The number of medical device recalls fell 7.7% in the fourth quarter compared to the previous quarter. The 217 product recall events recorded marks the lowest fourth-quarter figure since 2017.
The number of units fell dramatically, down 96.9% to 11.6 million units compared to more than 372 million in the third quarter. Overall, 2021 experienced the lowest number of annual product recall events in the past ten years (837), while simultaneously recording the highest number of units recalled (602.5 million).
Mislabeling was the top cause of product recalls in the fourth quarter, a change from software, which has been the leading cause for 21 of the last 23 quarters. The 43 events attributed to mislabeling accounted for 19.8% of fourth-quarter product recalls. Sterility was the leading cause of recalls in terms of units impacted, accounting for almost 4.1 million units, or 35.7% of recalled units. Parts issues were the second most common reason for product recalls, with approximately 2.6 million units in the fourth quarter.
Twenty-one medical device recall events (9.7%) in the fourth quarter were labeled with the FDA’s most serious Class I designation. These recalls impacted 582,383 units, or 5.0% of units recalled in the fourth quarter.