FDA MedWatch Alerts/Recall Notices (UNOFFICIAL)

Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication posted 2025-10-15
Additional Details Here.

Alert: Automated Impella Controller Correction due to Cybersecurity Issue from Abiomed posted 2025-10-10
Additional Details Here.

Trividia Health, Inc. Initiates Voluntary Recall of Limited Number of TRUE METRIX® Blood Glucose Meters posted 2025-10-07
Additional Details Here.

Ventilator Recall: Philips Respironics Removes Certain DreamStation Devices Due to Programming Errors That Can Result in Failed Therapy Modes posted 2025-09-12
Additional Details Here.

Electrical Wheelchair Component Correction: mo-Vis BVBA Issues Correction for R-net Joysticks Due to a Firmware Error posted 2025-09-16
Additional Details Here.

Recall and Alert Resources posted 2025-09-29
Additional Details Here.

Blood and Plasma Warming Device Correction: 3M Company Issues Correction for Ranger Blood/Fluid Warming System posted 2025-09-24
Additional Details Here.

Endoscopic Aspiration Needle Recall: Olympus Removes Certain ViziShot 2 FLEX (19G) Needles Due to Potentially Deformed A-traumatic Tips posted 2025-09-24
Additional Details Here.

Early Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed posted 2025-09-23
Additional Details Here.

Olympus Issues Voluntary Recall for Specific Lots of ViziShot 2 FLEX (19G) EBUS -TBNA Needles posted 2025-09-22
Additional Details Here.

FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025 posted 2025-09-17
Additional Details Here.

Early Alert: TactiFlex Ablation Catheter Issue from Abbott posted 2025-09-18
Additional Details Here.

Do Not Use Unauthorized Infant Devices for Monitoring Vital Signs: FDA Safety Communication posted 2025-09-16
Additional Details Here.

Do Not Use Unauthorized Devices for Measuring Blood Pressure: FDA Safety Communication posted 2025-09-16
Additional Details Here.

Electrical Wheelchair Component Correction: mo-Vis BVBA Issues Correction for R-net Joysticks Due to a Firmware Error posted 2025-09-16
Additional Details Here.

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 posted 2025-09-15
Additional Details Here.

BD Provides Update on Voluntary Recall of Certain BD Alaris™ Pump Infusion Sets posted 2025-09-15
Additional Details Here.

Update on Alert: Defibrillation Lead Issue from Boston Scientific posted 2025-09-12
Additional Details Here.

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 posted 2025-09-12
Additional Details Here.

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 posted 2025-08-29
Additional Details Here.

Manual Resuscitator Recall: Ambu Inc. Removes SPUR II Resuscitators Due to Blocked Manometer Port posted 2025-08-29
Additional Details Here.

DermaRite Industries Expands Voluntary Nationwide Recall Due to Potential Burkholderia cepacia Contamination posted 2025-08-28
Additional Details Here.

Applicator Recall: Integra LifeSciences Removes Extended Tip Applicator Due to Potential Sterility and Endotoxin Concerns posted 2025-08-28
Additional Details Here.

Unichem Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, Due to Mislabeling posted 2025-08-27
Additional Details Here.

FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Suspends Biologics License: FDA Safety Communication posted 2025-08-25
Additional Details Here.

Vascular Stent Recall: Boston Scientific Removes Carotid WALLSTENT Monorail Endoprosthesis Due to Risk of Resistance During Device Withdrawal posted 2025-08-22
Additional Details Here.

B. Braun Medical Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL Due to the Presence of Particulate Matter posted 2025-08-19
Additional Details Here.

Early Alert: Infusion Pump Issue from Baxter posted 2025-08-15
Additional Details Here.

Early Alert: Cardiac Cannula Issue from Medtronic posted 2025-08-15
Additional Details Here.

Max Mobility / Permobil Announces Worldwide Expanded Recall and Removal of all SpeedControl Dials from the Market Due to Intermittent Cable Connection Concerns of the Dial with the SmartDrive MX2+ Motor. Users Must Use an Alternate Control ... posted 2025-08-12
Additional Details Here.