Top FDA Recalls and CPSC Recalls that KBA Is Investigating

WhatThere have been several product recalls. Some are consumer products we have seen through the U.S. Consumer Product Safety Commission. Others are medical devices we learned about through the FDA. Here’s a list of top recalls for KBA:

1. Impella recall
2. RMU recall
3. Accolade Pacemaker recall
4. Boston Scientific PolarX recall
5. BioZorb recall
6. Cartiva Toe Implant Recall
7. Stanley Switchback and Trigger recall
8. Nerf Helmet
9. Medical King Bed Rail Recall
10. PowerXL Air Fryer Recall

There is a mix of recalls from FDA and CPSC. Our product liability lawyer works on both kids of recalls, medical devices and consumer products. Different agencies regular each, but in both, we work to establish liability via industry standards and best practices. We work to tell your story to capture the full scope of damages.

What does the FDA do and What is an FDA recall?

What Does the FDA Do?

The Food and Drug Administration (FDA) is a federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of various products, including food, drugs, medical devices, cosmetics, and more. The FDA plays a critical role in regulating industries and providing oversight to prevent harm to consumers.

Key Functions of the FDA:

1. Approving Medical Products: Before drugs and medical devices are made available to the public, the FDA evaluates their safety and effectiveness.
2. Monitoring Products Post-Approval: Even after approval, the FDA continues to monitor products for potential risks or adverse effects through reports and studies.
3. Issuing Guidelines: The FDA provides guidance to manufacturers to ensure compliance with safety and quality standards.
4. Conducting Inspections: To maintain high standards, the FDA inspects manufacturing facilities and processes.
5. Enforcing Regulations: If a product violates laws, the FDA can take action, including issuing warnings, fines, or legal penalties.

What Is an FDA Recall?

An FDA recall occurs when a product is removed from the market because it poses a risk to public health or fails to meet regulatory standards. Recalls can involve food, drugs, medical devices, or other products under the FDA’s jurisdiction.

Types of FDA Recalls:

1. Voluntary Recalls: Manufacturers or distributors initiate these recalls when they discover a safety issue with their product.
2. FDA-Requested Recalls: If the FDA identifies a serious problem, they may formally request a recall.
3. Mandatory Recalls: In rare cases, the FDA has the authority to mandate a recall, especially when the manufacturer does not cooperate.

Reasons for a Recall:

• Contamination or defects in the product
• Packaging errors, such as incorrect labeling
• Adverse effects reported by consumers
• Failure to comply with manufacturing standards

Recall Classifications:

Recalls are categorized based on the severity of the risk:

• Class I: The most serious, where the product could cause severe harm or death.
• Class II: Less severe, but the product may cause temporary health issues.
• Class III: The least severe, where the product is unlikely to cause harm but still violates FDA regulations.

Why This Matters to You

If you’ve been injured or suffered harm due to a defective product, understanding the FDA’s role and the recall process can be critical to your case. Our experienced product liability lawyers can help determine if negligence by a manufacturer or other party contributed to your injury. Contact us for a free consultation to learn more about your legal rights.

What does the CPSC do? What is an CSPC recall?

If you or a loved one suffered an injury from a recalled product, you should speak to a product liability attorney. Our legal team is happy to help, submit a form to contact us now. Call us at 855-KBA-LAWS (522-5297) or via email at Info@KBAAttorneys.com