NotiSphere’s Solution to the 'Shockingly Slow and Ineffective' Medical Device Recall Process Highlighted in Fast Company

New report details the broken process that’s leaving as many as 600,000 recalled items on healthcare providers’ shelves

Clinician Using NotiSphere

A long-overdue spotlight is being shone on the dangerous inefficiency and ineffectiveness of the current U.S. medical device recall system. Taking center stage in these discussions, including a new report by Fast Company, is the need for a centralized, two-way digital platform like the one offered by NotiSphere

“The current state of medical device recalls is painful to behold. Once a manufacturer issues a recall, it can take an average of two months just for the Food and Drug Administration (FDA) to publish the recall notice on its website,” writes Fast Company contributor Shalene Gupta. “It can take even longer for products to come off the shelves. In the meantime, these products might end up still being used — with deadly consequences.”

Gupta’s insightful article adds to the scrutiny of the medical device recall process that has been mounting in recent months. In late 2023, U.S. Representative Jan Schakowsky and U.S. Senate Majority Whip Dick Durbin introduced the "Medical Device Recall Improvement Act.” Then, earlier this year, the Government Accountability Office announced an inquiry into FDA's oversight of medical device recalls. 

“Most people are shocked when they learn how dysfunctional the process for recalling medical products is in the U.S.,” said NotiSphere Founder and CEO Guillermo Ramas. “I’m relieved to see U.S. legislators and prominent industry publications like Fast Company turning their attention to this issue and helping bring solutions to light.”

One such solution being touted by reporters and healthcare providers is the NotiSphere platform, which enables rapid two-way digital communication between suppliers and providers. Last month, a group of leading U.S. healthcare providers, including Novant Health, BJC HealthCare, and Munson Healthcare, united to advocate for the adoption of NotiSphere as a universal platform to manage product recalls and other supply-disruption alerts.

“Based on our audits, we estimate as many as 600,000 recalled medical products could still be sitting on hospital shelves,” Ramas said. “These products put patient lives at risk. As healthcare providers become aware of how extensive and serious this problem is, they’re calling for change. At NotiSphere, we’re proud to be a part of this revolution.”  

Healthcare providers interested in joining the network of providers calling for a universal platform to manage product recalls are invited to sign up here: 

About NotiSphere

NotiSphere offers an innovative digital platform that directly connects medical device suppliers and healthcare organizations, enabling direct communication and management of supply disruptions in real time. NotiSphere's mission is to minimize the impact of healthcare supply chain disruptions due to communication challenges between industry stakeholders. This is accomplished by automating communications, leveraging standards, and designing best practices and processes to promote industry-wide adoption. Learn more at

Source: NotiSphere