Medical device recalls hit two-year high in second quarter, report says

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According to a sedgwick report.

There were 268 recall events last quarter, a 34% increase from the first quarter of 2022, according to the report released Thursday. The total number of recalls is approximately 10% higher than the quarterly average for the past five years.

Safety concerns were the top reason for recalls, accounting for 48 during the quarter. Software issues were the second leading cause of recalls at 47, followed by labeling, quality and parts issues.

Over the past six years, only the second quarter of 2020 had more recalls issued due to safety concerns, the report said.

While the number of individual recalls increased, the total number of affected units last quarter – 10.1 million – fell to the lowest point since the first quarter of 2017.

Quality issues impacted 5 million units, most for any other reason provided. However, two recalls accounted for 4 million of these units: a recall for DNA collection kits (over 2.17 million units) and another for defibrillator electrodes (over 1.8 million units ). Other reasons cited were safety, labeling errors, sterility and out-of-specification devices.

Most second trimester recalls were class II, with 234 recalls, followed by 21 class I recalls and 13 class III recalls.

Class I recalls, the Food and Drug Administration’s most severe classification, accounted for just a fraction of total recalls last quarter, but it was the highest rating in more than 15 years, according to The report.

A recent orient oneself in the medical device industry, there have been recalls of COVID-19 tests. Companies like Mesa Biotech and Celltrion have recalled products for reasons varying risks of false negatives to test kits distributed in the United States without proper approval.

In June, North American Diagnostics reminded more than 122,000 rapid oral COVID-19 antigen test kits because the FDA has not cleared, cleared, or approved their distribution in the United States

There were nine recalls of unapproved or unsafe COVID-19 rapid tests in the second quarter, affecting about 982,483 units, according to Sedgwick’s report.

“With another highly contagious variant of COVID-19 spreading around the world, home COVID testing remains in demand,” the authors wrote. “That means some companies will try to cut corners to get their products to market quickly, sometimes without FDA approval.”

In July, there were 96 medical device recalls, affecting 10.8 million units. Software and quality issues were the top reasons for recalls last month, linked to 22 recalls and 21 recalls, respectively.

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