Home » Blog » FDA Class I Recalls Hit 15-year High in 2022

FDA Class I Recalls Hit 15-year High in 2022

April 13, 2023 Decoteau Wilkerson

FDA

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced fromMedTech Dive, titled“FDA Class I Recalls Hit 15-year High in 2022”– originally authored byNick Paul Taylorand published on March 3, 2023.

FDA Class I Recalls Hit 15-year High in 2022

The exterior of the Food and Drug Administration headquarters is seen on July 20, 2020 in White Oak, Maryland. Sarah Silbiger via Getty Images

Dive Brief:

  • The number of Class I medical device recalls by the U.S. Food and Drug Administration hit a 15-year high in 2022, according to areportby Sedgwick.
  • 2022年,美国食品药品管理局负责监督70类我回忆说,highest risk classification, compared to an average of 47 over the previous five years. Eighteen of the Class I recalls happened in the fourth quarter.
  • Mislabeling was the most common reason for recalls in three of the past five quarters.

RELATED:2023 Predictions for Medical Device Product Development

Dive Insight:

Last year, companiesincludingAbbott, Baxter, GE HealthCare, Medtronic and Philips were the subject of Class I recalls, a category that the FDA reserves for problems with the potential to cause serious injury or death. The activity added up to a record year for Class I recalls.

Sedgwick reported the 15-year high for Class I recalls after tallying up the data for the fourth quarter. Over the final three months of the year, the total number of recalls of any type rose 8.1% sequentially, and the number of recalled units increased by around 10 million to 61.98 million.

Mislabeling was again the most common cause of recalls in the fourth quarter, as it has been for three of the past five quarters, followed by quality. There was a decline in the number of recalls related to software, the most common cause of recalls in the third quarter. Having been responsible for 46 events over that prior period, software accounted for 15 recalls in the final three months of the year.

RELATED:Practical Guide for Implementing Software Validation in Medical Devices: From FDA Guidance to Real-World Application – Part I

Based on data for January, the increase in recalls between the third and fourth quarter may continue in 2023, the report said. Sedgwick counted 135 recalls in January, compared to a monthly average of 80 in the fourth quarter. The number of recalled units is also tracking above the rate seen in the fourth quarter.

Sedgwick identified the FDA’s use of Section 518 authority, which allows it to order manufacturers to notify patients and providers of risks, as one of the most significant developments in medical device recalls. The FDA used the power one year ago to order Philips totellpatients about its respiratory device recall because the company’s efforts to that point had been “inadequate,” the agency said.


Previous Article
Jama Connect® Features in Five: Using Jama Connect with a Quality Management System (QMS) for Medical Device & Life Sciences
Jama Connect® Features in Five: Using Jama Connect with a Quality Management System (QMS) for Medical Device & Life Sciences

Jama Connect® Features in Five: Using Jama Connect with a Quality Management System (QMS) for Medical Devic...

Next Article
The Top Challenges in Industrial Manufacturing and Consumer Electronic Development
The Top Challenges in Industrial Manufacturing and Consumer Electronic Development

The Top Challenges in Industrial Manufacturing and Consumer Electronic Development From supply chain disrup...

Return to Home