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gaberuiz13 replied to the topic FDA on Recalled Items in the forum Regulatory Basics for Medical Devices 7 years, 6 months ago
Any medical device of any type can experience a recall for numerous different reasons. One prevailing issue that effects device such as sensor systems is the accuracy and precision of said medical device. Often times the FDA will shut down a company because their product is showing signs of lacking accuracy and precision in measurements. It only takes 24 hours for the FDA to shutdown a project, so its in a company’s best interest to ensure their product lines up with FDA standards out of concern that the project will be taken down. The FDA is a big agency and as such many problems with products that get approved don’t get into the limelight until its unfortunately too late, but this is why companies need to take stride in ensuring their product meets FDA standards. A recall can cost a company a lot more than simply continuing with R&D or even just abandoning the project.
You can view a list of recalled food, drugs, etc. directly on the FDA website with briefs descriptions on why they were recalled: https://www.fda.gov/safety/recalls/