FDA Medical Device Recalls Up 97% Over Last Decade (Pt. 1)

May 28, 2014

The number of FDA medical device recalls that have been issued since about 2003 has reportedly increased by nearly 97 percent, according to a report recently issued by the FDA’s Center for Devices and Radiological Health (CDRH), Office of Compliance.

The number of FDA medical device recalls issued since about 2003 has reportedly increased by nearly 97 percent, according to a report recently issued by the FDA.

The number of FDA medical device recalls issued since about 2003 has reportedly increased by nearly 97 percent, according to a report recently issued by the FDA.

According to the CDRH report, the most common reasons for issuing these medical device recalls include that the recalled medical devices:

  • Have defective designs
  • Are manufactured with “non-conforming” materials
  • Have serious component issues
  • Have significant software flaws that significantly increase the risk of device malfunctions.

Medical Devices Affected by FDA Recalls

Although a number of differ medical devices have reportedly been the subjects of both Class I and Class II FDA medical device recalls over the past decade or so (with Class I recalls being the most serious recalls issued by the FDA), some of the most highly publicized recalls have pertained to (but are not limited to) the following devices:

  • Metal-on-metal hip implants, such as the DePuy Pinnacle hip implant and the Stryker hip implant
  • Defibrillators and resuscitation systems
  • Heart pumps
  • Anesthesia delivery systems
  • Blood glucose meters
  • Ventilators.

Be sure to check out the upcoming second part of this blog in which we will explore some of the specific reasons as to why there has been such a dramatic increase in the number of FDA medical device recalls issued over the past 10 or so years.

Portland Product Liability Lawyers at the Savage Law Firm

If you or a loved one has been seriously injured due to a dangerous or defective medical device, you can count on the Portland product liability attorneys at the Savage Law Firm to advocate your rights to compensation and justice. For more than three decades, we have been dedicated to providing each of our clients with personal attention, respect and the highest quality legal services.

We realize how devastating permanent injuries caused by dangerous medical devices can be on a physical, as well as a psychological and financial, level, and our lawyers are here to aggressively defend injured people’s rights in any legal setting. While this means that our Portland product liability lawyers will work relentlessly to help our clients tell their stories in court, it also means that our attorneys and dedicated staff will vigorously stand up to insurers and others outside of the courtroom to ensure that our clients are able to obtain the settlements they deserve.

Let’s Talk about Your Case – Portland & Seattle Lawyers

Our Portland product liability attorneys welcome you to learn more about your rights and case by setting up a free initial consult.

To learn more about our legal services and what we can do for you, call us at 503-222-0200 (in Portland) or at 206-957-7272 (in Seattle). You can also email us using the form on this page.

We represent clients in communities in both Oregon and Washington from our offices in Portland and Seattle.

Categories: Blog, Medical Device Recalls, Product Liability