Recalls Are Rising. Panic Doesn’t Have To.

FDA recalls are not rare, black-swan events. They are an ongoing operational reality. As a former FDA regulator, I’m convinced that the recall is rarely the most damaging part. The real cost comes from how unprepared organizations are to execute a recall process quickly and in a convincing manner.

Recalls protect patient safety but also put a company’s financial health, reputation, and standing with the FDA at risk. When trust is lost, scrutiny escalates, and rushed, incomplete fixes can prompt the agency to take decisive action; and in rare cases, pull a product off the market.

Why recalls keep rising

According to FDA data, more than 2,500 medical device recalls are issued annually, with periodic surges driving that number even higher.

Information on FDA regulatory review staffing is not generally available. Some estimates range from 500-800 engineers, scientists, clinicians, and doctors. Submission estimates range as high as 19,000 per year. While submission reviewing effort varies, this still represents a staggering amount of regulatory work. Between essentially mandatory review completion times, staff loads, increasing device complexity and applications, the FDA must necessarily rely on manufacturer quality systems and clinical data rigor for device assurance. While FDA asks for voluminous design documentation, they don’t always have the bandwidth or technical depth to scrutinize submissions in a comprehensive manner. Not surprisingly, some poorly designed devices slip through the process, and subsequently fail in the field. That being said, device failure is fundamentally a fact of life.

Recalls expose system weakness—not just product defects

When FDA evaluates a recall, they are not only looking at the defect. They are assessing whether the manufacturer can:

• Identify the affected product quickly and accurately
• Isolate the root cause across design, manufacturing, software, and distribution
• Execute CAPA and change management in a controlled, documented way
• Demonstrate ongoing TPLC process effectiveness—not just intent

FDA data shows the most common recall root causes remain remarkably consistent: device and software design issues, process control failures, nonconforming components, software changes, and packaging or labeling errors. Software design alone remains the single largest category.

These are not exotic failures. They are predictable outcomes of complex, human-dependent systems that lack computationally driven rigor.

Regulators are tasked with reviewing increasingly sophisticated products—often without the engineering depth, tooling, or time required for deep systems analysis. At the same time, manufacturers face submission processes that demand massive documentation. Many devices have millions of lines of code in them. Even if reviewers had unlimited expertise, the sheer scale makes comprehensive review unrealistic.

The result is a fragile equilibrium: approvals move forward, anomalies slip through, and recalls surface with real-world use.

Panic mode is not a strategy

I’ve watched capable teams make poor decisions under recall pressure—not because they lacked expertise, but because their systems lacked sufficient rigor to support them.

When documentation isn’t connected, teams lose days proving what should be obvious. When change management isn’t automated, fixes stall. When CAPAs aren’t traceable end-to-end, organizations either over- or under-correct—both of which invite further scrutiny.

Recalls as strategy

The recall process is predictable: investigation, risk assessment, containment, correction, verification, update / patch distribution closure. The artifacts and timelines are all known. Yet many companies still treat recalls as one-off emergencies instead of repeatable operational workflows.

The companies that win in regulated markets won’t be the ones with zero recalls—that’s unrealistic. They’ll be the ones that address recalls with speed, dependability, and credibility because their systems are already aligned.

This is where zero-lag compliance becomes critical. Compliance can’t be something teams scramble to assemble after a problem surfaces. It has to exist continuously—embedded in day-to-day design, development, and change processes. When compliance data, traceability, and evidence are always current, organizations can move decisively under pressure, respond with confidence, and demonstrate control rather than intent.

In my mind, that’s not just compliance. It’s strategy.

Recalls will keep coming. The question is whether your organization meets them with panic or with systems built for reality.