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# Class 3 Device Changes Up Recall Risk: Study
- URL: https://www.fdaweb.com/class-3-device-changes-up-recall-risk-study/
- Published: 2023-04-12T12:00:00.000Z
- Updated: 2026-09-14T18:25:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154199

Researchers from the University of Missouri-Kansas City and other facilities say post-approval modifications to Class 3 medical devices approved through the premarket approval (PMA) supplement process are associated with an increased risk of device recall. The study, published by *JAMA Network Open*, says an “increase of one supplement per year, on average, was associated with a 28% increased risk of any recall and a 32% increased risk of Class 1 recall.”

Secondary findings worth mentioning, the authors say, are:

- the median time until first recall was less than two years from the original device approval;
- cardiovascular devices had 3.5 times the risk of a Class 1 recall; and
- device design flaws caused nearly 30% of recalls and over half of Class 1 recalls.

“Physician awareness, improved preapproval testing, and post-market surveillance strategies should be used to mitigate risks to patient safety and public health,” the authors conclude.