- The number of medical devices recalled in the U.S. surged in the first quarter, resulting in one of the highest average recall sizes of the past 15 years, according to a report by Sedgwick.
- Companies recalled 314.8 million devices in the period, up from 11.6 million over the final three months of last year. The jump was attributable to the Class 3 recall of 288 million units of a Becton Dickinson connector for a catheter port.
- The analysis showed mislabeling was the No. 1 reason for recalls for the second consecutive quarter. Until the last six months, software issues typically spurred most recalls.
The recalled devices surge in the quarter mostly was attributed to a single recall of BD connectors for a catheter port. That one event boosted the average recall size to 1.6 million units. According to Sedgwick, the average has topped 1.5 million once in the past 15 years.
The trends reversed in April. That month, the Food and Drug Administration oversaw 147 medical device recalls, compared with a first-quarter monthly average of 67. While the number of recalls rose, the number of recalled units fell from a per-month average of 104.9 million units in the first quarter to 7.9 million in April. Recalls of 2.2 million oral DNA collection kits and 1.8 million defibrillator pads accounted for most of the volume in April, the report said.
The FDA oversaw six recalls of rapid COVID-19 tests in April, compared to eight in the first quarter. In both periods, most of the COVID-19 test recalls were triggered by safety concerns about unauthorized diagnostics. Sedgwick said it expects the number of recalls related to COVID-19 tests to continue to rise.
Thirty-five recalls in the first quarter were related to mislabeling, making it the top reason for FDA alerts over the three-month period, the report found. Mislabeling was also the top reason in the fourth quarter of 2021. Before that, software dominated the previous five years, falling off the top of the quarterly lists of the reasons for recalls only once. In April, safety topped the list, followed by software issues.
Overall, the number of recall events fell 7.8% sequentially in the first quarter, dropping from 217 to 200. According to Sedgwick, in the past 10 years there have been five quarters with fewer than 200 recall events.