FDA medical device product recalls dropped by double digits last year to the lowest number since 2013, according to a Medical Design & Outsourcing analysis of newly released recall data from the regulatory agency.
Device products recalled in fiscal year 2021 (ended Sept. 30) totaled 2,607, a 14.3% drop from the 3,042 recalls reported in fiscal 2020.
The drop in device recalls occurred at the same time the FDA put more emphasis on fighting the COVID-19 pandemic and improving device safety protocols, according to FDA’s Center for Devices and Radiological Health (CDRH) annual report. CDRH Director Dr. Jeff Shuren said in September that the agency was “starting to turn the corner” on catching up on submissions, after having focused on the pandemic and issuing emergency use authorizations (EUA) in record times. But that was also before the virus’s omicron variant hit.
The 2,607 figure from last year is the fewest product recalls dating back to fiscal 2013, when 2,304 devices were recalled. Fiscal 2013 was the first full year for which the FDA made these tallies public.
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