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.
Jody's Inc. is recalling Freedom Funfetti candy because it contains undeclared food dyes Blue #1, Blue #2, and Red #40.
Jody's Inc. is recalling 144 bags of Breast Cancer Awareness Kettle Corn due to the presence of undeclared Red #3 dye.
Ansar Group is recalling 351 ANX-3.0 Autonomic Monitor systems because the blood pressure circuit may fail to inflate the cuff or activate, resulting in no blood pressure measurement.
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.
Intelerad Medical Systems is recalling IntelePACS software versions 3-8-1 to 4-9-1 because partially truncated files may be incorrectly reported as complete.
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.
Childrens Medical Ventures is recalling Gel-E Donut and Squishon 2 gel pillows because of visible mold. The mold was identified as Cladosporium and Penicillium fungi.
Biomet is recalling 461 Vanguard 360 Femoral Boss Reamers because they were manufactured oversized and may not fit into mating components.
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units may be labeled with the incorrect diopter power.
Zimmer, Inc. is recalling 6.5 mm Cancellous Screws that failed leak tests due to inner cavity damage. The recall covers 47,682 units distributed nationally and internationally.
AMO Puerto Rico Manufacturing is recalling 77,055 intraocular lenses that may be labeled with the incorrect diopter power.
Gyrus Medical is recalling 507 units of the ACMI Falope-Ring Dilator because the non-sterile component was sold as a stand-alone item.
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units may be labeled with the incorrect diopter power.
Biolase Technology Inc is recalling 117 WaterLase iPlus Dental Laser Systems because a software error may cause the air setting to change to 1% and OFF during procedures.
AMO Puerto Rico Manufacturing is recalling 77,055 Tecnis CL intraocular lenses because units may be labeled with the incorrect diopter power.
US Compounding Inc is recalling 762 syringes of ephedrine sulfate injection due to a labeling error on the outer protective bags that could cause confusion regarding the drug's strength.
AMO Puerto Rico Manufacturing is recalling 77,055 Tecnis CL intraocular lenses because units may be labeled with the incorrect diopter power.
Zimmer, Inc. is recalling 47,682 units of 6.5 mm Cancellous Screws because they failed a leak test due to damage of the inner cavity.
Zimmer, Inc. is recalling 47,682 units of Magna-Fx Cannulated Bone Screws because they failed leak tests due to inner cavity damage.
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.
AMO Puerto Rico Manufacturing is recalling 77,055 Tecnis CL intraocular lenses because units may be labeled with the incorrect diopter power.
AMO Puerto Rico Manufacturing is recalling 77,055 Tecnis CL intraocular lenses because they may be labeled with the incorrect diopter power.
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units may be labeled with the incorrect diopter power.