Q3 Medical Device Recalls Increase 36%, Software Issues Remain Top Reason
For the past four quarters, medical device recalls were on the decline—but not for Q3 2021. According to Sedgwick’s Q3 recall index , the third quarter broke some records: Recalls increased nearly 36% from 173 to 235 quarter-over-quarter, and the number of impacted units was at its highest in a quarter since at least 2005, skyrocketing almost 136% to more than 372 million.
“Amid the negative publicity about recall-related challenges, the FDA has placed a renewed emphasis on effective recall management. To start, the FDA held two public meetings in less than a year in hopes of identifying ways to improve the recall process. And it is very likely these meetings will lead to substantive change down the line, whether in terms of legislation, rulemaking, or new enforcement actions,” the Sedgwick report states. “Manufacturers would be wise to closely monitor the recommendations that come from recent meetings, as well as ones that are upcoming. They should also find ways to enhance their own internal processes, thereby limiting regulatory scrutiny, enforcement actions, legal liability, and reputational damage.”
Notable Recall Numbers (Q3 2021)
- Software issues were top reason with 41 recalls (17%)
- Mislabeling issues came in second with 36 recalls
- Parts issues accounted for 34 recalls and were the leading cause of recalls when looking at units impacted
- Quality concerns accounted for 29 recalls and impacted 17.9 million units
- Safety concerns accounted for 29 recalls
- Recalls by Class: 20 Class I, 210 Class II, and 5 Class III
- 86% of recall products were distributed nationwide; 48.5% internationally
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