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.
Barlean's LLC is recalling Omega Man softgels due to undeclared sulfites. Sulfite levels do not exceed 10 ppm.
Compass Health Brands is recalling MediPress pneumatic compression systems because a design change lacked proper FDA premarket clearance.
Barlean's is recalling Essential Woman softgels due to undeclared sulfites. Sulfite levels in the finished goods do not exceed 10 ppm.
Back Roads Food Company is recalling specific lots of Coconut Ginger Granola because the product may contain pieces of aluminum.
Unipharma is recalling CVS Health Children's Pain & Fever Acetaminophen single-use vials due to a precautionary measure regarding potential contamination with B. cepacia bacteria.
Back Roads Food Company is recalling specific lots of Coconut Crunch Granola because the products may contain pieces of aluminum.
Unipharma is recalling CVS Health Children's Allergy Relief Liquid Medication due to a precautionary measure regarding potential contamination with B. cepacia bacteria.
Healthy Life Snacks is recalling Tropical Trail Mix because it contains undeclared sulfur dioxide. The product was distributed in Massachusetts and Rhode Island.
Unipharma is recalling DrKids Children's Cough & Chest Congestion DM due to potential contamination with B. cepacia bacteria.
Barlean's is recalling specific flax oil softgel supplements due to undeclared sulfites. The FDA classifies this as a Class III recall.
Schreiber Foods is recalling specific brands of Colby and Monterey Jack cheese due to the presence of hard plastic foreign material.
Siemens Healthcare Diagnostics is recalling 366 Atellica IM 1600 Analyzers due to multiple issues identified in the system software that required an update.
Le Cafe de la Plage is recalling 320 pints of Malibu Black Vanilla ice cream in California due to two complaints of plastic pieces in the product.
Ortho-Clinical Diagnostics is recalling 45 VITROS ECi/ECiQ Immunodiagnostic Systems worldwide due to a luminometer malfunction that may prevent the processing of MicroWell assays.
Ortho-Clinical Diagnostics is recalling 28 VITROS 3600 Immunoassay Systems because a luminometer malfunction may prevent the processing of MicroWell assays.
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a luminometer malfunction that may prevent the processing of MicroWell assays.
Ortho-Clinical Diagnostics is recalling 25 refurbished VITROS ECi Immunodiagnostic Systems because a luminometer malfunction may prevent the processing of MicroWell assays.
Island Desserts LLC is recalling 810 Key Lime and Cream Tortes because they contain undeclared FD&C Colors Yellow #5 and Blue #1.
Medica Corporation is recalling Wash1 solution because it fails to clean the probe effectively, potentially causing test interference on the EasyRA analyzer.
Cardinal Health is recalling ChemoPlus chemotherapy spill kits because the safety goggles inside contain natural rubber latex, despite the kit label stating the product is latex-free.
Schreiber Foods is recalling Great Value Fiesta Blend Cheese because it may contain hard plastic. The product was distributed to grocery stores in 30 states.
Siemens Healthcare Diagnostics is recalling 474 Atellica Sample Handler Prime units due to multiple issues identified in the system software that required an update.
Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunoassay System software versions 3.3.2 and below due to a luminometer malfunction that may prevent the processing of MicroWell assays.
Siemens is recalling 257 Cios Alpha mobile X-ray systems because continuous high-output use may cause premature failure of radiation components.
Wegmans is recalling Cilantro Lime Green Sauce in 8 oz and 0.5 gallon containers due to potential foreign material contamination.