{"id":353254,"date":"2016-04-04T10:46:44","date_gmt":"2016-04-04T15:46:44","guid":{"rendered":"https:\/\/content.findlaw-admin.com\/ability-law\/injury\/product-liability\/drugs-and-medical-device-recalls.html"},"modified":"2025-10-17T13:11:00","modified_gmt":"2025-10-17T18:11:00","slug":"drugs-and-medical-device-recalls","status":"publish","type":"page","link":"https:\/\/www.findlaw.com\/injury\/product-liability\/drugs-and-medical-device-recalls.html","title":{"rendered":"Understanding Medical Device Recalls and Your Legal Rights"},"content":{"rendered":"\n
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Understanding Medical Device Recalls and Your Legal Rights<\/h1>\n\n
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\n By Christie Nicholson, J.D.<\/a> | Legally reviewed by Oni Harton, J.D.<\/a>\n | Last updated\n
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This article has been written and reviewed for legal accuracy, clarity, and style by FindLaw\u2019s team of legal writers and attorneys<\/a> and in accordance with our editorial standards<\/a>.<\/em><\/p>\n\n <\/div>\n <\/details>\n\n

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The last updated date refers to the last time this article was reviewed by FindLaw or one of our contributing authors<\/a>. We make every effort to keep our articles updated. For information regarding a specific legal issue affecting you, please contact an attorney in your area<\/a>.<\/em><\/p>\n\n <\/div>\n <\/details>\n<\/section>\n\n\n

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Drug and medical device recalls occur when products are found to be unsafe after reaching the market, often due to defects or health risks. The FDA oversees these recalls to protect public safety and may require manufacturers to remove harmful items.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

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Like any other product, consumers should be able to trust that their medical devices are safe. Manufacturers have a duty of care to ensure their products are safe before they release them to the market. Still, new dangers can appear after manufacturers introduce them to the market.<\/p>\n

One way medical device manufacturers keep future patients safe is to issue recalls when they discover a product may be unsafe. This article addresses medical device recalls, including when and why these recalls occur. You’ll also learn what to do if a defective medical device injures you. At the end of this article, you’ll find a list of legal information for specific medical devices.<\/p>\n

A product liability attorney<\/a> near you can also offer legal advice specific to your situation. If you decide to pursue legal action against a drug or medical device company, you’ll want expert legal help on your side.<\/p>\n

FDA Regulation and Medical Devices<\/h2>\n

The U.S. Food and Drug Administration<\/a> (FDA) reviews and recalls medical devices. It does the same with food, drugs, and cosmetics. When the FDA discovers or learns that a medical device is unsafe, it issues the recall or commands the manufacturer to do the same.<\/p>\n

The FDA’s primary concern is patient safety. If it believes a product is too dangerous to remain on the market, it can demand that the manufacturer take it off the market. These rules apply to American manufacturers and foreign companies exporting medical devices<\/a> to the U.S.<\/p>\n

What Is a Medical Device?<\/h2>\n

A medical device is any tool a doctor or healthcare professional uses to treat a patient. Since there is such a wide variety of medical devices, the FDA divides them into classes<\/a>: Class I, II, and III.\u00a0<\/p>\n

Note: The categorization of medical devices is not the same as the recall\u00a0classification<\/a>.<\/i><\/p>\n

The FDA divides medical devices into different classes based on the potential for harm. Class I devices are less likely to injure patients than Class II devices. A detailed breakdown of the three classes appears in the following sections.<\/p>\n

These classes only apply to the types of devices. For recall categories, the labels are backward. For example, Class I medical devices pose the least risk. But a Class I recall<\/a> is the most serious.<\/p>\n

Medical device manufacturers are strictly liable for any injuries their products cause. If the injured party can prove the device caused their harm, they may recover damages<\/a>.<\/p>\n

If a defective medical device injures you, there’s a chance you may be able to file a product liability lawsuit. Your personal injury attorney<\/a>\u00a0will determine which class your device falls into. This classification will help guide their approach toward proving liability in your case.<\/p>\n

Class I Medical Devices<\/h3>\n

Class I devices are those pivotal to patient care, such as surgical gloves and scalpels. These devices are not likely to cause serious injury. They pose the lowest health consequences and only need general controls.<\/p>\n

Class II Medical Devices<\/h3>\n

Class II devices are those that, when used as directed, may still pose moderate to high risk of health hazards. Class II devices include powered wheelchairs and surgical pumps. This class of medical devices needs general and special controls.<\/p>\n

Class III Medical Devices<\/h3>\n

Class III are devices that support or sustain human life. Manufacturers must use special controls to ensure patient safety. Examples of Class III devices include pacemakers and bone implants.<\/p>\n

Medical Device Recalls<\/h2>\n

The FDA issues a recall<\/a> when it learns that a medical device threatens patient health. Sometimes, the FDA discovers these defects through its investigation. Other times, the medical device manufacturer will contact the FDA on its own. There are also cases where an injured party may communicate a safety defect to the FDA or other government agency.<\/p>\n

Once the FDA recalls a device, it will work with the manufacturer to remove it from the market. If the defect is relatively minor and has mild consequences, the FDA may choose to remove the devices from the market at the wholesale level only. Many consumers never learn of these recalls. But all medical device recalls are available on the FDA’s website<\/a>.<\/p>\n

If the defect is more severe, the FDA may recall the device from retail stores or patients’ homes. This is particularly problematic for patients with recalled devices implanted in their bodies. Many patients with\u00a0artificial hips<\/a>,\u00a0pacemakers<\/a>, or\u00a0transvaginal mesh<\/a>\u00a0need more treatment or surgeries to remove the defective devices.<\/p>\n

When Is a Medical Device Recall Necessary?<\/h2>\n

You may wonder when a medical device recall is necessary. According to the FDA, it will issue a recall in five situations. These situations include the following:<\/p>\n