FDA publishes Medical Device Recall Report

Recommendation

4/5 October 2023

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The FDA has published an overview over the evolution of medical device recalls between the fiscal years 2003 and 2012. In 2010, the FDA started an initiative to improve recall processes in order to enhance public health. The report should thus help to increase understanding between the FDA and the industry in order to better protect the population against unsafe or limited useful medical devices.

Please find below some of the significant report outcomes:   

• Over the 10-year period, the number of annual recalls has increased by 97%.
• Class I recalls have also increased over that period (Class I recalls have high priority as they are likely to lead to health hazards) They mainly concerned ventilators, infusion pumps and external defibrillators.
• In the last 3 years, the Center for Devices and Radiological Health (CDRH) also reduced the average times for the classification of a recall (Class I, II, or III, depending on the criticality): Class I recalls by 9 days and Class II by 26 days.
• The principal causes for recalls are related to device design, software, and non-conforming material or component issues. If the CDRH and the industry would address these problems jointly, they may be able to prevent as many as 400 recalls annually.

For the CDRH, the report is part of a larger initiative to enhance public health. In this respect, the CDRH has taken different measures to improve the recall programme; among other things a systematic analysis of recall information, the establishment of a "Recall Process Improvement team", the integration of improved methods for reporting recall information to the stakeholders and improved internal processes to incorporate recall root causes in premarket reviews.

More information can be found in the Medical Device Recall Report.