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.
Oridion Medical is recalling 144 CAPNOSTREAM 20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Church & Dwight is recalling Trader Darwin's Chewable Peppermint Flavored Melatonin because bottles contain GABA Calm Sublingual Orange tablets instead.
Oridion Medical is recalling eight refurbished Capnostream20 monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling 2,806 Capnostream 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Radiometer America Inc. is recalling ABL90 FLEX analyzers with software version 3.3MR1 or below because they may aspirate calibration solution instead of rinse solution.
Oridion Medical is recalling 22 refurbished Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Ortho Clinical Diagnostics is recalling VITROS TSH Reagent Packs because biotin supplements may cause biased test results at lower concentrations than stated in the instructions.
Oridion Medical is recalling six refurbished Capnostream20 patient monitors because alarm and time settings may reset to factory defaults when powered off.
Oridion Medical is recalling 11 refurbished Capnostream20 bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling 23 Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling 16 CapnoStream 20P patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Ortho Clinical Diagnostics is recalling VITROS Folate Reagent Packs because biotin supplements may cause biased test results at lower concentrations than stated.
Exactech is recalling Equinoxe Reverse Drill Bit Kits because they may contain two 2mm drill bits instead of the intended 2mm and 3.2mm combination.
Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal patches because the adhesive delivery system failed to meet specification standards for shear.
Hetero Labs Limited is recalling 98,016 bottles of Montelukast Sodium 10 mg tablets because a pharmacist reported blue specks on the tablets.
Confidence Inc. is recalling Bone-Lock dietary supplements containing undeclared ingredients, including Hydroxypropyl Methylcellulose, Titanium Dioxide, and Polyethylene Glycol.
Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal patches because the adhesive delivery system failed to meet specification standards for shear.
Hetero Labs is recalling Fenofibrate 145 mg tablets because a foreign Valacyclovir 500 mg tablet was found in the bottles.
Pin Hsiao & Associates, LLC dba Zen Bakery is recalling Trader Joe's Cinnamon Coffee Cake because it contains undeclared soy lecithin.
Zimmer Biomet is recalling a specific lot of 8.3mm tibial nails that are actually 12mm. The product was distributed only in the Netherlands.
Zimmer Biomet is recalling 16 Vanguard 360 Revision Knee System tibial block augments because the sterile packages contained one bolt instead of the required two.
Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal patches because the adhesive delivery system failed to meet specification standards for shear.
Tosoh Bioscience Inc is recalling eight G8 Automated HPLC Analyzers because they were distributed with software that lacks a 510(k).
Baxter Healthcare is recalling 523,896 bags of Levofloxacin Injection in 5% Dextrose because the drug concentration was higher than specified.
Zimmer Biomet is recalling 16 Vanguard 360 Revision Knee System tibial block augments because the sterile packages contained only one bolt instead of the required two.