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.
Philips Medical Systems is recalling Ingenuity Core 128 CT systems due to software issues in version 4.1.6.
Philips Medical Systems is recalling Ingenuity Core CT systems due to software issues in Brilliance iCT 4.1.6.
The Binding Site Group is recalling Rheumatoid Factor kits because low and high controls are returning results above assigned values.
Angiodynamics, Inc. is recalling Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering desired microwave energy.
Busse Hospital Disposables is recalling Laceration Trays because they may contain loose polypropylene foreign matter above release specifications.
Medline Industries is recalling Skin Biopsy Packs because the iodine concentration is below the label claim.
Medline Industries is recalling sterile catheter insertion trays because the iodine concentration in the prep pads is below the labeled claim.
Medline Industries is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than labeled.
Zimmer Biomet is recalling 638 units of Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.
Tosoh Bioscience Inc is recalling AIA-900 9tray and 19tray Sorters due to a potential malfunction of the photo interrupter caused by aging.
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process caused set screws and sleeves to shift, potentially preventing proper assembly.
Johnson & Johnson is recalling specific lots of Neutrogena deep clean purifying whipped foam cleanser because the containers may leak propellant and product.
Medline Industries is recalling 40 cases of Sheath Removal Kits because the iodine concentration is below the labeled claim.
Jarrow Formulas is recalling one lot of Liquid L-Carnitine because a higher-than-normal micro result was found during testing.
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.
Exactech is recalling 30 Equinoxe shoulder implants because they may be mislabeled. The devices were distributed to facilities in 15 US states, Puerto Rico, and Switzerland.
Tosoh Bioscience Inc is recalling 565 AIA-900 Automated Enzyme Immunoassay Analyzers due to a potential malfunction of the photo interrupter caused by aging.
Premier Pharmacy Labs is recalling 193 vials of Mitomycin 40 mg/mL due to a label error on the declared strength.
Medline is recalling Incision Drainage Kits because the iodine content is below the labeled claim. The product was distributed nationwide and internationally.
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.
Medline Industries is recalling Suture Removal Trays because the iodine concentration in the prep pads is below the labeled claim of 0.85%.
Roche Diagnostics is recalling 255 Elecsys 2010 analyzers due to a software malfunction that may cause data mismatches in sample and control files.
Glenmark Pharmaceuticals is recalling Mometasone Furoate Cream due to market complaints about a gritty texture.