When patient safety and regulatory oversight converge, there is no margin for delay.
When facing a medical device safety event, manufacturers must act with disciplined speed and precision to protect patients, guide clinicians, maintain traceability and execute compliant corrective action – all while under heightened regulatory scrutiny.
Pace versus precision
A medical device recall compresses timelines while elevating expectations. Contact volumes can surge within hours as patients, caregivers and clinicians all seek clarity. Every response, inbound or outbound, becomes part of the regulatory record.
Delays undermine confidence. Inconsistent messaging creates clinical uncertainty. Documentation gaps invite increased oversight. A single product issue can quickly escalate into a broader question of governance if the response appears unstructured or unstable.
The challenge for manufacturers lies not only in acting quickly, but in executing with accuracy, consistency and control under intense operational and regulatory pressure.
How one global device manufacturer responded when an urgent mandate left no time to prepare
Within hours, a critical defect overwhelmed the manufacturer’s response capabilities.
When a leading manufacturer uncovered a defect in a widely distributed device, regulators required immediate public notification, before replacement models or remediation plans were ready.
Contact volumes instantly exceeded internal capacity. Patients, caregivers and clinicians sought urgent guidance, while pharmacies and clinics needed coordinated communication. Every interaction required compliant documentation, intensifying operational pressure. Recognizing the threat, the manufacturer engaged Sedgwick Recall to help stabilize execution, strengthen communication and restore control.
The solution
The priority was not merely to scale operations, but to re-establish disciplined, compliant processes that maintained control and confidence across every stakeholder interaction.
The program included:
- Rapid contact center expansion: Within 48 hours, Sedgwick scaled from 50 to 400 agents to triage inquiries, provide clear guidance and manage replacement vouchers.
- A comprehensive digital voucher platform: A custom-built application streamlined voucher allocation and device replacements, accelerating agent readiness and ensuring consistent, auditable case handling.
- Coordinated point‑of‑care engagement: Sedgwick alerted more than 70,000 pharmacies, clinics and hospitals, enabling direct outreach to affected consumers.
- Return kit fulfillment and secure disposition: Return kits enabled compliant device collection, while secure quarantine protected chain‑of‑custody and prevented affected devices from re‑entering circulation.
The results
Over the course of the recall, Sedgwick delivered measurable, business‑critical results:
- Restored call center performance: Within days, average hold times dropped from over an hour to minutes, reinforcing patient and clinician confidence.
- Accelerated product replacement: Streamlined distribution through local points of care ensured affected consumers received replacements quickly, reducing disruption and strengthening brand credibility.
- Ensured secure and compliant device recovery: Returned devices were quarantined, tracked and processed in full regulatory alignment, eliminating residual market risk and safeguarding chain-of-custody.
- Strengthened regulatory readiness and audit assurance: Comprehensive documentation, traceability, and reporting protocols supported regulatory oversight and positioned the manufacturer to demonstrate full compliance.
This is what effective recall surge support looks like when it is engineered for control, compliance and brand protection, not just volume absorption.
Protecting the medical device industry for 30+ years
As medical technologies become more connected, data‑driven and integrated into critical care pathways, manufacturers face a new era of product safety expectations.
Since 1995, Sedgwick has supported leading medical device companies through periods of heightened recall exposure — scaling patient and clinician engagement, strengthening regulatory compliance and safeguarding trust when it matters most.
Recall leadership, proven at scale:
- Global delivery at scale: 150+ countries and 50+ languages supported
- Depth of experience: 8,000+ recalls and remediation programs successfully managed
- Proven market impact: 500M+ products safely removed from the market worldwide
- Established heritage: 30+ years of disciplined, regulator-aligned recall leadership
A conversation, when it’s useful
Every recall is different, but the pressures manufacturers face are remarkably consistent.
If you are considering how your organization would manage customer engagement, claims handling, logistics and operational scale during a high-visibility product safety event, a short conversation can help clarify what readiness really looks like in practice.
Request a call or arrange an introductory discussion with Jeremy.
Jeremy Schutz
Director of Business Development
Jeremy leads strategic initiatives across product recall and market correction services, guiding global brands through complex incidents, crises, and evolving regulatory requirements. With more than a decade of experience, he partners with executive and operational teams to strengthen recall readiness, and navigate compliance challenges with clarity, discipline, and operational control across global markets
He works closely with stakeholders to align response strategies with regulatory expectations, ensuring coordinated execution and defensible outcomes under scrutiny.
He is a graduate of Indiana University and is widely recognized for his industry insight. He contributes to leading publications and speaks at major forums, sharing practical perspectives on recall risk mitigation, regulatory coordination, and engagement with the U.S. Consumer Product Safety Commission and the U.S. Food and Drug Administration.
Get deeper insights with our Recall Index
For more than a decade, Sedgwick’s Recall Index report has set the benchmark for product safety intelligence — combining rigorous data analysis with an unbiased perspective on the emerging trends shaping the medical device risk landscape.
The latest edition delivers a focused 2025 year-in-review, analyzing the structural, regulatory and economic forces influencing product safety exposure — and what this signals for manufacturers as they navigate the remainder of 2026.
Download your copy now and discover why the Recall Index is trusted by medical device safety and risk leaders in more than 100 countries.
