Recall Management

In the medical device industry, recalls and rework are virtually inevitable. Even with strong quality systems in place, the complexity of devices, supply chains, and regulatory environments means issues can—and do—arise.

At EnPak, we help MedTech companies navigate these critical moments with confidence. Whether you’re managing a recall, packaging deviation, or quality hold, we provide immediate support. In addition, our team delivers operational and compliance expertise tailored to your situation. Moreover, we offer this support without requiring minimum volume commitments, ensuring flexibility when you need it most.

We are FDA-registered and ISO 13485:2016 certified. Our Quality Management System complies with FDA 21 CFR Part 820, ensuring every action meets the highest standards of documentation, traceability, and compliance.

Recall Management
From retrieval and quarantine to documentation and regulatory support, we manage correction and removal logistics efficiently. As a result, your internal teams can focus on root cause analysis and resolution. Furthermore, we ensure full traceability at every step and execute each action quickly to minimize disruption and maintain compliance.

Repackaging & Inspection
We inspect, sort, and repackage non-sterile devices into compliant packaging formats. Our processes meet FDA and international standards—getting your inventory back into circulation efficiently and safely.

Rework & Relabeling
For nonconforming or held products, we offer rework solutions including over-labeling, relabeling, and thorough inspection. As a result, we help bring products back into compliance while preserving product integrity and ensuring documentation accuracy.

Medical Device Scrap Disposal
When product disposition is required, we manage secure scrap disposal through disassembly, certified destruction, and detailed records—protecting both your compliance standing and your brand.

Flexible, Scalable Support
Whether you’re addressing a targeted field correction or a large-scale recall, our services scale to meet your needs. We become an extension of your team—helping reduce turnaround time, minimize disruption, and maintain regulatory confidence.

EnPak delivers calm, capable support during high-stakes situations. Our structured approach and responsiveness with medical device recall management helps keep your business moving—even when the unexpected happens. Read our Quality Commitment.