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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
professionals, patients and consumers.

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MedWatch receives reports from the public and when appropriate, publishes safety
alerts for FDA-regulated products such as:

 * Prescription and over-the-counter medicines
 * Biologics such as blood components, blood/plasma derivatives and gene
   therapies.
 * Medical devices such as hearing aids breast pumps, and pacemakers.
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Other products that the FDA regulates include tobacco products, vaccines, and
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Product Type Biologics Drugs Medical Devices
Year 202220212020201920182017
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DateSafety AlertProduct Type 10/24/2022Baxter Issues Urgent Medical Device
Correction Regarding Potential Radio Frequency Interference With Other Devices
Near Beds Installed With WatchCare SystemMedical Devices, Unapproved
Use10/19/2022 Certain Philips Respironics Masks for BiPAP, CPAP Machines
Recalled Due to Safety Issue with Magnets That May Affect Certain Medical
Devices: FDA Safety CommunicationMedical Devices10/19/20222022 Medical Device
RecallsMedical Devices, Radiation-Emitting Products10/19/2022FAQs on Philips
Respironics Ventilator, BiPAP Machine, and CPAP Machine RecallsMedical
Devices10/19/2022Philips Respironics Recalls Certain Masks for BiPAP, CPAP
Machines Due to Safety Issue with Magnets That May Affect Certain Medical
Devices10/13/2022Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall
of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton
Due to Vial BreakageDefect, Drugs10/12/2022Jiangsu Well Biotech Co., Ltd.
Recalls COVID-19 Ag Rapid Test Devices That Are Not Authorized, Cleared, or
Approved by the FDAMedical Devices09/30/2022LivaNova (TandemLife) Recalls
LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller
Critical FailureMedical Devices09/29/2022Golden State Medical Supply, Inc.
Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel
75 mg Tablets Due to a Label Mix-upDrugs, Mislabeling09/28/2022Proper Trade
LLC/My Stellar Lifestyle Issues Voluntary Nationwide Recall of Wonder Pill
Capsules Due to the Presence of Undeclared TadalafilDrugs, Unapproved Ingredient

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