Or Click above to schedule a free consultation. Every moment matters after an injury. The sooner you reach out, the sooner we can help protect your rights and guide you toward recovery. We’re ready to listen and act!
Defective Medical Devices Can Cause Serious Harm
Patients trust that the medical devices used during surgery or implanted in their bodies are safe, well-tested, and effective. Unfortunately, defective medical devices have caused thousands of patients to suffer preventable injuries, permanent complications, and life-threatening outcomes.
Many devices require invasive procedures to implant or remove. When a device malfunctions, migrates, breaks, or fails prematurely, patients may face revision surgeries, infections, internal damage, or long-term disability. In the most severe cases, device failures have resulted in wrongful death.
Carabin Law represents individuals harmed by unsafe medical devices and works to hold manufacturers accountable when safety is compromised.
What Is a Medical Device Recall?
A medical device recall occurs when a manufacturer or the U.S. Food and Drug Administration (FDA) determines that a device presents a health risk or violates federal safety regulations. Recalls may involve removing a device from the market or taking corrective actions to reduce patient harm.
Not all recalled devices must be surgically removed. In some cases, doctors may recommend monitoring rather than removal if the risks of surgery outweigh the benefits.
Common Recall Actions Include
Medical device recalls may involve:
Inspecting devices for defects
Repairing or modifying components
Adjusting device settings
Updating warnings or instructions
Destroying defective products
Notifying patients and healthcare providers
Ongoing patient monitoring
While many recalls are issued voluntarily by manufacturers, the FDA has the authority to mandate immediate recalls when devices pose a serious threat to public health.
Types of Medical Devices Commonly Recalled
When these devices fail, patients often require corrective surgeries and long-term medical care.
FDA Medical Device Recall Classifications
The FDA assigns recall classifications based on the severity of the potential health risk:
Class I Recall
A dangerous defect that could cause serious injury or death.
Class II Recall
A defect that may cause temporary or reversible health problems, or a moderate risk of serious harm.
Class III Recall
A defect unlikely to cause health problems but still in violation of FDA regulations.
A recall remains active until the FDA determines the device no longer poses a safety risk.
Injured ? Contact Carabin Law
Medical device manufacturers have a legal responsibility to design, test, and market safe products. When they fail to warn patients and doctors about known risks, or release unsafe devices, patients suffer the consequences.
Contact Carabin Law today for a FREE, confidential case review.
Our defective medical device and mass tort attorneys are available to evaluate your claim and help you understand your legal options.