Devices

Medical Device Recalls at Two-Year High: Sedgwick

The Sedgwick Recall Index for the second quarter of 2022 says that medical device recalls hit a two-year high with 268 events, up 34% from the 200 recalls in the first quarter. However, the report says, the number of affected units dropped by 96.8% to 10.1 million units, the lowest quarter in terms of units recalled since Q1 of 2017.

For the first time since Q2 2020, Sedgwick found, safety concerns were the leading reason for recalls, accounting for 48 events or 17.9% of all recalls. Software issues were the second most common reason for recalls and were linked to 47 events. Mislabeling was third with 42 events.

In terms of units, the top cause of medical device recalls was quality issues, with 5 million units recalled. While Class 1 recall events increased to 21, the number of units designated Class 1 fell 26.6% to 1.5 million units, from 2 million units in Q1 2022.

On the pharmaceutical side, Sedgwick says, the number of recalls was flat at 94 from Q1 2022 to Q2. The number of recalled units dropped sharply from 435.3 million units recalled in Q1 to 20.6 million units in Q2, the lowest number of units in the past five quarters.

CGMP deviations were the leading cause of recalls and units recalled in Q2. The report says that only three quarters in the last six years have seen CGMP deviations dominate both events and units. Failed specifications were the second leading cause of both events and units.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome