Broken Clocks Aren’t Always Right Twice a Day

CDRH’s recall-closure clock is broken and no one’s coming to fix it.

Asking how long it takes FDA to close a device recall gets a wince before an answer. That wince is earned. A 2025 GAO report confirms what device firms know: FDA’s three-month recall closure target is more suggestion than deadline, the backlog is enormous, and the problems predate this administration. A 2011 GAO review is as concerning and FDA medical product oversight (including recalls) has sat on GAO’s High-Risk List since 2009.

What happened?^[1]

Last December, GAO reported on FDA’s 2020-2024 device recall numbers. The results aren’t great. FDA missed its 3-month recall termination target 74% of the time and about 60% of the surveyed recalls remained open as of the report’s publication. GAO’s explanation – FDA short staffing pushing required work into the can’t-get-to-it bucket –is familiar. GAO recommends that HHS build a recall strategy for problems including delayed closures. Advising HHS to help FDA is ironic given its steady work to derail the agency.

Late closures aren’t a new recall problem. GAO checked FDA recall handling in 2011 and noted a 17-month timeline for Class I recalls (the highest-risk category), and a 2018-2022 review shows a longer timeline. This is a structural, resourcing, and prioritization challenge that’s outlasted multiple commissioners and that’s rediscovered whenever high-profile recalls occur.

What does this mean for device firms?

Senators Durbin and Blumenthal requested the GAO report, using it to push their Medical Device Recall Improvement Act, which mandates electronic recall notifications and bolsters FDA recall staffing. Here’s a safe prediction: that act never sees the light of day. That’s not cynicism, it’s pattern recognition. The act’s been introduced and reintroduced since 2023 with no floor vote , and it sits in a Congress with no appetite to expand FDA’s authority or budget. Plus, FDA lacks full data on adequate recall staffing, which doesn’t incline Congress to send more money.

Device firms face a tough reality: recall closures will keep lagging recall completion. FDA admit that it deprioritizes this work in favor of higher-risk tasks. That’s a rational choice for an under-resourced agency, but it leaves a process gap for device firms to fill.

What should device firms do?

The most important shift is in communications, not operations. Device firms need to clarify – to patients, healthcare providers, and others – that FDA recall closure isn’t the measure that matters because many recalls stay open even after firms finish remediation.

Firms that don’t disclose FDA delays risk others telling their stories. Competitors can misrepresent open recalls as showing product defects after corrections are complete. Or patients don’t see that “open” recalls may concern long-fixed devices. And it’s unrealistic to look to FDA for proper messaging. An agency that struggles with on-time audit checks won’t timely report when manufacturers finish recalls. So, device firms must add closure communication to their recall playbooks. That includes announcing when corrections are done, demonstrating recall effectiveness, and explaining that FDA closure delays don’t mean ongoing product problems.

In other columns, I’ve recommended that device firms collectively engage FDA. That makes sense for matters uniformly affecting firms, with similar impact and results. Recalls are different. These aren’t policy asks; recalls concern unique devices and firm-specific events. Firms need to step outside the collective and speak for themselves.

Some more concrete steps: firms must track corrective action, not FDA recall termination, as their progress measure, and employees must use this measure for stakeholder communications (to avoid messaging that recalls are open after fixes are done). Firms should prepare plain-language notices – for sales staff, call centers, and patient/provider communications – that explain product problems, fixes, when the fixes were verified, and why FDA records don’t yet reflect this work. Last, firms should check how competitors and analysts describe their recalls. If open recalls get miscast as continuing safety issues, firms must counter with timely, factual accounts.

None of this fixes FDA’s recall-closure backlog and nothing suggests that the backlog will shrink. But device firms don’t need FDA to fix recall handling to protect their own reputations. They need to speak for themselves so that FDA silence and competitor misdirection don’t speak for them.

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^[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.