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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:

 * 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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Year 2023202220212020201920182017
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DateSafety AlertProduct Type 09/13/20232023 Medical Device RecallsMedical
Devices09/13/2023Abbott Medical Recalls Proclaim and Infinity IPGs for Inability
to Exit Magnetic Resonance Imaging (MRI) ModeMedical
Devices09/12/2023Mallinckrodt Manufacturing, LLC Recalls One-Way Valve, 22F x
22M for Not Opening ProperlyMedical Devices09/12/2023Bone Matrix Product: FDA
Safety Communication - Important Information for Human Cell, Tissue and Cellular
and Tissue-based Product (HCT/P) Establishments Regarding Tuberculosis
OutbreaksBiologics, Tissue09/11/20232023 Letters to Health Care ProvidersMedical
Devices, Radiation-Emitting Products09/11/2023Novartis Issues Voluntary
Nationwide Recall of One Lot of Sandimmune® Oral Solution (Cyclosporine Oral
Solution, USP), 100 mg/mL Due to CrystallizationDrugs, Impurity09/08/2023Church
& Dwight Issues Voluntary Nationwide Recall of One Specific Lot of TheraBreath
Strawberry Splash for Kids 16oz Sold Exclusively on Amazon Between May 31 and
September 02, 2023, Due to Microbial Contamination Identified as Yeast (Candida
Parapsilosis) Drugs, Microbial Contamination09/08/2023Risk of Protection Failure
with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric
Face Masks: FDA Safety CommunicationMedical Devices09/05/2023Hua Da Trading Inc
dba Wefun Inc Issues Voluntary Nationwide Recall of WEFUN Capsules Due to
Presence of Undeclared SildenafilDietary Supplements, Drugs, Unapproved
Drug09/01/20232023 Safety CommunicationsMedical Devices, Radiation-Emitting
Products

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