GKS Author featured in Sedgwick Recall Index

Q1 2025 U.S. Recall Index: What Changed and Why It Matters

Author: George Kwiecinski

A concise briefing for quality, regulatory, and product leaders on Sedgwick’s latest recall data and how to prepare.

Key Takeaways (U.S.)

• Recalled units jumped 25% in Q1 2025 even as total recall events dipped slightly to 775 (from 780 in Q4’24). Source: Sedgwick press release; coverage summary.

• Sedgwick PR and other Coverage

Why this matters: Severity and complexity are diverging from raw event counts. Volumes are rising in select sectors while total events plateau — implying larger batch sizes, systemic quality issues, or late discovery amplifying scope.

Read the Report Here

What GKSC Is Watching (for Clients)

1. FDA/USDA enforcement mix: Expect more targeted, higher‑impact events despite stable event counts. Tighten detection-to-notification SLAs and ensure traceability data completeness.
2. Software-driven risk: SW/FW defects remain top drivers in regulated sectors. Pre‑stage PCCPs and post-market signal monitoring for connected devices.
3. Recall readiness drills: Run mock recalls quarterly; verify consumer comms channels (IVR, SMS, web) and supplier backhaul logistics capacity.

Practical Checklist for Firms and SMEs

• Inventory & UDI coverage: Confirm lot/serial mapping and downstream partner visibility.
• Crisis comms templates: Pre‑approved scripts for FDA, CPSC, NHTSA, and consumer notices.
• Regulatory playbooks: QMSR alignment; LDT/IVD oversight impact; AI/ML PCCP change control.
• Data room: Centralize CAPA, field-failure rates, and complaint trending; enable T+0 data export.
• Mock recall: Validate decision trees, escalation paths, and reverse‑logistics partners.

How do you prepare for product risk? Start with signal detection, traceability, and consumer communication. Q1 2025 shows unit volumes rising while event counts hold steady — meaning complexity is up. Read Sedgwick’s latest Recall Index and pressure‑test your plan this week.

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Notes & Sources

• Sedgwick landing page (Edition 1, 2025)
• Sedgwick PR (May 15, 2025)
• Third‑party coverage
• Medical device special edition (Mar 2025)