Case Study: Rapid recall execution in the medical device sector

In today’s regulatory climate, medical device manufacturers must operate with a heightened state of readiness. The post-pandemic era has reshaped expectations across the board—regulators are more assertive, consumers more vocal, and the margin for error increasingly narrow. When a product is designed for life-critical use, the stakes are amplified. Regulators can, and often do demand immediate corrective action, leaving manufacturers with little time to prepare and no room for missteps.

Medical device recalls have evolved into high-stakes interventions that test a company’s operational agility, regulatory fluency, and brand resilience. These events unfold under intense scrutiny from patients, caregivers, healthcare providers, and the media. Success is no longer defined by containment alone—it requires a recall infrastructure that can scale instantly, communicate transparently, and deliver verifiable outcomes that restore trust and ensure compliance.

When a leading medical device manufacturer faced an urgent recall mandate from the U.S. Food and Drug Administration (FDA), Sedgwick Brand Protection delivered a rapid-response program that transformed regulatory urgency into strategic execution—preserving patient safety, brand equity, and operational continuity.

Challenge

A defect was identified in a widely distributed medical device, prompting the manufacturer to notify the FDA. Given the potential risk to patient safety, the FDA requested that the recall be announced immediately, before the company had finalized its remedy strategy.

This triggered a cascade of operational challenges:

• Unprepared infrastructure: The manufacturer had not yet determined how to administer the remedy, leaving critical gaps in execution planning and consumer communication.
• Contact center overload: An initial team of 50 agents was quickly overwhelmed by a surge of calls from concerned patients, caregivers, and healthcare professionals. Hold times exceeded one hour, and agents were forced to collect contact details for follow-up, fueling frustration and triggering negative sentiment across social media platforms.
• Retail and pharmacy coordination: The company needed to rapidly engage thousands of pharmacies, clinics, and hospitals to support product replacement and consumer outreach, without disrupting ongoing operations or compromising regulatory obligations.

With no time to build internal capacity, the manufacturer turned to Sedgwick Brand Protection to lead the initial response and scale operations immediately.

The Solution

Sedgwick deployed a comprehensive, end-to-end recall solution designed to absorb the surge, restore consumer confidence, and meet regulatory expectations, all within days. The program was built on strategic coordination, scalable infrastructure, and empathetic engagement.

Key elements of the solution included:

• Rapid contact center expansion: Sedgwick scaled the contact center from 50 to 400 trained agents within 48 hours. Agents were equipped to triage inquiries, provide guidance, and manage voucher distribution for replacement products, reducing handoffs and resolving issues on first contact.
• Dedicated voucher processing application: A custom-built application streamlined voucher intake and shortened training time for new agents. This accelerated readiness and reduced friction for both consumers and support teams.
• Retailer notification and coordination: Sedgwick reached out to direct account holders and distributed 70,000 notifications via direct mail to pharmacies, clinics, and hospitals. These retailers then contacted affected consumers, triggering a second wave of inbound calls and expanding the reach of the recall.
• Return kit fulfillment and secure disposition: Even as many consumers discarded the affected product after receiving replacements, Sedgwick sent return kits to facilitate compliant returns. Returned units were quarantined and stored in secure facilities, preventing re-entry into the market and ensuring traceability.

This integrated approach ensured that patients received timely support, regulators were kept informed, and the brand remained protected throughout the crisis.

Results

Sedgwick’s rapid deployment and strategic coordination delivered measurable results:

• Call center stabilization: By day four, average hold times dropped from over an hour to just a few minutes. Agents resumed outbound follow-up to consumers who had previously called, closing the loop and restoring confidence.
• Streamlined product replacement: Consumers were able to quickly obtain replacement products from local pharmacies, minimizing disruption and reinforcing trust in the brand.
• Secure product recovery: Returned devices were processed, quarantined, and stored securely, ensuring regulatory compliance and eliminating residual market risk.
• Regulatory alignment: Sedgwick’s documentation and traceability protocols supported FDA oversight and positioned the manufacturer for successful audit outcomes.

Key Takeaways

• Prepare for regulatory urgency: Regulators may require immediate recall announcements. A proactive recall management plan ensures companies are not caught off guard.
• Prioritize patient communication: In life-critical recalls, consumers expect fast, clear, and empathetic communication. Direct outreach and actionable next steps build trust and loyalty.
• Scale with expert support: A recall partner with deep expertise and scalable infrastructure can absorb surges, manage complexity, and protect brand equity under pressure.
• Enable retailer-led outreach: Coordinating with pharmacies and clinics accelerates consumer engagement and supports rapid product replacement.
• Secure the supply chain: Compliant return kits and secure disposition protocols prevent affected products from re-entering circulation and reinforce regulatory confidence.

About Sedgwick Brand Protection

Brand and reputation are the most valuable and vulnerable assets a business has. Brands embody everything a business does, and its customers expect. 

Nothing says more about a company’s commitment to its customers than its efforts to uphold promises of safety, quality, and service. That’s why companies are often remembered more for how they handle an in-market challenge than for the problem itself. We know what it takes to manage recalls in a way that upholds your commitments to customers, supply chain partners, and regulators. 

Trusted by the world’s leading brands and businesses, Sedgwick Brand Protection works in partnership to manage the risks and minimize the impacts of in-market business and product crises. Since 1995, we have managed more than 7,000 of the most sensitive and time-critical product recall and remediation programs, spanning 150+ countries and 50+ languages. 

To discover more about our product recall and incident response solutions, visit: https://www.sedgwick.com/product-recall

400

agent contact center live in 48 hours

70K

notifications deployed

Call wait times

reduced

from over 60 minutes to just a few minutes by day four

Bespoke

voucher processing solution created