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.
Well Care Compounding Pharmacy is recalling 869 units of Hydrogen Peroxide 3% due to FDA inspection findings regarding sterility assurance.
Synthes (USA) Products LLC is recalling 19 units of 1.5 mm Rapid Resorbable Orbital Floor Plates due to potential expiration date discrepancies on outer packaging labels.
DePuy Synthes is voluntarily recalling Norian Drillable Inject 3 CC-Sterile because the internal pouch may be labeled with the incorrect powder volume, though the actual contents are correct.
Synthes (USA) Products LLC is recalling Norian Drillable Inject 10 CC-Sterile units because the internal rotary pouch may be labeled with the incorrect powder volume, though the actual contents are correct.
Philips Healthcare is recalling 160 DigitalDiagnost stationary X-ray systems because the detector may incorrectly signal readiness, resulting in failed image acquisition.
Stryker is recalling 21 FlowPort II Adapters because the arthroscope sits in the adapter 180 degrees in the wrong direction.
Alcon is voluntarily removing specific lots of CENTURION FMS packs due to a molding irregularity that may reduce vacuum in the aspiration line.
Ellipse A/S is recalling 25 Ellipse ND: YAG Laser applicators because they lack required instructions for calibration procedures and schedules.
Beckman Coulter is recalling Cholesterol OSR6x16 reagent because Dipyrone may cause erroneous, false low results in cholesterol assays.
Synthes (USA) Products LLC is recalling 14 units of 1.5 mm Rapid Resorbable Orbital Floor Plates because outer package expiration dates may exceed subcomponent dates.
Well Care Compounding Pharmacy is recalling 1-HCG 2000 IU/ML vials due to GMP violations that may affect sterility.
Beckman Coulter is recalling Lipase OSR6x30 reagent because Dipyrone may cause erroneous false low results in lipase assays.
Well Care Compounding Pharmacy is recalling Phenylephrine 0.5% vials because FDA inspections found violations that may affect sterility.
Well Care Compounding Pharmacy is recalling Atropine Sulfate 0.5% Ophthalmic Drops due to FDA inspection findings of GMP violations that may impact sterility.
Pharmedium Services is recalling 240 bags of Potassium Chloride Injection due to a labeling error where Potassium Phosphate was printed on the label stock.
Well Care Compounding Pharmacy is recalling TRI-MIX # 6 vials because FDA inspections found violations that may affect product sterility.
Synthes (USA) Products LLC is recalling 22 units of 1.5 mm Rapid Resorbable Orbital Floor Plates because outer package expiration dates may exceed subcomponent dates.
Bayer Health Care LLC is recalling 37,512 bottles of Coppertone Sunscreen Lotion, Clearly Sheer, Broad Spectrum SPF 50, because the product contains undeclared Oxybenzone.
Well Care Compounding Pharmacy is recalling 869 vials of Methylcobalamin 12.5mg/mL due to FDA inspection findings of GMP violations that may impact sterility.
Greiner Bio-One is recalling 4 ml FX Sodium Fluoride/Potassium Oxalate tubes because they may contain low or no additives, potentially affecting glucose and lactate test results.
Beckman Coulter is recalling Lactate OSR6x93 reagent because Dipyrone may cause erroneous false low results.
Philips Healthcare is recalling five DuraDiagnost stationary X-ray systems because the detector may incorrectly signal readiness, causing failed image acquisitions.
Philips Healthcare is recalling Ingenuity Elite CT systems due to software defects that cause incorrect scan lengths and dose calculations.
Gulf Stream is recalling 2016-2017 Ameri-Lite and Super-Lite trailers because the Federal Certification label lists incorrect tire and wheel sizes, which could lead to installing the wrong replacement parts.
Philips is recalling 300 Ingenuity Core CT systems because they may fail to map the Varian drive after a user logs out and back in.