Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Pending LLM rewrite. Source: FDA_DEVICE Z-0491-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0442-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0464-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0446-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0496-2026.
Pending LLM rewrite. Source: FDA_FOOD H-0181-2026.
Pending LLM rewrite. Source: FDA_FOOD H-0172-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0478-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0490-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0481-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0474-2026.
Pending LLM rewrite. Source: FDA_FOOD H-0175-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0458-2026.
Pending LLM rewrite. Source: FDA_FOOD H-0185-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0445-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0479-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0494-2026.
Pending LLM rewrite. Source: FDA_FOOD H-0191-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0452-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0482-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0450-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0501-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0449-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0434-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0476-2026.