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Jama Software is always looking for news that would benefit and inform our industry partners. As such, we\u2019ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from MedTech Dive<\/a>, titled \u201cFDA Class I Recalls Hit 15-year High in 2022\u201d<\/a> \u2013 originally authored by Nick Paul Taylor<\/a> and published on March 3, 2023.<\/p>\n Last year, companies including<\/a> Abbott, 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.<\/p>\n 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.<\/p>\n 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.<\/p>\n 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.<\/p>\n Sedgwick identified the FDA\u2019s 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 to tell<\/a> patients about its respiratory device recall because the company\u2019s efforts to that point had been \u201cinadequate,\u201d the agency said.<\/p>\n <\/p>\n
\nFDA Class I Recalls Hit 15-year High in 2022<\/h2>\n
Dive Brief:<\/h3>\n
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\nRELATED: <\/strong>2023 Predictions for Medical Device Product Development<\/a><\/span><\/span><\/h4>\n
\nDive Insight:<\/h3>\n
\nRELATED: <\/strong>Practical Guide for Implementing Software Validation in Medical Devices: From FDA Guidance to Real-World Application \u2013 Part I<\/a><\/span><\/span><\/h4>\n
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