Medical device

U.S. sector spotlight

The Sedgwick brand protection recall index is the essential reference for medical device manufacturers seeking impartial and reliable perspective on past, present, and future product recall data and safety trends.

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2021 saw the highest number of U.S. medical device units recalled in the past five years, and the lowest number of product recall events.

The latest edition of our highly coveted product recall index report offers a comprehensive year-in-review of 2021 medical device product recall data and trends, and insightful predictions for the remainder of 2022. It is the only report of its kind that aggregates and tracks essential data to help medical device business leaders mitigate litigation and reputational damage caused by product recalls and other in-market product incidents.

While we strongly recommend you download and read the whole index, the following excerpt provides a glimpse into the key insights and analysis from the medical device sector.

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-22%

U.S. medical device recalls fell in 2021

19%

software issues: leading recall cause

603M

impacted medical device units in 2021

The U.S. medical device landscape

For the medial device sector, the growing number of cyberattacks on hospitals and healthcare systems remains a concern for regulators. Not only are devices at risk of being the source of a data or security breach, but there is also an added risk to patient care and health. The FDA is responding to cybersecurity concerns in a variety of ways, including creating a new leadership position focused on medical device security within the FDA's Center for Devices and Radiological Health (CDRH).

And while we can’t declare victory yet over the COVID-19 pandemic, the FDA is starting to think about what happens next for all of the medical devices that were granted Emergency Use Authorizations (EUAs), or fell within special public health emergency enforcement. Another change that the pandemic brought to medical devices was 3D printing at the point-of-care (PoC). The FDA is gathering input on how to regulate this and where the responsibility and liability reside for devices produced outside a manufacturing facility. Companies will have to think carefully about whether the value of having a large quantity of products made quickly at the PoC outweighs potential legal liabilities.

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Recall index report

Get unrivaled analysis and perspective on the latest medical device product safety trends and regulation.

Download the report

By the numbers: 2021 U.S. medical device recalls

The number of medical device recalls fell 7.7% in the fourth quarter compared to the previous quarter. The 217 product recall events recorded marks the lowest fourth-quarter figure since 2017.

The number of units fell dramatically, down 96.9% to 11.6 million units compared to more than 372 million in the third quarter. Overall, 2021 experienced the lowest number of annual product recall events in the past ten years (837), while simultaneously recording the highest number of units recalled (602.5 million).

Mislabeling was the top cause of product recalls in the fourth quarter, a change from software, which has been the leading cause for 21 of the last 23 quarters. The 43 events attributed to mislabeling accounted for 19.8% of fourth-quarter product recalls. Sterility was the leading cause of recalls in terms of units impacted, accounting for almost 4.1 million units, or 35.7% of recalled units. Parts issues were the second most common reason for product recalls, with approximately 2.6 million units in the fourth quarter.

Twenty-one medical device recall events (9.7%) in the fourth quarter were labeled with the FDA’s most serious Class I designation. These recalls impacted 582,383 units, or 5.0% of units recalled in the fourth quarter.

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Recall index report

Get unrivaled analysis and perspective on the latest medical device product safety trends and regulation.

Download the report

2022 strategic considerations

While product recall numbers are important, they are only part of the story. Here's what you should take away from medical device product safety developments in 2022:

  • Under the COVID-19 public health emergency, companies had some immunity from tort liability under the Public Readiness and Emergency Preparedness Act (PREP Act). Once the public health emergency is declared over, PREP Act immunity will disappear. Are you ready for the possibility of increased litigation for devices that were protected under the PREP Act? Have you reviewed your risk?
  • For well over a year, the FDA has been urging medical device companies with products marketed under EUAs to begin transitioning to “normal” by submitting marketing applications. Have you heeded this advice? Have you considered the consequences of not doing so? Are you prepared for the agency to return to its normal premarket review process?
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Recall index report

Get unrivaled analysis and perspective on the latest medical device product safety trends and regulation.

Download the report

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Whether you’re planning for — or currently facing — a product recall, market withdrawal or any other in-market product incident, our experts are on hand to support you.

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