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Recall vs. safety notice

A recall is a formal correction or removal action under FDA's regulatory framework; a "safety notice" is often just how a company chooses to communicate about it — not a distinct regulatory category.

21 CFR Part 806; 21 CFR 7.3(m)
What people get wrong

Companies sometimes use softer language like "safety notice" or "field advisory" in customer-facing communication for what is, underneath, a Class II or Class III recall reportable under 21 CFR Part 806. The public-facing label doesn't change the underlying regulatory obligation — FDA classifies the recall by health-risk severity regardless of what a press release calls it, and MAUDE/recall databases will reflect the real classification either way.

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