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MEDWATCH: THE FDA SAFETY INFORMATION AND ADVERSE EVENT REPORTING PROGRAM

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MedWatch, the FDA’s medical product safety reporting program for health
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MedWatch receives reports from the public and when appropriate, publishes safety
alerts for FDA-regulated products such as:

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   therapies.
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Product Type Biologics Drugs Medical Devices
Year 20242023202220212020201920182017
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DateSafety AlertProduct Type 09/06/2024Related Recalls - Plastic Syringes Made
in China for Potential Device Failures09/06/2024UPDATE: Evaluating Plastic
Syringes Made in China for Potential Device Failures: FDA Safety
CommunicationMedical Devices09/05/20242024 Medical Device RecallsMedical
Devices, Radiation-Emitting Products09/05/2024Continuous Glucose Monitoring
(CGM) Sensor Recall: Abbott Diabetes Care Inc Issues Recall for Certain
FreeStyle Libre 3 Sensors due to Risk for Inaccurate High Glucose
ReadingsMedical Devices09/05/2024Laryngoscope Recall: Medtronic Removes Certain
McGrath MAC Video Laryngoscopes, Updates Use Instructions for Others due to
Increased Risk for Battery Overheat and Explosion Medical
Devices09/05/2024Ventilator Correction: Breas Medical Updates Use Instructions
for Vivo 45 LS due to Potential Elevated Formaldehyde Levels in Newly
Manufactured VentilatorsMedical Devices09/04/2024Lung Therapy Component Recall:
Baxter Healthcare Corporation Recalls Certain Volara System Single-Patient Use
Circuits and Blue Ventilator Adapter Assemblies Due to Disconnection Risk That
May Prevent Proper VentilationMedical Devices09/04/2024Smiths Medical Issues
Urgent Medical Device Notification Informing Customers of a Potential Issue with
Certain Bivona® Tracheostomy TubesDefect, Medical Devices08/28/2024Tandem
Diabetes Care, Inc. Recalls Version 2.7 of the Apple iOS t:connect Mobile App
Used in Conjunction with t:slim X2 Insulin Pump with Control-IQ Technology
Prompted by a Software Problem Leading to Pump Battery DepletionMedical
Devices08/26/20242023 Safety CommunicationsMedical Devices, Radiation-Emitting
Products

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