Software the leading reason for Medical Device recalls

While the number of medical device recalls saw a downturn in Q3 2022 with 223 events (a 16.8% decrease from the 268 recalls in Q2 2022), the number of impacted units rose dramatically by 411.0% to 51.48 million.

Source: Sedgwick RECALL INDEX 2022 EDITION 3 | Product Recall Data, Trends and Predictions for US Industries

Software once again became the leading reason for recalls, accounting for 45 events, or 20.2% of all recalls. Safety issues were the second most common reason for recalls and were linked to 42 events. Mislabeling was third with 33 events.

Source: Sedgwick RECALL INDEX 2022 EDITION 3 | Product Recall Data, Trends and Predictions for US Industries

Want to know if your device or your competitor device is affected by a recall. A great free tool to use is PostMarketMonitor. During the COVID pandemic an area with noticeable recall trends was ventilators and ventilator parts. A search on PostMarketMonitor for adverse events and recalls would yield the following results.

Having all information in one central location that searches across multiple databases allows a medical device manufacturer to proactively address recall issues with similar products and technologies in the market, including information on Cybersecurity vulnerabilities in the software, and clinical performance as evidenced in scientific literature publications.

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