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What Are the Different Classes of Medical Product Recalls?

Philadelphia Medical Product Liability Lawyers at Brookman, Rosenberg, Brown & Sandler Advocate for Clients Injured by Defective Medical Devices.

The safety of medical products, devices, and medications is federally regulated by the U.S. Food and Drug Administration (FDA). When notified of a product’s potential defectiveness, contamination, or potentially harmful health concerns, the agency may take action to compel the manufacturer to issue a product recall to ensure public safety.

According to the FDA, the agency receives hundreds of thousands of reports of serious injury, malfunction, and death suspected to have been caused by defective medical products. Issues stemming from defective medical devices are so common that the FDA developed a reporting system specifically for the identification and investigation of medical devices, known as the Medical Device Reporting (MDR) system. The MDR system requires manufacturers and importers of medical devices, as well physicians and patients, to report known defects and safety concerns.

The majority of the time, recalls are voluntary, and the manufacturer will notify the FDA to begin the recall process. The FDA initiates product recalls only in rare instances. Products subject to recall under FDA jurisdiction include food, drugs, and cosmetics. Medical products include:

  • Vaccines.
  • Medical devices.
  • Human blood and blood products.
  • Human tissue for transplantation.

When issuing a recall, the FDA uses three separate levels of classification, based on the severity the defective product poses on consumers’ health.

Class I Recalls

The most urgent recall classification, Class I recalls are issued for defective products that could lead to serious health conditions or fatalities, such as toxin contamination of over-the-counter medications. The FDA steps in on Class I recalls overseeing the recall, lead the investigation, and to enforce the manufacturer undergoes measures to protect the public.

Class I medical device recalls address defective medical devices that pose a serious threat of injury or death to patients using the device, particularly patients with surgically implanted devices. In such cases, the FDA or the manufacturer are required to immediately remove the device from markets entirely, as defective medical devices violate federal safety laws.

In some instances, however, manufacturers may be able to take corrective actions to fix or correct a device without removing its availability in markets. Medical device recalls may include all medical devices produced by the manufacturer or only specific models, lot numbers, or product lines.

Class I medical device recalls typically result in removal rather than corrective actions, especially in the case of implanted medical devices, which cannot be removed and returned to the manufacturer for repair. In such instances, doctors determine whether removal or replacement is safe or necessary on a case-by-case basis.

Class II Recalls

Class II recalls pertain to defective products the FDA deems as having a lower chance of causing serious injuries or death but could cause a short-term health concern. As with Class I, the FDA oversees the recall and corrective measures.

Class III Recalls

The least serious classification, Class III recalls pertain to minor defects that violate federal regulations but are unlikely to cause harm to consumers’ health.

In some cases, manufacturers may opt to limit or avoid a formal medical device recalls by simply pulling it from their product line and stop selling it. Such measures are considered “silent recalls” or “market withdrawals.”

In some circumstances, FDA recalls result in lawsuits if the consumer experienced an injury or economic loss due to the product or device. If you were injured by a recalled medical device or product, consult an experienced attorney as you may be eligible for compensation.

Philadelphia Medical Product Liability Lawyers at Brookman, Rosenberg, Brown & Sandler Advocate for Clients Injured by Defective Medical Devices

Defective products can cause serious medical conditions, injuries, or even death to unsuspecting consumers. If you have been injured by a defective medical device, one of our Philadelphia medical product liability lawyers at Brookman, Rosenberg, Brown & Sandler can help. Call us at 215-569-4000 or contact us online to schedule a free consultation. Located in Philadelphia, we serve clients throughout Pennsylvania and New Jersey, including Delaware County, Chester County, and Philadelphia County.