| Early
Alert: Arrow International Removes Dialysis Catheter Kits Containing
Merit Medical Splittable Sheath Introducers 04/24/2026 |
| Early
Alert: Automated Compounding System Issue from Omnicell 04/24/2026 |
| Early
Alert: Convenience Kit Issue from Aligned Medical Solutions 04/23/2026 |
| Cranial
Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators
Due to Risk of Device Disassembly 04/23/26 |
| Hemodialysis
Bloodline Set Correction: B. Braun Medical Inc. Issues Correction
for Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume
Bloodlines 04/22/26 |
| Insulin
Pump Correction: Tandem Diabetes Care Issues Correction for Tandem
Mobi Insulin Pumps 04/22/2026 |
| Early
Alert: Convenience Kit Issue from American Contract Systems 04/16/2026 |
| Early
Alert: Convenience Kit Issue from Medical Action Industries 04/16/2026 |
| Ventilator
Correction: Philips Issues Correction for Trilogy Evo Platform Ventilators
04/15/2026 |
| Reconstruction
Prosthesis Correction: Stryker Updates Use Instructions for Patient-Fitted
TMJ Implants 04/15/2026 |
| Ventilator
Tubing Correction: Percussionaire Corporation Updates Use Instructions
for Phasitron In-Line Valve 04/15/2026 |
| Anesthesia
Workstation Correction: Draeger Issues Correction for Atlan A350 and
A350 XL 04/14/2026 |
| Dialysis
Catheter Recall: Merit Medical Removes 16F Dual-Valved Splittable
Sheath Introducer 04/14/2026 |
| Early
Alert: Convenience Kit Issue from AVID Medical 04/10/2026 |
| Ventilator
Correction: Baxter Updates Use Instructions for Volara Single-Patient
Use Circuits 04/09/2026 |
| Angiographic
Syringe Recall: Medline Industries Removes Namic Angiographic Rotating
Adaptor Control Syringes 04/09/26 |
| Early
Alert: Sizing Catheter Issue from Cook Medical 04/09/2026 |
| Purge
Cassette Recall: Abiomed Removes Impella Heart Pump Purge Cassettes
Heart Pump Recall Confirmed 04/03/2026 |
| Heart
Pump Correction: Abiomed Updates Use Instructions for Impella RP with
SmartAssist Devices 04/03/2026 |
| Heating
Pad Recall: Navajo Manufacturing Company Removes Handy Solutions Neck
& Shoulders Heating Pad 03/25/2026 |
| Early
Alert: Bloodline Set for Hemodialysis Systems Issue from B. Braun
Medical Inc. 03/25/2026 |
| Cryoprobe
Recall: Erbe USA Removes Flexible Cryoprobes 03/25/2026 |
| Early
Alert: Handy Solutions Neck & Shoulders Heating Pad Issue from
Navajo Manufacturing Company 03/18/2026 |
| Early
Alert: Insulin Pump Issue from Insulet 03/18/2026 |
| Early
Alert: Surgical Stapler Issue from Intuitive Surgical 03/18/2026 |
| Dialysis
Tubing Set Correction: Vantive Updates Use Instructions for Prismaflex
and Oxiris Sets Dialyzer Accessory Recall Confirmed 03/16/2026 |
| Convenience
Kit Recall: Integra LifeSciences Removes Tuohy Needle 03/16/2026 |
| Early
Alert: Flexible Cryoprobe Issue from Erbe USA 03/10/2026 |
| Wound
and Burn Dressing Recall: Integra LifeSciences Removes Certain MediHoney
and CVS Wound and Burn Products 03/06/2026 |
| Catheter
Recall: Medline Industries Removes Reprocessed Electrophysiology and
Ultrasound CathetersEarly 03/05/2026 |
| Catheter
Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology
and Ultrasound Catheters 03/05/2026 |
| Infusion
Pump Software Correction: Fresenius Kabi Issues Correction for Ivenix
Large Volume Pump Software 02/25/2026 |
| Early
Alert: Heart Pump Purge Cassette Issue from Abiomed 02/25/2026 |
| Stent
Recall: Boston Scientific Removes Certain AXIOS Stents and Electrocautery-Enhanced
Delivery Systems Stent Recall Confirmed 02/25/2026 |
| Insufflation
Unit Recall: Olympus Removes High Flow Insufflation Units 02/23/2026 |
| Early
Alert: Trividia Health Issues Correction for TRUE METRIX Blood Glucose
Monitoring Systems 02/17/2026 |
| Electronic
Homecare Bed Correction: Medline Updates Use Instructions for Homecare
Beds 02/13/2026 |
| Emergency
Response Safety Kit Recall: Airlife Removes Certain Broselow Pediatric
Emergency Rainbow Tapes and Broselow ALS Organizers 02/11/2026 |
| Detachable
Coil System Recall: J&J MedTech/CERENOVUS Inc. Remove CEREPAK
Detachable Coil System 02/05/2026 |
| Glucose
Monitor Sensor Recall: Abbott Diabetes Care Removes Certain FreeStyle
Libre 3 and FreeStyle Libre 3 Plus 02/04/2026 |
| Early
Alert: Heart Pump Issue from Abiomed 02/03/2026 |
| Early
Alert: Insufflation Unit Issue from Olympus 01/22/2026 |
| Early
Alert: Wound and Burn Dressing Issue from Integra LifeSciences
01/22/2026 |
| 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 |
