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.
Hill Dermaceuticals is recalling Dermotic ear drops because the active ingredient was found to be subpotent during routine testing.
Hill Dermaceuticals is recalling 7,676 bottles of Fluocinolone Acetonide 0.01% Topical Oil because the active ingredient was found to be subpotent during routine testing.
Hill Dermaceuticals is recalling 8,734 bottles of Derma-Smoothe/FS topical oil because the active ingredient was found to be subpotent during routine testing.
AMS Diagnostics is recalling 167 BUN Urea Nitrogen kits because they were marketed outside FDA 510(k) requirements.
Hill Dermaceuticals is recalling 8,734 bottles of Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil because the active ingredient was found to be subpotent during routine testing.
Mars Food US is voluntarily recalling Uncle Ben's Ready Rice because package punctures caused spoilage. Consumers should check for damaged packaging.
Remel Inc is recalling Oxoid Vancomycin 30 mcg susceptibility discs because some may lack the antibiotic, potentially affecting in-vitro testing results.
Noven Pharmaceuticals is recalling 187,860 Daytrana patches because the release liner may be difficult to remove. The defect affects the ability to apply the patch correctly.
Zimmer, Inc. is recalling 3,638 units of Natural-Knee N-K II Domed All-Poly Pat components due to discoloration caused by premature oxidation.
Zimmer, Inc. is recalling 3,638 units of MOST Options System hinged tibia inserts because free radical oxidation caused discoloration. The issue resulted from improper storage conditions prior to packaging.
China Daheng Group Inc. is recalling 238 Denlase and Penlase dental laser systems because the user manuals lacked required calibration procedures.
Clarity Medical Systems is recalling 234 RetCam 3 halogen lamps that may fail early, potentially damaging internal electrical components.
Zimmer, Inc. is recalling 3,638 Natural-Knee II Poly Ultra Tibia components worldwide due to discoloration caused by premature oxidation during storage.
AtriCure is recalling 46 Reusable Clip Appliers because a customer reported a cracked spring in the handle. The devices were distributed nationwide.
Zimmer, Inc. is recalling 3,638 units of Natural-Knee II Constrained Knee System tibia components due to discoloration caused by premature oxidation.
Traxx International Corp is recalling Guaifenesin API powder because it may contain polyethylene fibers from a sifting screen.
Biomet, Inc. is recalling specific lots of the Intramedullary Bone Saw CAM Assembly because the Saw Blade Assembly was incorrectly identified as a CAM Assembly.
Zimmer, Inc. is recalling 3,638 Natural-Knee/Apollo knee implants because a component was discolored due to premature oxidation.
Paddock Laboratories is recalling seven lots of Perrigo Clindamycin Palmitate Hydrochloride for Oral Solution due to the presence of particulate matter.
Zimmer, Inc. is recalling specific Natural-Knee II unicompartmental knee system tibia components due to discoloration caused by premature oxidation during storage.
Biomet, Inc. is recalling specific lots of Intramedullary Bone Saw Cam Assemblies because they were incorrectly labeled as Saw Blade Assemblies.
Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.
Zimmer, Inc. is recalling 3,638 units of Natural-Knee II System components due to discoloration caused by premature oxidation. The affected devices were stored in transparent containers exposed to light.
RX South LLC is recalling 250 syringes of Hydroxyprogesterone Caproate 250mg/ml due to visible crystals formed by extreme cold during shipping.
Zimmer, Inc. is recalling 3,638 units of Natural-Knee II knee prostheses because a component was found to be discolored due to premature oxidation.