| Early
Alert: Stent and Electrocautery-Enhanced Delivery System Issue from
Boston Scientific 01/16/2026 |
| Anesthetic
Vaporizer Recall: Draeger Removes Vapor 2000 and Vapor 3000 Vaporizers
01/16/2026 |
| Anesthesia
Kit Recall: Medline Removes Anesthesia Circuits and Anesthesia Circuit
Kits 01/16/2026 |
| Early
Alert: Broselow Rainbow Tape Issue from AirLife 01/16/2026 |
| Early
Alert: Dialysis Tubing Set Issue from Vantive 01/14/2026 |
| Organ
Recovery Pack Correction: AVID Medical Issues Correction for Medical
Convenience and Organ Recovery Kits 01/09/2026 |
| Infusion
Pump Software Recall: Baxter Removes Sigma Spectrum Infusion System
Platforms 01/05/2026 |
| Esophageal
pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Bravo
CF Capsule Delivery Devices 01/05/2026 |
| Diagnostic
Intravascular Catheter Recall: Conavi Removes Novasight Hybrid Catheters
01/05/2026 |
| Intravascular
PICC Catheter Recall: Bard Removes PowerPICC Intravascular Catheters
01/05/2026 |
| Aspiration
System Correction: Calyxo Updates Use Instructions for CVAC 01/05/2026 |
| Infusion
Pump Recall: Fresenius Kabi Removes Ivenix Large Volume Pumps
01/05/2026 |
| Custom
Surgical Pack Recall: Alcon Removes Custom Pak Ophthalmic Procedure
Packs 01/02/2026 |
| Intravascular
Administration Set Recall: ICU Medical Removes IV Gravity Burette
Set 12/30/2025 |
Continuous
Glucose Monitoring Software Correction: Dexcom Issues Correction for
Dexcom G6 and G6 Pro
Software 12/29/2025 |
| Anesthesia
System Correction: GE HealthCare Updates Use Instructions for CareStation
Anesthesia Systems 12/29/2025 |
| Catheter
Mount Recall: Draeger Removes ErgoStar Catheter Mounts 12/23/2025 |
| Endovascular
Graft Recall: Cook Medical Removes Zenith Alpha 2 Thoracic Endovascular
Graft 12/23/2025 |
| System
Correction: IMPRIS Imaging Inc Issues Correction for IMRIS Neuro III-SV
12/23/2025 |
| Early
Alert: Convenience Kit Needle Issue from Integra LifeSciences
12/23/2025 |
| Early
Alert: Anesthesia System Issue from GE HealthCare 12/10/2025 |
| Correction
Alert: Olympus Updates Use Instructions for Ligating Device 12/03/2025 |
| Early
Alert: Glucose Monitor Sensor Issue from Abbott Diabetes Care
12/02/2025 |
| Recall
Alert: Glycar SA Removes Pericardial Patch 12/01/2025 |
| Correction
Alert: Becton Dickinson Updates Use Instructions for BD Alaris Pump
Issue 11/28/2025 |
| Recall
Alert: Baxter Permanently Removes Life2000 Ventilation System
11/26/2025 |
| Recall
Alert: BALT USA Removes MEGA Ballast Distal Access Platform 11/26/2025 |
| Recall
Alert: Max Mobility/Permobil Removes All SpeedControl Dials Used with
SmartDrive MX2+ Power Assist Devices 11/25/2025 |
| Early
Alert: Large Volume Pump Primary Administration Set Reverse Flow Issue
from Fresenius Kabi 11/24/2025 |
| Recall
Alert: Intersurgical Inc Removes i-View Video Laryngoscope 11/21/2025 |
| Correction
Alert: Medline Industries, LP Updates Use Instructions for Medline
Kits Containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles
11/21/2025 |
| Alert:
NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System
Due to Rapid Command Input Issue 11/20/2025 |
| Alert:
NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System
Due to Risk for Nitric Oxide Dosing Fluctuations 11/20/2025 |
| Alert:
Medline Industries, LP Removes Certain Sterile Medline Convenience
Kits 11/20/2025 |
| Alert:
Siemens Healthineers Issues Correction for 3 Tesla MRI Systems
11/19/2025 |
| Alert:
Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set
11/19/2025 |
| Alert:
Automated Impella Controller Correction due to Cybersecurity Issue
from Abiomed 10/10/2025 |
| Recall
and Alert Resources 09/29/2025 |
| What
is an Early Alert? 09/29/2025 |
| Blood
and Plasma Warming Device Correction: 3M Company Issues Correction
for Ranger Blood/Fluid Warming System 09/24/2025 |
| Endoscopic
Aspiration Needle Recall: Olympus Removes Certain ViziShot 2 FLEX
(19G) Needles Due to Potentially Deformed A-traumatic Tips 09/24/2025 |
| Early
Alert: TactiFlex Ablation Catheter Issue from Abbott 09/18/2025 |
| Electrical
Wheelchair Component Correction: mo-Vis BVBA Issues Correction for
R-net Joysticks Due to a Firmware Error 09/16/2025 |
| Early
Alert: Medline Kits May Contain Recalled Medtronic Cardiac Cannulas
09/16/2025 |
| Insulin
Pump Correction: Tandem Diabetes Care Issues Correction for Certain
t:slim X2 Insulin Pumps Due to Risk for Faulty Speaker Wiring That
May Cause Malfunction and Stop Insulin Delivery 09/15/2025 |
| Continuous
Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for
G7 Apps and ONE+ Apps due to a Software Design Error That Does Not
Alert Users of Unexpected Sensor Failure 09/12/2025 |
| Ventilator
Recall: Philips Respironics Removes Certain DreamStation Devices Due
to Programming Errors That Can Result in Failed Therapy Modes
09/12/2025 |
| Mobile
Power Unit AC Power Cord Recall: Abbott Medical Removes AC Power Cord
Associated with HeartMate Mobile Power Unit (MPU) Due to Potential
Risk of the Cord Not Locking into Place 08/29/2025 |
| Breathing
Circuit Set Recall: Hamilton Medical, Inc. Removes Coaxial Breathing
Circuit Set Due to Possible Inner Blue Tube Cracks That May Impact
Ventilation 08/29/2025 |
| Manual
Resuscitator Recall: Ambu Inc. Removes SPUR II Resuscitators Due to
Blocked Manometer Port 08/29/2025 |
| Ventilator
Correction: Hamilton Medical AG Corrects HAMILTON-C6 Due to Risk of
Ventilation Interruption from Defective Circuit Board 08/28/2025 |
| Applicator
Recall: Integra LifeSciences Removes Extended Tip Applicator Due to
Potential Sterility and Endotoxin Concerns 08/28/2025 |
| Infusion
Pump Correction: ICU Medical, Inc. Issues Correction for Plum Duo
Infusion System Due to Software Possibly Resulting in Pump Becoming
Unresponsive 08/28/2025 |
| Vascular
Stent Recall: Boston Scientific Removes Carotid WALLSTENT Monorail
Endoprosthesis Due to Risk of Resistance During Device Withdrawal
08/22/2025 |
| Early
Alert: Cardiac Cannula Issue from Medtronic 08/15/2025 |
| Early
Alert: Infusion Pump Issue from Baxter 08/15/2025 |
| Breathing
System Filters Recall: Draeger Removes SafeStar and TwinStar Filters
Due to Risk of Misleading Carbon Dioxide (CO2) Readings
08/12/2025 |
| Early
Alert: WATCHMAN Access System Issue from Boston Scientific 08/06/2025 |
| Early
Alert: Electrophysiology Catheter Issue from Medline ReNewal 08/06/2025 |
| Early
Alert: Defibrillation Lead Issue from Boston Scientific 08/06/2025 |
| Continuous
Ventilator Correction: Philips Respironics Updates Use Instructions
for BiPAP A30, A40, and V30 Devices Due to Interruptions and/or Loss
of Therapy 08/04/2025 |
| Disposable
Surgical Stapler Cartridge Correction: Ethicon Endo-Surgery, LLC Issues
Correction for Endopath Echelon to Address Inadvertent Lockout During
Surgical Procedures 07/25/2025 |
| Arterial
Cannula Recall: Edwards Lifesciences Removes Arterial Cannula due
to Risk of Wire Exposure 07/24/2025 |
| Mobile
Lift Component Recall: Baxter Healthcare Corporation Removes Mobile
Lift Component due to Risk of Improper Attachment 07/23/2025 |
| Early
Alert: Infusion Pump Issue from Baxter 07/22/2025 |
| Medical
Procedure Kits Correction: Medline Industries, LP Issues Correction
for Medline Craniotomy Kits Containing Codman Disposable Perforators
Due to Risk for Device Disassembly 07/22/2025 |
| Continuous
Ventilator (Respirator) Correction: Maquet Critical Care AB Updates
Use Instructions for Servo Ventilator Systems Due to Risk of Inaccurate
Compliance Measurement Leading to Improper Tidal Volume Delivery in
Neonatal Patients 07/21/2025 |
| Applicator
Recall: Integra LifeSciences Removes MicroMyst Applicators Due to
Potential Sterility Concerns 07/21/2025 |
| Manual
Resuscitator Recall: SunMed Holdings, LLC Removes Adult Manual Resuscitator
Devices Due to Incorrect Assembly of B/V Filter 07/18/2025 |
| Continuous
Glucose Monitor Receiver Recall: Dexcom, Inc. Removes Certain Dexcom
G6, G7, ONE, and ONE+ Receivers Due to Speaker Malfunction That May
Cause Missed Alerts for Dangerous Blood Sugar Levels 07/17/2025 |
| Portable
Oxygen Concentrator Car Adapter Recall: Drive DeVilbiss Healthcare
Removes iGo DV6X-619 DC Car Adapter Due to Cord Possibly Becoming
Hot to the Touch and/or Melting While Being Used 07/17/2025 |
| Early
Alert: Microbore Extension Set Issue from B. Braun Medical Inc.
07/17/2025 |
| Cranial
Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators
Due to Risk of Device Disassembly 07/16/2025 |
| Early
Alert: Infusion Set Performance Issue from BD 07/15/2025 |
| Closed
Suction Catheter Recall: Avanos Medical, Inc. Removes Ballard Closed
Suction Systems Due to Risk of Non-Sterility 07/10/2025 |
| Infant
Breathing System Recall: AirLife/Vyaire Removes Infant Heated Wire
Circuits Due to Risk for Inadvertent Adapter Disconnection During
Ventilation 07/09/2025 |
| Broselow
Pediatric Emergency Rainbow Tape Recall: AirLife Removes Certain Broselow
Pediatric Emergency Rainbow Tapes due to Misprinted Information
07/09/2025 |
| Early
Alert: Infusion Pump Software Issue from Baxter 07/01/2025 |
| Early
Alert: Blood Pump Controller Issue from Abiomed 07/01/2025 |
| Angiographic
Catheter Recall: Cook Removes Beacon Tip Angiographic Catheters due
to Tip Separation 06/25/2025 |
| Early
Alert: Esophageal pH Monitoring Capsule Issue from Medtronic 06/24/2025 |
| Resuscitation
System Recall: ZOLL Circulation, Inc. Recalls AutoPulse NXT Resuscitation
System Due to a Failure Code That May Stop Compressions or Deliver
Inadequate CPR 06/23/2025 |
| Medical
Procedure Kits Correction: Medline Industries, LP Issues Correction
for Medline Procedure Kits Containing Medtronic Aortic Root Cannula
due to Potential Excess Material in Male Luers 06/23/2025 |
| Anesthesia
Delivery Systems Recall: GE HealthCare Issues Correction for Certain
Carestations due to Risk of Ineffective Ventilation When Used in Volume
Control Ventilation (VCV) Mode 06/23/2025 |
| Blood
Products Administration Set Recall: Fresenius Kabi Removes Large Volume
Pump Blood Products Administration Sets due to Incorrect Assembly
06/17/2025 |
| Convenience
Kit Recall: Medline Industries, LP, Removes Medline Neonatal and Pediatric
Kits containing Smiths Medical ORAL/NASAL Endotracheal Tubes Due to
Smaller Than Expected Tube Diameter That May Cause Underventilation
06/17/2025 |
| Aspiration
Catheter Recall: Q’Apel Medical, Inc. Removes Hippo 072 Aspiration
System and Cheetah Delivery Tool After FDA Warning Letter About Internal
Processes and Distal Tip Characteristics 06/17/2025 |
| Infusion
Pump Recall: Zyno Medical Removes Certain Z-800 Series Infusion Pumps
due to Software Issue 06/16/2025 |
| Intra-Operative
Positioning System Guidewire Recall: Centerline Biomedical Removes
Certain IOPS Guidewires due to Delamination 06/13/2025 |
| Liquid
Bicarbonate Concentrate Recall: Nipro Removes MedicaLyte Liquid Bicarbonate
Concentrate due to Contamination 06/13/2025 |
|
Flexible
Tracheostomy Tube Recall: Medtronic Removes Shiley Adult Flexible
Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula Due
to Risk for Disconnection of the Flange from the Device Cannula
06/05/2025
|
| Anesthesia
Breathing Circuit Kit Correction: Draeger, Inc. Updates Use Instructions
for VentStar Flex and Anesthesia Circuit Kits Due to Cracks in Hose
That May Cause Inadequate Ventilation 06/05/2025 |
| Infusion
Pump Correction: Baxter Updates Instructions for Use for Novum IQ
Large Volume Pump due to Potential for Underinfusion 06/05/2025 |
| Infusion
Pump Recall: False Alarm Issue with Infusion Pump from Smiths Medical
06/03/2025 |
| Infusion
Pump Recall: Infusion Pump Intermittent Connection Issue from Smiths
Medical 06/03/2025 |
| Infusion
Pump Recall: Infusion Pump Thermal Damage Issue from Smiths Medical
06/03/2025 |
| Esophagogastric
Tube Recall: BD Issues Correction for Esophagogastric Balloon Tamponade
Tubes due to Challenges Removing Plastic Plugs from Rubber Lumen
05/23/2025 |
| Heart
Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit
due to Instances of Sudden Power Loss 04/24/2025 |
| Early
Alert: Intravascular PICC Catheter Issue from BD 04/18/2025 |
| Early
Alert: Diagnostic Intravascular Catheter Issue from Conavi 04/18/2025 |
| Vascular
Cannula Recall: Medtronic Removes Aortic Root Cannula Due to Unexpected
Loose Material in the Male Luer 03/31/2025 |
| Endotracheal
Tube Recall: Smiths Medical Removes Intubation ORAL/NASAL Endotracheal
Tubes Due to Smaller Than Expected Tube Diameter That May Cause Underventilation
03/25/2025 |
| Infusion
Pump Software Correction: Becton, Dickinson and Company (BD) Issues
Correction for BD Alaris Systems Manager and Care Coordination Engine
Infusion Adapter Software Due to Risk for Outdated Automated Programming
Requests to Load 03/20/2025 |
| Early
Alert: Aspiration System Issue from Calyxo 03/20/2025 |
| Implantable
Port Recall: Smiths Medical Removes ProPort Plastic Implantable Ports
Due to Manufacturing Error that May Cause Separation 03/19/2025 |
| Embolization
Device Recall and Correction: Medtronic Removes Unused 027 Compatible
Pipeline Vantage Embolization Device with Shield Technology, Updates
Use Instructions for 021 Compatible Pipeline Vantage Embolization
Devices due to Increased Risk of Incomplete Wall Apposition and Braid
Deformation 03/18/2025 |
| Early
Alert: Infusion Pump Issue from Baxter Healthcare Corporation
03/05/2025 |
| Endovascular
System Recall: Philips Removes and Discontinues Distribution of Tack
Endovascular System Due to User Challenges That Caused Additional
Procedures to Reposition or Remove Implant 03/03/2025 |
| Vaporizer
Recall: Getinge Removes Vaporizer Sevoflurane Quick-Fil and Expands
Recall of Vaporizer Sevoflurane Maquet Filling due to Risk of Patient
and Health Care Professional Exposure to Toxic Chemical Hydrogen Fluoride
03/03/2025 |
| Ablation
Catheter Correction: Biosense Webster Updates Use Instructions for
Varipulse due to High Rate of Stroke or Transient Ischemic Attack
02/28/2025 |
| Patient
Table Correction: Philips Updates Use Instructions for Allura and
Azurion Systems due to Patient Fall Risk from Incorrectly Positioned
Mattresses 02/28/2025 |
| Power
Assist Device Recall: Max Mobility/Permobil Removes SpeedControl Dial
Component Used with SmartDrive MX2+ Power Assist Device Due to Risk
for Motor to Be Unresponsive to the User 02/28/2025 |
| Regard
Newborn Kit Recall: ROi CPS, LLC Removes Certain Newborn Kits Due
to a Recalled Component, the Neo-Tee T-Piece Resuscitator With An
Undersized Controller Spring 02/28/2025 |
| Endoscope
Instrument Recall: Olympus Removes Single Use Guide Sheath Kits Due
to Risk for Radiopaque Guide Sheath Tip Detaching During Procedures
02/28/2025 |
| Pacemaker
Recall: Boston Scientific Corporation Recalls Accolade Pacemaker Devices
Due to a Manufacturing Issue That May Lead to Early Device Replacement
02/21/2025 |
| Heart
Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP
with SmartAssist and Impella RP Flex with SmartAssist Due to A Risk
That the Tip of Guidewires or Other Medical Devices May Come into
Contact with The Impella Pump During Insertion, Adjustment, Or Removal
02/14/2025 |
| Breathing
Circuit Kit Recall: Sentec/Percussionaire Removes VDR4 Phasitron Breathing
Circuits due to Venturi Component Malfunctions that May Reduce Pressure
and Volume Flow 02/10/2025 |
| Arterial
Catheter Recall: Medline Industries, LP, Removes Integrated Arterial
Catheters due to Excess Material at Catheter Hub that May Detach
02/06/2025 |
| Early
Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular
02/06/2025 |
| Oxygen
Concentrator Recall: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
Removes JMC5A Ni/TruAire-5 Oxygen Concentrator due to the devices
spontaneously catching fire 02/05/2025 |
| Continuous
Ventilator Correction: Baxter Healthcare Corporation Issues Correction
for Life2000 Ventilator due to a nonconforming battery charger, which
triggers a battery alarm and renders the ventilator inoperable
02/05/2025 |
| Pressure
Monitoring Device Recall: Medtronic Neurosurgery Issues Correction
for Becker and Exacta External Drainage and Monitoring Systems Due
to Cracks And/Or Leaks in Stopcocks 02/03/2025 |
| Gas
Powered Emergency Resuscitator Recall: Mercury Medical Removes Neo-Tee
T-Piece Resuscitator Due to An Undersized Spring in The Controller
That May Prevent the Device from Delivering the Required Pressure
Levels Needed for Effective Ventilation 01/31/2025 |
| Glucose
and Glucose/Ketone Meter Correction: Nova Biomedical Corporation Issues
Software Correction for StatStrip Glucose and Glucose/Ketone Hospital
Meters Due to Risk for Transmission of Incorrect Patient Results
01/30/2025 |
| Early
Alert: Infusion Pump Software Issue from Fresenius Kabi USA 01/16/2025 |
| Endoscopic
Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular
Update Use Instructions for VasoView HemoPro 2 (VH-4000 and VH-4001)
EVH Systems due to Risk for Bent or Detached Heater Wires and Silicone
Peeling or Detaching During Use 01/15/2025 |
| Outpatient
Telemetry Correction: Philips Issues Correction for Monitoring Service
Application used with Mobile Cardiac Outpatient Telemetry Due to Potential
for Missed Information or Notifications That May Impact Patient Care
01/13/2025 |
