Medical device recalls in Q2 reach levels not seen since 2018

Medical device recalls jumped 31.2 percent in the second quarter, the highest level in two years, according to a new report from Stericycle Expert Solutions.

Stericycle's 2020 Recall Index included analysis of data from the Consumer Product Safety Commission, the FDA, the National Highway Traffic Safety Administration and the U.S. Department of Agriculture.

Six things to know:

1. There were 341 medical device recalls in the second quarter, excluding state-level recalls of face masks and other personal protective equipment.

2. An estimated 1,200 medical device recalls will be issued by the end of the year, putting the industry on track to experience a 35 percent year-over-year increase.

3. At 29 million, the total number of units affected by second-quarter recalls was down 91.7 percent from units affected in the first quarter.

4. With the average recall size at about 86,000 units, the second quarter of 2020 saw the lowest number of affected units since the second quarter of 2019.

5. Sterilization issues accounted for 62.9 percent of all affected units, largely due to a single syringe recall that affected more than 16 million units.

6. Safety issues accounted for 48 recalls, or 14.1 percent of all events in the second quarter. Software issues were the No. 4 cause of recalls, behind manufacturing defects and mislabeling.

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