Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
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.
LumiQuick Diagnostics is recalling all lots of its Rotavirus Test Card because they were shipped to US locations without approved FDA clearance.
LumiQuick Diagnostics is recalling Methamphetamine Test Cards because they were shipped to locations without required FDA clearance.
LumiQuick Diagnostics Inc. is recalling all lots of Tramadol Strips (Catalog 74003) because they were shipped to US locations without approved FDA applications or clearance.
LumiQuick Diagnostics is recalling Methylphenidate Test Cards because they were shipped to locations without required FDA regulatory clearance.
LumiQuick Diagnostics is recalling Rickettsia IgG/IgM Test Cards because they were shipped to locations without required FDA clearance.
LumiQuick Diagnostics Inc. is recalling EDDP Strips because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling Cocaine Test Cards because they were shipped to US locations without required FDA clearance.
Smiley National is voluntarily recalling specific Kratom products because they contain unapproved dietary ingredients.
LumiQuick Diagnostics is recalling Malaria pf Antigen Test Cards because they were shipped to locations without approved FDA applications or clearance.
LumiQuick Diagnostics is recalling all lots of its Dengue IgG/IgM tests because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling K2 Test Strips because they were shipped to locations without FDA clearance.
LumiQuick Diagnostics Inc. is recalling Fentanyl Test Cards because they were shipped to US locations without approved FDA applications.
LumiQuick Diagnostics is recalling Morphine Test Cards because they were shipped to locations without required FDA approvals.
LumiQuick Diagnostics is recalling Myoglobin Test Cards because they were shipped to locations without FDA clearance.
LumiQuick Diagnostics Inc. is recalling H. Pylori Antibody Test Cards because they were shipped to locations without required FDA regulatory clearances.
LumiQuick Diagnostics is recalling Cardiac Panel Test Cards because they were shipped to locations without approved regulatory clearance.
LumiQuick Diagnostics Inc. is recalling Morphine Test Cards because they were shipped to US locations without required FDA approvals.
Nature's Value Inc. is recalling Vitacost brand L-Citrulline Amino Acid 750 mg capsules because the bulk ingredient contained an unidentified compound.
Evolution Fresh is recalling Organic Sweet Greens and Ginger Juice out of an abundance of caution.
LumiQuick Diagnostics Inc. is recalling Adeno/Rota Combo Test Cards because they were shipped to US locations without required FDA regulatory approvals.
LumiQuick Diagnostics is recalling Oxycodone Test Cards because they were shipped to US locations without required FDA approvals.
LumiQuick Diagnostics Inc. is recalling all lots of THC Strip (Catalog 74035) because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling Barbiturate Strips shipped to US locations without approved PMA, IDE, or 510(k) clearance.
LumiQuick Diagnostics is recalling Syphilis Test Cards because they were shipped to locations without required FDA clearances.
LumiQuick Diagnostics is recalling H. Pylori Ab Test Cards because they were shipped to locations without approved FDA applications.