Regulatory Focus™ > News Articles > Medical Device Recalls Plunge to Near-Record Lows in First Quarter of 2015

Medical Device Recalls Plunge to Near-Record Lows in First Quarter of 2015

Posted 06 April 2015 | By Alexander Gaffney, RAC

Medical Device Recalls Plunge to Near-Record Lows in First Quarter of 2015

The number of medical device recalls appears to have plunged during the first quarter of 2015, a review of the US Food and Drug Administration's (FDA) data by Regulatory Focus has revealed.

FDA has since last year been publishing data about its drug and device recall reports through its new open data platform, openFDA. The data make it much easier to assess trends in enforcement measures, including the number of recalls classified by FDA.

A review of FDA's device recall classification data by Focus has found that with respect to device recall classifications, FDA has gone from record highs to near-record lows in just a single quarter.

During the fourth quarter of 2014, for example, FDA classified 968 separate device recall events—the largest number of recalls registered during a single quarter since at least 2013—the last full quarter with data available. The surge was due in part to several massive recalls, including the largest-ever single-day recall ever registered by FDA (262 recall events). Two other major recall events affecting, respectively, 213 products and 246 products, also helped drive the quarter to record highs.

But now, just one quarter later, FDA has registered an uncharacteristically low number of device recalls. FDA classified just 426 device recalls during the first quarter of 2015. Not since the first quarter of 2013, when it classified 367 recalls, has it classified so few.

Quarter Recall ClassifiedNumber of Medical Device Recalls Classified
2013: Q1367
2013: Q2579
2013: Q3688
2013: Q4609
2014: Q1706
2014: Q2557
2014: Q3845
2014: Q4968
2015: Q1426

It's worth noting that the classification of recalls often lags the recalls themselves—sometimes by several weeks or months, depending on FDA staff resources. Even then, FDA reported relatively few recall initiations, which are as-yet unclassified recalls, during the first quarter of 2015. Just 206 devices were recalled during Q1 2015, FDA data show.

The data do not, however, include information regarding the absolute number of devices recalled. A single recall may affect just a small handful of devices, or millions of devices.

The vast majority of products (92%) recalled during the 1st quarter of 2015 were classified as "Class II" recalls, meaning exposure to the product could cause "temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."

A further 4% of products were recalled as "Class I"—FDA's most serious recall classification, indicating that exposure to the products could potentially be fatal to patients. The remaining recalls were Class III, FDA's least serious risk classification.


openFDA data via

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.