US FDA Medical Device Recalls: Trend and Impact Analysis

Product Innovation will Reduce Medical Device Recalls

Rising incidents of patient deaths are raising questions about medical device efficacy, specifically Class II and Class III medical devices. All medical devices commercialized in the US market must adhere to 510(k) compliance. The US Food and Drug Administration (FDA) posts summaries of information about the most serious medical device recalls.

This study analyzes the latest US FDA recalls in the medical device market. It does this by examining the FDA's information summaries. This list includes devices recalled during the study period (2020–2028) as they presented specific risks to patients. The device types (according to US FDA classification) studied include:

• Class I recalls
• Class II recalls

In terms of recalls, devices that could cause serious health issues and even patient death are listed. Medical device recall notices reflect the date of posting on the government list and not the recall initiation date.

FDA Class I Recalls: The FDA Class I is the most crucial recall type. Using Class I medical devices may cause serious injuries or even death.

This recall occurs when a high probability exists that a violative medical device, through exposure or use, causes serious adverse health issues or patient death. Under statutory authority, the FDA can request, conduct, or order a Class I recall. As this recall type includes FDA requests, most companies voluntarily recall their device.

FDA Class II Recalls: An FDA Class II recall occurs when a medical device presents patients with a substantial health and safety hazard. Class II medical device recalls cover devices that have even a slight chance of causing serious injury or producing adverse health consequences, which may be temporary and medically reversible. The FDA issues a Class II recall where the risk of death or severe injury from the device usage is not immediate, but the danger remains.