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FDA News, 2026

 

Recent news from the US Food and Drug Administration. Click title to see the full article at the FDA website. For the most up-to-date headlines, check out the FDA Newsroom. Press announcements from 2004 to 2009 are available through the FDA Archive.

FDA Recalls: FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This site does not contain a complete list of recalls - search for recalls at the official FDA site.

 

2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026

 

June 2026

June 26, 2026 - FDA Proposes Rule That Would Help Hold Foreign Tobacco Product Manufacturers Accountable, Protect Public Health
June 17, 2026 - FDA Approves First Single-Dose Generic Treatment for Influenza
June 16, 2026 - FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose
June 15, 2026 - FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetes
June 12, 2026 - FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children
June 11, 2026 - FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New World Screwworm in Dogs and Cats
June 9, 2026 - FDA Expands Sunscreen Options for the First Time in 20 Years
June 2, 2026 - FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients

 

May 2026

May 29, 2026 - FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs
May 22, 2026 - FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
May 20, 2026 - FDA Warns Retailers Selling Illegal Tobacco Products That Look Like Everyday Products
May 12, 2026 - FDA Finalizes Food Chemical Safety Post-Market Assessment Program, Launches Reassessment of BHT, ADA
May 11, 2026 - FDA Advances Drug Repurposing to Address Unmet Medical Needs

May 8, 2026 - FDA Grants Seventh Approval under the National Priority Voucher Pilot Program

May 8, 2026 - FDA Issues Guidance to Improve Collection of Pregnancy Safety Data for Drugs and Biologics
May 6, 2026 - FDA Expands AI Capabilities and Completes Data Platform Consolidation
May 6, 2026 - FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight
May 5, 2026 - FDA Expands Market Access, Authorizes New ENDS Products
May 1, 2026 - FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug

 

April 2026

April 30, 2026 - FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia
April 30, 2026 - FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List
April 29, 2026 - FDA Releases Results from Largest-Ever Testing of Infant Formula in the U.S.
April 28, 2026 - FDA Announces Major Steps to Implement Real-Time Clinical Trials
April 24, 2026 - FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order
April 23, 2026 - FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program
April 23, 2026 - CMS and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices
April 20, 2026 - FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development
April 16, 2026 - FDA Takes Step Forward on Testosterone Therapy for Men
April 14, 2026 - FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development
April 13, 2026 - FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results
April 1, 2026 - FDA Approves First New Molecular Entity Under National Priority Voucher Program

 

March 2026

March 26, 2026 - FDA Approves First Gene Therapy for Severe Leukocyte Adhesion Deficiency Type I
March 25, 2026 - FDA Approves Drug to Treat Neurologic Manifestations of Hunter Syndrome
March 20, 2026 - FDA Schedules Public Meeting on the Commissioner’s National Priority Voucher Pilot Program
March 19, 2026 - FDA Approves Fourth Product Under National Priority Voucher Program, Higher Dose Semaglutide
March 18, 2026 - FDA Releases Draft Guidance on Alternatives to Animal Testing in Drug Development
March 11, 2026 - FDA Launches New Adverse Event Look-Up Tool
March 10, 2026 - FDA Approves First Treatment for Patients with Cerebral Folate Transport Deficiency
March 9, 2026 - FDA Takes Further Steps to Streamline Biosimilar Development and Make Medicines More Affordable
March 6, 2026 - FDA Holds Meeting with States on Importation of Lower Cost Drugs
March 5, 2026 - FDA Grants Third Approval Under the National Priority Voucher Program
March 5, 2026 - FDA to Address Unused Opioids in American Homes
March 3, 2026 - FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s

 

February 2026

February 26, 2026 - FDA Grants Second Approval under the National Priority Voucher Pilot Program
February 23, 2026 - FDA Launches Framework for Accelerating Development of Individualized Therapies for Ultra-Rare Diseases
February 12, 2026 - FDA Approves First-of-Its-Kind Device to Treat Pancreatic Cancer
February 12, 2026 - FDA Approves Labeling Changes to Menopausal Hormone Therapy Products
February 10, 2026 - FDA Launches Assessment of BHA, a Common Food Chemical Preservative
February 6, 2026 - FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs
February 5, 2026 - FDA Takes New Approach to "No Artificial Colors" Claims
February 1, 2026 - FDA Launches PreCheck Pilot Program to Strengthen Domestic Pharmaceutical Manufacturing

 

January 2026

January 21, 2026 - FDA ImportShield Program Delivers Impressive Results in Strengthening FDA Oversight at U.S. Ports of Entry
January 21, 2026 - FDA Takes Steps to Improve Gluten Ingredient Disclosure in Foods
January 12, 2026 - FDA Approves First Treatment for Children With Menkes Disease
January 12, 2026 - FDA Issues Guidance on Modernizing Statistical Methods for Clinical Trials
January 11, 2026 - FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation

 

Recalls

First Aid Kit Recall: North American Rescue Issues Correction for First Aid Kits Containing TRUE METRIX Devices 06/26/2026
Infant Resuscitation System Correction: GE HealthCare Issues Correction for Giraffe and Panda Infant Resuscitation Systems and Warmers with a M1091607-R Blender 06/22/2026
Heart Pump Controller Correction: Abiomed Updates Use Instructions for Automated Impella Controllers 06/22/2026
Early Alert: Catheter Introducer Issue from Abiomed and Oscor 06/18/2026
Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters 06/18/2026
Early Alert: Convenience Kit Issue from Windstone Medical Packaging, Inc. 06/16/2026
Anesthesia Machine Correction: Draeger, Inc. Issues Correction for Atlan A350 and A350XL Anesthesia Workstations 06/15/2026
Convenience Kit Correction: Medline Issues Correction for Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP 06/13/2026
Convenience Kit Correction: Medline Issues Correction for Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP 06/12/2026
Heart Pump Correction: Abiomed Issues Correction for Automated Impella Controllers 06/11/2026
Early Alert: Positive Pressure Breathing Device Issue from Baxter 06/11/2026
Early Alert: Breathing Circuit Set Issue from Hamilton Medical 06/08/2026
Early Alert: Infant Resuscitation System Issue from GE HealthCare 06/05/2026
Early Alert: Insulin Pump Issue from Insulet 06/04/2026
Anesthesia Kit Correction: Becton Dickinson Issues Correction for BD Spinal Trays Containing Bupivacaine Ampules 06/03/2026
Early Alert: Catheter Introducer Kit Issue from Abiomed 06/02/2026
Pediatric Care Bed Correction: KayserBetten Issues Correction for KayserBett IDA Beds 05/29/2026
Ventilator Correction: Philips Issues Correction for Trilogy Evo Platform Ventilators 05/28/2026
Cryoprobe Recall: Erbe USA Removes Flexible Cryoprobes 05/28/2026
Early Alert: IV Tubing Set Issue from ICU Medical 05/27/2026
Early Alert: Heart Pump Issue from Abiomed 05/27/2026
Manifold Recall: Medline Removes Namic Star Off Handle Manifolds  05/26/2026
Dialysis Catheter Kit Recall: Arrow International Removes Dialysis Catheter Kits Containing Merit Medical Splittable Sheath Introducers 05/26/2026
Early Alert: Heart Pump Controller Issue from Abiomed 05/21/2026
Ventilator Recall: React Health Removes VOCSN V+Pro Ventilators 05/21/2026
Automated Compounding System Recall: Omnicell Removes Syringe Labels Used with the i.v.STATION Automated Compounding System 05/21/2026
Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System 05/20/2026
Early Alert: Anesthesia Machine Issue from Draeger, Inc. 05/15/2026
Convenience Kit Recall: AVID Medical Removes Convenience Kits Containing Namic RA Syringes 05/12/2026
Convenience Kit Recall: Aligned Medical Solutions Removes Convenience Kits Containing Namic RA Syringes 05/11/2026
Pacemaker Correction: Boston Scientific Issues Correction for ACCOLADE Pacemakers and CRT-Ps 05/07/2026
Convenience Kit Recall: Medical Action Industries Removes Convenience Kits Containing Namic RA Syringes Convenience Kit Recall Confirmed 05/07/2026
Convenience Kit Recall: American Contract Systems Removes Convenience Kits Containing Namic RA Syringes Convenience Kit Recall Confirmed 05/07/2026
Surgical Stapler Reload Recall: Intuitive Surgical Removes 8mm SureForm 30 Gray Reloads Surgical Stapler Recall Confirmed 05/05/2026
Sizing Catheter Recall: Cook Medical Removes Various Centimeter Sizing Catheters 05/05/2026
Insulin Pump Recall: Insulet Removes Certain Omnipod 5 Pods 04/29/2026
Blood Glucose Monitor Recall: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems 04/28/2026
Early Alert: Thoracic Stent Graft Issue from Bolton Medical 04/28/2026
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

 

Safety Communications

Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health: FDA Safety Communication 04/28/2026

 

 

Letters to Health Care Providers

Disruptions in Availability of Breast Biopsy Needles - Letter to Health Care Providers 06/16/2026
Disruptions in Availability of Neurosurgical Patties, Sponges, and Strips - Letter to Health Care Providers 05/06/2026

 

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