While total recalls and units affected declined in Q1 2025, the number of Class I events increased.
The number of medical device recalls in the US dropped nearly 9% in the first quarter of 2025, marking the lowest total recorded in three years, according to Sedgwick’s latest US Product Safety and Recall Index.
There were 236 medical device recalls between January and March 2025, down from 259 in Q4 2024. The total number of units affected fell even more significantly, decreasing 42.1% to 18.58 million—making it the third-lowest quarterly figure in the past eight years.
Despite the overall decline in recall activity and volume, Class I recalls—the FDA’s most serious designation—rose from 25 to 31 quarter-over-quarter. Only one quarter in the past two decades, Q1 2024, recorded more Class I events (33).
Device failures were the leading cause of recalls, responsible for 48 events, followed by software issues (31 recalls) and mislabeling (24 recalls). In terms of volume, safety concerns accounted for the most units affected, driven primarily by a recall of 6.22 million sampling lines and airway adapters and a separate recall of 1.17 million assorted medical tools.
Device failure was the second most common reason for medical device recalls by volume, with 3.65 million recalled units, followed by sterility concerns, which accounted for 1.37 million. Class III unit recalls saw the steepest drop, falling 95.7% compared to the previous quarter. Class I and II units also declined by 57.7% and 40.9%, respectively.
The full Sedgwick report also notes that reduced staffing and funding at federal agencies—including the US Food and Drug Administration—may impact recall response timelines and enforcement activity in the months ahead.
The Q1 2025 Recall Index tracks product safety trends across five industries: medical devices, pharmaceuticals, consumer products, automotive, and food and beverage.
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