Total Recall
That’s a cheesy title, but who doesn’t love Total Recall?! It’s one of Schwarzenegger’s best parts, right after Conan the Barbarian and before Governor of California.
Despite implementing recommendations from a 2011 Government Accountability Office (GAO) study, FDA still struggles with recall oversight. A 2025 GAO report found that inadequate FDA resources prevent effective oversight, creating safety risks. For device firms, this means navigating recalls with little FDA support while facing increased reputational damage and litigation.
What happened?[1]
The GAO’s December 2025 report follows its 2011 study of FDA device recall oversight. The 2025 report finds that problems persist, made worse by the growing number of recalls. This forces some recall activities onto a “back burner.” For example, about 75% of recalls exceed FDA termination goals, with Class I recalls (the most serious category) exceeding the deadline by about 175 business days on average.
FDA’s staffing crisis worsened after the report’s 2020-2024 review period. In October 2024, FDA’s Office of Inspections and Investigations reorganized, centralizing all recall coordinators and recruiting additional staff. But the 2025 hiring freeze killed that work, and FDA now tells GAO that staffing plans are obsolete.
These setbacks create confusion about what recalls mean, how long they run, and the steps along the way. There’s also a growing risk from the plaintiff’s bar, which uses recalls to bring multi-plaintiff, widespread suits. Device firms especially face these risks. Unlike drugs and other medical products, devices often change and digital devices use continuous learning to evolve, meaning more changes, some of which will be handled as recalls.
Adding complexity, device firms see more recalls than other medical product companies. The GAO report notes that device recalls outnumber biologics or drugs in any given year, with FDA officials citing device hardware and software complexity as a contributing factor.
What does this mean for device firms?
Recalls are bad for business, threatening regulatory oversight, brand damage, and litigation. With FDA capability damaged, regulatory oversight is stunted. The GAO reports that the number of recalls is rising while FDA resources have dropped, and this creates a risk of oversight gaps. If there’s another event like the Philips CPAP recall, with widespread injury and over 500 reported deaths, FDA will respond. Absent such harm, FDA engagement is unlikely.
But anemic regulation doesn’t prevent reputational harm or lawsuits from device users. Because there are substantial closeout delays, many recalls remain open long after the underlying problems have been fixed. This causes reputational harm when patients believe that device firms aren’t fixing ongoing problems.
To be clear, sometimes devices fail, producing safety risks. Recalls are then necessary and device firms must fix product defects. But sometimes device technology and iteration lead to recalls without poor performance or health risks. Even FDA acknowledges that device changes can improve compliant devices. Calling the improvements recalls is incorrect, but it happens enough that FDA published a guidance distinguishing device recalls from product enhancements.
As to the plaintiff’s bar, look no further than the growing number of ads telling patients, “If you’ve ever used a device and something hurts, you’re entitled to a payout.” There are law firms building their businesses by finding recalled devices and suing device makers.
Reputational damage and litigation risks aren’t going away even with impaired FDA oversight. So, device firms need to protect their reputations and mitigate risks.
What should device firms do?
The first step is improving recall closeouts and that’s (relatively) low-hanging fruit. Making closeouts faster and more predictable will build patient confidence and reduce charges that device firms leave unsafe products on the market. Next is better staffing and recall process reform. Device user fee negotiations are the right place for this discussion, and adding these topics doesn’t violate the industry bar against directing user fees to postmarket activities. Actually, recall fixes are the opposite; they reinforce device integrity, lowering the risk of lawsuits and adverse agency action. As important, FDA should commit to better communication throughout the recall process, for example by announcing when safety concerns have been resolved. Historically, resource limits have prevented such communication.
Industry associations and similar groups can amplify FDA recall messaging, including that finished recalls sometimes stay open pending FDA action. Also, because devices are technological and often iterate, there’s a higher volume of device recalls compared to other medical products. This doesn’t mean that devices lag other products’ quality, safety, or efficacy. To the contrary, such recalls can signal effective postmarket action.
The GAO counsels other steps, such as workforce planning for recall oversight, and it asks if FDA needs different authority to compel firms to act. HHS gives these recommendations lip service and there’s 0% chance it will follow them. That leaves user fee negotiations and association communications to address recall process failures. FDA can’t fix these problems alone, and waiting for the agency exposes industry to more reputational harm and litigation. Savvy firms will get ahead of these problems before the next high-profile crisis produces reactive, bad results.
[1] Note: I sometimes use artificial intelligence in drafting this column. My primary tool is Claude AI. I review and verify all findings, interpretations, and final wording.