Devices

Medical Device Recalls Up in 2nd Quarter: Sedgwick

The Sedgwick Recall Index says Quarter 2 recall events soared 34% to a two-year high from 200 events in the last quarter to 268 events in Q2. The document says the number of affected units dropped, however, by 96.8% to 10.1 million units, the lowest quarter in terms of recalls since Q1 2017.

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

In terms of units, Sedgwick says, the top cause of medical device recalls was quality issues, with five million units recalled, 49.5% of all units recalled in Q2.

On the drug side, the number of recalls remained at 94, the same as in Q1. Sedgwick says that despite events remaining consistent at 94, affected units fell 95.3% from 435.3 million to just 20.6 million.

At 29 events, current good manufacturing practice (CGMP) deviations were the leading cause of Q2 recalls for both events and units. CGMP deviations dominated both events and units in only three other quarters in the last six years. Failed specifications were the second most common cause for 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