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.
At Home Procurement is recalling approximately 990 Tie Dye Fur Toy Trunk Storage Chests sold from September 2023 through February 2024 because they lack a lid support feature and ventilation holes, creating entrapment and suffocation hazards.
REI is recalling Co-op Cycles REV children's bicycles (12-, 16-, and 20-inch models, 2022-2024) because the training wheel assembly knob can loosen and detach, creating fall and injury hazards.
Consumer Product Partners is recalling Pure Petroleum white petrolatum products sold at Rite Aid, Kroger, Harris Teeter, and CVS nationwide because the products labeled as pure white petrolatum actually contain undisclosed lavender and chamomile.
Clasen Quality Chocolate Inc. is recalling Milk Chocolate Flavored Confectionery Coating (Item #58710) due to potential Salmonella contamination. The bulk tanker product was distributed across nine states.
Clasen Quality Chocolate Inc. is recalling Milk Chocolate Flavored Confectionery Coating Bulk (Item #60692) due to potential Salmonella contamination. The product was distributed across nine U.S. states.
Clasen Quality Chocolate Inc. is recalling Milk Chocolate Crunch Bulk OTBD for potential Salmonella contamination. The product was distributed across nine U.S. states.
Howmedica Osteonics Corp. is recalling HRIS Storage & Sterilization Cases (Part 6210-9-900) due to a design flaw that may allow reuse and resterilization of single-use, sterile instruments. This poses a contamination and infection risk.
Heinen's Tuscan Salad Bowl is recalled due to the presence of undeclared pecans, a known allergen not listed on the label. Consumers with pecan allergies face a risk of allergic reaction.
Clasen Quality Chocolate Inc. is recalling Snow White Chocolate bulk tanker product due to potential Salmonella contamination. The product was distributed across multiple states.
OSSOS-SANS Reforzado tablets are being recalled because they contain undeclared active pharmaceutical ingredients—diclofenac and methocarbamol—and were marketed without FDA approval.
Eugia US LLC recalls 70,125 vials of Dexamethasone Sodium Phosphate injection due to failed impurity specifications. Testing found sulfonic acid adduct of dexamethasone phosphate exceeded allowed limits.
Ethicon recalls PDS Plus Antibacterial sutures due to packaging defects that compromised sterility. The affected units may cause infection if used in surgery.
Clasen Quality Chocolate is recalling 18,800 lbs of milk chocolate confectionery drops due to potential Salmonella contamination. The product was distributed across nine states.
Ethicon recalls 306,000 MONOCRYL surgical sutures worldwide due to holes in primary packaging from a manufacturing defect that compromises sterility and could result in infection.
Denison Pharmaceuticals recalls 113,544 bottles of Little Remedies Gas Relief Drops (Lot #0855, exp. 8/31/2025) due to manufacturing deviations. All units have been recovered and controlled at the manufacturer.
Beaver Visitec International is recalling 126 Xstar Safety Slit Knives with incorrect blade configuration. The recalled knives have the bevel oriented to the back instead of the front.
Clasen Quality Chocolate Inc. is recalling 74,050 pounds of White Chocolate Wafer due to potential Salmonella contamination. The product was distributed to food service and ingredient suppliers across nine states.
Clasen Quality Chocolate Inc. is recalling 4M Caramel Flavored Confectionery Drop due to potential Salmonella contamination. The product was distributed to nine states.
Exactech is recalling OPTETRAK Advanced Patella knee implant components packaged in vacuum bags that did not meet manufacturing specifications. Improper packaging could compromise product sterility.
Breckenridge Pharmaceutical recalls Duloxetine 60mg capsules nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA interim limits. Affected lots had current good manufacturing practice (CGMP) deviations.
Ethicon recalls 341,532 units of VICRYL surgical sutures worldwide due to holes in primary packaging that compromise sterility and could result in infection.
Ethicon is recalling 56,952 units of PDS II polydioxanone sutures distributed worldwide because a packaging defect resulted in compromised sterility, which could lead to infection. No illnesses have been reported.
Lupin Pharmaceuticals is recalling one lot of Cefixime oral suspension (200 mg/5 mL) due to failed content uniformity specifications. The recall affects 3,552 bottles distributed nationwide.
Exactech is recalling OPTETRAK Three Peg Patella knee components packaged in out-of-specification vacuum bags. The affected products were distributed worldwide.
Clasen Quality Chocolate Inc. is recalling Milk Chocolate Flavored IC Coating distributed in nine states due to potential Salmonella contamination. The product is sold in bulk tanker format for use in food manufacturing.