574 Recalls of Medical Devices in 2021, Significant Differences between Domestic and Foreign Recalls

In recent years, the number of recalled medical devices at home and abroad has gradually increased. In 2021, 475 different types of medical devices were recalled, among which the more serious first-class recall events, such as the recall of the atrial septal puncture needle product (model tsnc-18-71.0) of Cook (China) due to the rust problem, Medtronic’s covered stent system was recalled due to manufacturing fusion problems. Although other recall events were rated as level II and level III, their impact should not be underestimated.

Overseas recall was more than domestic recall

In 2021, NMPA issued 574 product recall reports, involving 351 medical device manufacturers. Among which, there were 378 level III recall events with clear information, 169 level II recall events and 24 level I recall events.

Overseas recall

According to the origin distribution of overseas recalled products in 2021, 172 products were produced in the United States, with the largest number. There were 53, 22, 21 and 16 products in Germany, Japan, Britain and France respectively. According to product categories, 314 kinds of products were involved in overseas recalls throughout the year, of which medical angiography X-ray machines were recalled the most, with a total of 5.

 Domestic recall: mainly low value consumables

Among the national recalls in 2021, Guangdong Province was the most involved, involving a total of 47 recalls, followed by Jiangxi Province, Shanghai, Jiangsu Province and Chongqing, with 30, 29, 27 and 20 respectively. In terms of subdivided fields, the recalled products involved 163 categories, among which disposable medical masks, medical surgical masks and specific electromagnetic wave therapeutic devices were among the top three. According to the medical equipment data cloud, among the top three recalled, the registered effective number of disposable medical masks was 3058, the registered effective number of medical surgical masks was 2241, and the registered effective number of specific electromagnetic wave therapeutic devices was 21. The manufacturers of specific electromagnetic wave therapeutic devices were the least, and the recall probability was the highest.

 Summary

According to the data, in 2021, the II and III levels of medical device product recall events accounted for the vast majority, of which overseas recall events were more than domestic recall events; the domestic recalled products were mainly low-value consumables products such as class I and II with low scientific and technological content. The recall province is also a large production province; overseas recalled products are concentrated in developed countries such as Europe and the United States, and the recalled products involved are almost completely different from domestic recalls, including some medium-end medical devices with relatively scientific and technological content.

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