FDA Class I Recalls Reach 15-Year Peak in 2022

FDA Class I Recalls

According to an article on medtechdive.com, in 2022, the U.S. Food and Drug Administration (FDA) saw a 15-year high in Class I medical device recalls, as reported by Sedgwick. The FDA managed 70 Class I recalls, the highest risk classification, in 2022, compared to a five-year average of 47. Eighteen of these recalls took place in the final quarter. Mislabeling was the leading cause of recalls in three out of the last five quarters.

Companies such as Abbott, Baxter, GE HealthCare, Medtronic, and Philips faced Class I recalls in the previous year, a category designated by the FDA for issues with the potential to result in severe injury or death. This led to a record-breaking year for Class I recalls.

Sedgwick revealed the 15-year high in Class I recalls after analyzing data from the fourth quarter. During the last three months of the year, the overall number of recalls of any classification rose by 8.1% sequentially, and the number of recalled units increased by approximately 10 million to 61.98 million.

Mislabeling was the primary cause of recalls in the fourth quarter, consistent with three of the past five quarters, followed by quality. The number of recalls related to software, the leading cause of recalls in the third quarter, decreased. Software accounted for 15 recalls in the final quarter, compared to 46 events in the previous period.

Based on January’s data, the increase in recalls between the third and fourth quarters may persist into 2023, according to the report. Sedgwick recorded 135 recalls in January, compared to a monthly average of 80 in the fourth quarter. The number of recalled units is also trending higher than the rate observed in the fourth quarter.

Sedgwick highlighted the FDA’s use of Section 518 authority, which permits the agency to require manufacturers to inform patients and providers of risks, as a significant development in medical device recalls. The FDA utilized this power a year ago to mandate Philips to inform patients about its respiratory device recall, as the company’s efforts up to that point had been deemed “inadequate” by the agency.

What To do if you are injured or lost a loved one due to a defective product?

If you or a loved one has been injured or suffered a loss due to a defective product, it’s essential to take the following steps to protect your rights and seek compensation:

1. Seek medical attention: If you or your loved one has been injured, seek immediate medical care. Ensure that you follow the medical professional’s advice and keep all medical records and bills as evidence.
2. Preserve the product and evidence: Keep the defective product in a safe place, as it may serve as crucial evidence in your case. Also, preserve any documentation related to the product, such as purchase receipts, instruction manuals, and packaging.
3. Report the incident: Notify the manufacturer and the retailer of the defective product about the injury or loss. Also, report the incident to the appropriate government agency, such as the Consumer Product Safety Commission (CPSC) or the Food and Drug Administration (FDA) in the United States.
4. Document the incident: Write down the details of the incident, including the date, time, and location, as well as any witnesses’ contact information. Take photographs of the product, the injury, and the scene, if possible.
5. Consult our attorneys: Contact our law firm to discuss your case with one of our product liability attorneys. They can help you understand your legal rights, determine the parties responsible for the defective product, and guide you through the process of filing a claim or lawsuit.
6. Refrain from signing or accepting any “quick settlement” offers: Avoid signing any documents or accepting any settlement offers from the manufacturer, retailer, or their insurance company without consulting your attorney. Doing so may limit your ability to seek full compensation for your injuries or loss.
7. Keep a record of damages: Maintain a log of any expenses or damages incurred due to the defective product, such as medical bills, lost wages, property damage, and pain and suffering.
8. Be patient and follow your attorney’s advice: Product liability cases can be complex and time-consuming. Trust your attorney’s guidance and be prepared for a potentially lengthy legal process.

By following these steps, you can protect your rights and improve your chances of obtaining fair compensation for the injuries or loss caused by the defective product.

CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW

To find out if you or your loved one can file a Product Liability Lawsuit, call Parker Waichman LLP for a free legal consultation. Call 1-800-YOUR-LAWYER (1-800-968-7529) or use our online chat feature to speak with our Product Liability Lawsuit Attorneys, who will help you understand your rights and work hard to obtain the compensation you or your loved one deserves.