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Medical Device Recalls

FDA Recalls for Medical Devices on the Rise

In the past few years, an increasing number of medical devices have been recalled by the U.S. Food and Drug Administration (FDA) after the FDA determined they present a risk of serious injury or death.

Testing for New Medical Devices

Before most medical devices are put on the market and sold to patients, they must be approved by the FDA. This process is typically a rigorous one and includes years of testing to identify all of the possible weaknesses in a product's design, to determine how a particular product could fail and what can be expected from the device when it is used as intended.

But at times, certain shortcuts are taken to have devices approved. And in some cases, dangers are not apparent in even the most rigorously tested devices until after they have been used for several years.

When complications, injuries and other dangers arise from use of a medical device, the manufacturer or FDA may take the steps to recall the device.

What Does It Mean if a Device or Drug Has Been Recalled?

Typically, when a company receives complaints that one of its products is in violation of the FDA's requirements, it will notify the FDA and may recall the device — especially if it is believed to be defective or pose a risk to the user's health.

But just because a medical device has been recalled does not always mean that it must be removed. Like recalls that often occur for vehicles, sometimes the medical device simply needs to be checked, adjusted or corrected. Removal of some medical devices poses a bigger risk than simply leaving it in place — a doctor will discuss these possible risks with a patient.

In some situations, recalls or safety alerts are issued simply to notify patients of a possible problem or so that the device (or drug) can be relabeled.

How Do I Know if I Have a Recalled Medical Device?

During a medical device recall, the manufacturer or distributor will typically contact those who received the device directly. It will provide information so that you can help identify whether you have a defective product and advise you on steps to take to minimize possible injuries or health problems.

If you think you may have a recalled device, but have not been notified, check out the detailed list of these device recalls found on the FDA's website.

Can I Sue if I Have a Defective Medical Device?

Depending on the specific circumstances of your case, you may be able to pursue a lawsuit. Whatever you do, do not take any money from the medical device manufacturer or sign a waiver until you speak with an experienced medical product liability lawyer. Call 212-750-1200, to speak with an experienced attorney at Trolman, Glaser & Lichtman, P.C., or e-mail our New York office to schedule a free consultation.

Contact Trolman, Glaser, & Lichtman, PC

Trolman, Glaser & Lichtman, P.C.
747 Third Avenue, 23rd Floor | New York, NY 10017
| Phone: 212-750-1200 | Toll Free: 1-888-484-5529 | Fax: 212-980-4011 | Email | New York Law Office

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Contact trolman, glaser & lichtman, PC

747 Third Avenue, 23rd Floor | New York, NY 10017|Phone: 212-750-1200|Toll-Free: 1-888-484-5529|Fax: 212-980-4011|Email