Drugs

Device, Drug Recalls Down in 2021: Sedgwick

The 837 medical device recalls in 2021 were 20.2% lower than the 10-year annual average of 1,049 recalls, according to the Sedgwick recall index for 2021. The report shows that software issues remained the top cause for recalls, accounting for 162 events (19.4%). The number of affected units was up 29.1% from 2020 to 602.5 million, nearly doubling the average annual figure of 307.3 million for the past 10 years.

The number of medical device recalls fell 7.7% in the fourth quarter compared to the previous quarter, Sedgwick says. The 217 recalls were 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.

Mislabeling was the top cause of recalls in the fourth quarter, a change from software, which was the leading cause for 21 of the last 23 quarters. The 43 events attributed to mislabeling accounted for 19.8% of fourth-quarter recalls. Software was the second most common reason for recalls at 39 events, followed by quality concerns (31), and parts issues (25).

Some 21 events (9.7%) in the fourth quarter were labeled with FDA’s most serious Class 1 designation. These recalls involved 582,383 units, or 5% of units recalled in the fourth quarter.

As is typically the case, Class 2 recalls accounted for the largest percentage of recalls at 192 events and the largest number of units at 11.0 million in the fourth quarter. The remaining four recalls, which involved only 232 units, received FDA’s Class 3 designation.

Of fourth quarter recalls, 77.4% were distributed nationwide, and 52.5% affected an international customer base.

Sedgwick’s review of drug recalls found that in 2021 they were 11.9% below their 10-year average (274 recalls compared to 311). Failed specifications was the leading cause of drug recalls at 63 events or 23%. Affected units in 2021 doubled those registered in the previous year, 264.6 million compared to 132.8 million, and exceeded the 10-year annual average of 144.1 million.

Fourth-quarter drug recalls dropped 23.3% to 66 events, according to the report. While the number of recalls dropped, the number of affected units rose sharply to 102.6 million, a 169.1% increase over the third quarter.

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