[pending] HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.
Pending LLM rewrite. Source: FDA_DEVICE Z-1839-2025.
- Product
- HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.
- Category
- Medical Device
- Distribution
- Distributed nationwide
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-1839-2025.
Pending LLM rewrite. Source: FDA_DEVICE Z-1836-2025.
Pending LLM rewrite. Source: FDA_DEVICE Z-1832-2025.
Pending LLM rewrite. Source: FDA_DEVICE Z-1850-2025.
Pending LLM rewrite. Source: FDA_DEVICE Z-1858-2025.
Pending LLM rewrite. Source: FDA_DEVICE Z-1884-2025.
Pending LLM rewrite. Source: FDA_DEVICE Z-1825-2025.
Pending LLM rewrite. Source: FDA_DEVICE Z-1880-2025.
Pending LLM rewrite. Source: FDA_DEVICE Z-1864-2025.
Pending LLM rewrite. Source: FDA_DEVICE Z-1859-2025.
Pending LLM rewrite. Source: FDA_DRUG D-0451-2025.
Pending LLM rewrite. Source: NHTSA 25V146000.
Pending LLM rewrite. Source: NHTSA 23V220000.
Pending LLM rewrite. Source: NHTSA 25V147000.
Pending LLM rewrite. Source: NHTSA 23V217000.
Pending LLM rewrite. Source: NHTSA 23V224000.
Pending LLM rewrite. Source: NHTSA 23V221000.
Pending LLM rewrite. Source: NHTSA 25V148000.
Pending LLM rewrite. Source: NHTSA 23V222000.
Pending LLM rewrite. Source: NHTSA 25V058000.
Pending LLM rewrite. Source: NHTSA 25V064000.
Pending LLM rewrite. Source: NHTSA 25V059000.
Pending LLM rewrite. Source: NHTSA 25V065000.
Pending LLM rewrite. Source: NHTSA 25V060000.
Pending LLM rewrite. Source: NHTSA 24V025000.