Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
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.
AdvoCare International is recalling specific lots of Muscle Strength Dietary Supplement because they contain undeclared milk, a major food allergen.
Integra LifeSciences is recalling 250 units of the TCC-EZ Total Contact Cast System because a quarantined lot may produce excessive heat.
Maharaja Food Importers is recalling frozen MMRF Neyyappam because the label lists ghee but fails to declare milk, a major allergen.
Maharaja Food Importers is recalling frozen MMRF Kumbiliappam because the label lists ghee but fails to declare milk as an ingredient.
Coastal Meds, LLC. is recalling 4,524 vials of Methylcobalamin Injectable due to the presence of unknown particulate matter.
Sofradim Production is recalling Versatex Monofilament Mesh due to patient reports of abdominal hernia recurrence following repair. The firm has updated instructions to warn surgeons about risks in specific procedures.
Stryker is recalling T5 Zipper Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Coastal Meds, LLC. is recalling 1,309 vials of LIPO-DEN Injectable-30 mL because of the presence of unknown particulate matter.
Izzy's Ice Cream is recalling Maple Nut ice cream in Minnesota due to possible undeclared peanut residue from walnuts.
Winnebago is recalling 293 recreational vehicles because roof racks may detach due to incorrect fasteners, creating a road hazard.
Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Stryker is recalling T5 Zipper Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires due to potential failure of the sterile packaging seal.
Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires due to a potential failure of the sterile packaging seal.
FDA is recalling EEA Hemorrhoid and Prolapse Stapler Sets due to a potential welding defect that could cause bleeding or anastomotic leak.
Zimmer Biomet is recalling 19,483 M/DN Intramedullary Fixation Humeral Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.
Fuel Injection Technology is recalling Summit Racing Max 500-EFI systems because fuel injector O-rings may leak, increasing fire risk.
Maharaja Food Importers is recalling ELA ADA (Jack Fruit) because the label lists ghee but fails to declare milk, a major allergen.
BioFire Diagnostics is recalling the FilmArray BCID Panel because it may produce false positive Proteus results when used with specific BD BACTEC blood culture bottles.
Synthes, Inc. is recalling 31 Stem Extractor f/Guide Bar units because the connection screw may break during use.
Maharaja Food Importers is recalling frozen Parotta products because the label lists ghee but fails to declare milk, a major allergen.
Stryker is recalling T4 Zipper Toga sterile garments because material layers may separate, creating a risk of exposure to contaminants.
Covidien LLC is recalling EEA Hemorrhoid and Prolapse Stapler Sets because a defective staple guide may cause bleeding or anastomotic leak during surgery.
Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, creating a risk of exposure to contaminants.
AdvoCare International is recalling 48,176 units of Nighttime Recovery Amino Acid and Herbal Dietary Supplement because the product contains undeclared milk, a major food allergen.