# GKS Author featured in Sedgwick Recall Index Source: https://www.globalkeysolutions.net/media/gks-author-sedgwick-recall-index Type: blog Published: April 30, 2025 Updated: March 12, 2026 Authors: George Kwiecinski, Stuti Neelam --- # Q1 2025 U.S. Recall Index: What Changed and Why It Matters **Author:** [George Kwiecinski](https://www.linkedin.com/in/kwiecinskigeorge/) > 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. ![image.png](https://storage.googleapis.com/gks-blog-images/blog-images/879890d37575470dacaa2ceb0e85c248.png) - [Sedgwick PR](https://www.sedgwick.com/press-release/number-of-recalled-products-in-the-us-rose-in-q1-2025/) and other [Coverage](https://www.claimsjournal.com/news/national/2025/05/16/330637.htm) > **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](https://marketing.sedgwick.com/acton/media/4952/us-recall-index ) --- ## 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. [Find this post here](https://www.linkedin.com/posts/kwiecinskigeorge_how-do-you-prepare-for-product-risk-i-activity-7333984779974959104-334F) --- ## Notes & Sources - [Sedgwick landing page (Edition 1, 2025)](https://marketing.sedgwick.com/acton/media/4952/us-recall-index) - [Sedgwick PR (May 15, 2025)](https://www.sedgwick.com/press-release/number-of-recalled-products-in-the-us-rose-in-q1-2025/) - [Third‑party coverage](https://www.claimsjournal.com/news/national/2025/05/16/330637.htm) - [Medical device special edition (Mar 2025)](https://www.advamed.org/member-center/resource-library/state-of-the-nation-2025-global-medical-device-recall-index-report/) ---