions for…
- Vascular Cannula Recall: Medtronic Removes Aortic Root Cannula Due to Unexpected Loose…
- Vascular Stent Recall: Boston Scientific Removes Carotid WALLSTENT Monorail Endoprosthesis…
- Ventilator Correction: Baxter Updates Use Instructions for Volara Single-Patient Use…
- Ventilator Correction: Hamilton Medical AG Corrects HAMILTON-C6 Due to Risk of Ventilation…
- Ventilator Correction: Philips Issues Correction for Trilogy Evo Platform Ventilators
- Ventilator Correction: Resmed Issues Correction for Astral Ventilator
- Ventilator Recall: CooperSurgical Removes INCA Infant Nasal CPAP Sets
- Ventilator Recall: Philips Respironics Removes Certain DreamStation Devices Due to…
- Ventilator Recall: React Health Removes VOCSN V+Pro Ventilators
- Ventilator Tubing Correction: Percussionaire Corporation Updates Use Instructions for…
- Wound and Burn Dressing Recall: Integra LifeSciences Removes Certain MediHoney and CVS…
About this dataset
The FDA's Medical Device Recalls and Early Alerts list covers the most serious device recalls, plus early alerts about potentially high-risk device issues while the FDA is still collecting information. A notice is updated as the recall is confirmed or changes.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls and Early Alerts