Products being recalled depends on many reasons and on what type of product it is. From what I can tell you from previous experience, is that that product may not have been for every single test possible. While I was interning at Prosidyan this summer, they have had to recall some of its lots due to extreme heat issues. Prosidyan makes bone graft substitutes products in the form such as morsels and putty. When these products got realised, there was no issues. But they had a complaint from one customer saying that they product has been melted. When we did some research, we have found that no one has picked up the delivery and had been sitting out in the sun in the packaging. This was never an issue till now because this factor has not been tested. That is why some of the lots of the product have been recalled.

The one reason for a device to be recalled by the FDA is if there are any unforeseen issues that arrive after the product has been approved to be put on the market. In most cases, I believe the companies discover defects or issues themselves and contact the FDA. The only way I could see to improve this process would be more quality control and more controlled trials before gaining approval to eliminate as many issues as possible and test for as many potential problems as possible, though I think it is unlikely to ever completely eliminate all defects even with improved quality assurance as not all unforeseen issues can be caught or predicted beforehand.

The FDA cannot foresee every possible outcome. There are usually a specific set of circumstances under which the device will be used, so if the device can pass certain quality and life-tests, it should not be an issue. However, it is possible for a device to be used outside of the normal mode of usage, or if it was used for a patient it was not originally designed for, resulting in a malfunction. Regardless of whether the patient was or was not instructed to use the device, the complaint must be addressed. If this becomes recurring or causes a fatal error, the device must be recalled even though it passed the previous set of tests. While the manufacturer and the FDA both want to prevent the worst possible outcomes, Murphy's law comes into play. To avoid this as best as possible, the FDA would have to broaden the scope of possible problems and make the criteria for acceptance more narrow.

I agree that once a product is in widespread use, unforeseen problems can sometimes lead to a recall and sometimes, it takes a while for the issue to surface so that it could lead to a recall. Furthermore, sometimes, when the problem can be more complicated relating to the whole system's issue, it may take a long time for a correction to take place.
Here is an interesting case about a controversial product recall: "Transvaginal Mesh". Transvaginal mesh is a product used to support organs and tissue in the pelvic region, such as the uterus or bladder. However, women who received this mesh have suffered from erosion, organ perforation and resulting pain, infection, bleeding, and in some cases permanent damage.There have been a few small recalls, and the U.S. Food and Drug Administration (FDA) has so far not issued recalls, but for the most part, these devices remain on the market. Highly similar surgical meshes have been used by surgeons to repair hernias and other abdominal issues, and so the FDA allowed the use of those meshes for pelvic repairs, including when implanted into the vaginal wall, without first requiring controlled human studies. After a lot of issues/lawsuits came up, The FDA issued one order to reclassify these medical devices from class II to class III. Even though there are at least hundreds of reported complication and many lawsuits, this is an on-going issue and it has been reviewed for years (earlier than 2011). Overall, when it comes to systematic issue and legal loopholes, it may take quite some time to have a public decision/announcement.

Reference: http://www.litigationandtrial.com/vaginal-mesh-implant-erosion-recall/
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm
https://www.recallreport.org/recalls-and-alerts/transvaginal-mesh/

Many companies follow the steps to make sure that there were precautions taken for a product to be used safely, with many tests done. FDA also would not approve such products if they were not safe for people to use at the time. Many of the issues that occur are packaging issues which are not accounted for until the product is completely finished and ready to send out. These issues can also mean there is a labeling error. Sometimes, however, there are device connection errors and software errors that occur which could be accounted for earlier. I believe that they should take a longer time testing the product and making sure there aren’t any technological and software issues that would cause a lot of the recalls. There was an increase in software issues causing an increase in recalls over the years. If FDA and the company made sure there were no malfunctions for any part of the product, there could be less recalls that come with software issues but this would mean using more time to make sure these issues do not happen. They also should not wait so long once the issue is found in the product. It should be reported and done efficiently where it’s not too late to react. Another reason products would need to be recalled is because of a device component change or problem. There are always better options that arise which could mean that a product can have different components to make it function better. I do not believe recalls can be completely avoided but as long as there are proper documentations and there is traceability, it would mean staying ahead of the recall and fixing it as soon as possible.

Recall is used when the manufacturer takes a correction or removal action to address a problem with a medical device that violates the FDA rules. Recalls is done when there is any defect in the medical device which could cause the risk to health. There could be many reasons for the recall like inspecting the device for the problems, repairing the device, adjusting the setting on the device, notifying the patients of the problems and monitoring patients for the health issues. The reason for the recalling late is because the company finds the defects itself. There should more trials and experiments done before it is launched in the market. The recall can be avoided through stronger commitment to product design and quality.

Recalls occur when there is a defect in the medical device. This is usually not a theoretical risk, as that would be more obvious and caught in the development stages. It is usually an unexpected health risks or danger that was reported by users. This includes unexpected side effects, such as early drugs that were shown to cause birth defects. Although the companies did clinical trials, they failed to test or properly assess the results on pregnant woman. Or a medical device that is shown to have a negative effect 20 years down the road, there may be no way to catch that with testing. Another possibility is a medical device that was classified as class II but really needed clinical trials so it is recalled and needs to be reclassified. Some recalls are preventable and some just aren't, and then all action must be done to protect the patients and users.

FDA and manufacturer monitors the products in the market whenever the manufacturer founds any product defective or potential harmful they would recall it or sometime FDA recalled the product after customer complaints. There can be number of reasons like health hazard,poorly packed or labeled. Recall effects the business badly ,it often tarnishes the brand behind the product due to the lack of faith in the products they produce, causing sales to decrease. It can be avoided by using highly specialized skills in quality control, automated manufacturing, validation, and verification. From the initiation phase make sure that the product is defect free. All segments of the supply chain must work tightly together to avoid product recalls Damage occurred during transportation of product also causes recall that means the product should be delivered unspoiled to the end customer. The product should be closely monitored during design and production phase and even after production stage to identify the defect and deal with them. Any changes regarding. design,engineering,manufacturing ,cost, performance should not effect safety of product.

Basically recalling any devices means that a company learnt that it has a device or a product that is violating FDA Laws. So in this case it does two things recalls and gives notification to the FDA. Recalls are also classifies into 3 categories Class 1 that causes severe health hazard, Class 2 causes reversible or temporary hazard, Class 3 does not cause health hazard.

According to me the simplest thing is to label the products with warnings, and instructions. Before launching any product in market we should do proper critical assessment for all kinds of risks.

Recalls usually occur due to the product no longer adhering to the FDA laws. For instances where certain devices are recalled after 5-8 years, I would say it is usually because of long term adverse effects that are not detectable during the preliminary stages of development or even soon after the device is FDA approved. Certain side-effects are only detected after longer periods of time.

I think recalls also happen after a while due to unforeseen complications. A company must always try to maintain QC as is best, perhaps by innovating systems that check the product in a more effective and correct way, but things could go wrong sometimes. If an equipment fails after shown to be effective causing the product to be defective, the company must investigate every single step and maybe is not as simple to find therefore they may choose to recall the product until the situation is resolved. The FDA must oversee the company's strategy and assess in every way the adequacy of the recall as well as having to classify it as class I, II or III

The FDA cannot foresee every possible outcome so, one reason for a device to be recalled by the FDA is if there are any unforeseen issues that arrive after the product released to the market. sometimes, when the problem can be more complicated relating to the whole system’s issue, it may take a long time for a correction to take place. Another reason products would need to be recalled is because of a device component change or problem. I believe the companies discover defects or issues themselves and contact the FDA. Furthermore, I do not think recalls can be completely avoided but as long as there are proper documentations and there is traceability, it would mean staying ahead of the recall and fixing it as soon as possible. Another possibility is a medical device that was classified as class II but really needed clinical trials so it is recalled and needs to be reclassified. The recall can be avoided through stronger commitment to product design and quality.

Sometimes there are circumstances that you could not possibly account for when you are designing a product or reviewing it from the FDA standpoint. While a company may design a product to function a certain way under a certain set of conditions, chances are that someone somewhere using the product will use it in a way that was not thought of or intended, causing a failure or anything else that is cause for concern. From the development standpoint, there are only so many ways you can try to account for anything that could go wrong, and from the FDA standpoint, the same applies. If someone uses a product in a way that is away from the norm, or if the product is undergoing unusual circumstances, then there is a great chance that it will fail or not perform the way it was intended to perform.

This is a great question. I also do not understand why they take so long to make recalls. I know some of my friends whose cars got recalled like years after they bought it. Why would they not have verified it before it was sold to millions of people. There has to be better ways for this to be avoided. Especially in the beginning before they are allowed to be sold. Do these regulations update and maybe that is why they get recalled later on?