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.
Ariola Foods is recalling Seviroli brand Cannoli Shells in New York due to undeclared soy lecithin.
Draeger Medical Systems is recalling 2,760 Dual Hemo MCable Pods (Revisions 15 and 16) because they may allow liquid ingress, potentially causing incorrect invasive blood pressure readings.
Diagnostica Stago is recalling Neoplastine Cl Plus reagent vials because a defect may cause inaccurate prothrombin time test results.
Paige Common is recalling 46 packages of Maple Minis-Gluten Free Donut Bites sold in Oregon due to undeclared soy lecithin.
Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.
Zimmer Biomet is recalling 12 Humeral Stems because two lots were commingled and etched with incorrect lot numbers, creating a risk of using the wrong implant size.
Deerfield Imaging is recalling 15 IMRIS ORT100 tables because the rotational locking mechanisms can disengage, potentially causing unintended movement.
Kidde is recalling about 452,000 dual-sensor smoke alarms in the U.S. because a manufacturing defect may prevent them from detecting smoke.
Kodiak Cakes is recalling Energy Waffles, Blueberry Chia, because the product contains whey but fails to declare the major food allergen milk on the label.
Brainlab AG is recalling ExacTrac Patient Positioning System software versions 6.0 through 6.5 due to a risk of misinterpreting beam authorization when used with specific Varian accelerators.
New Seasons Market LLC is recalling 45 units of 9-inch Asparagus and Goat Cheese Quiche because egg is missing from the 'Contains' statement on the label.
Alden Optical is recalling HP54 Toric Daily Wear Soft contact lenses because they lack sterility assurance. Consumers should stop using the affected lenses.
Plant Devas Inc. is recalling Rose Face Care Kits because FDA testing found excessive and virulent microorganisms in the products.
Medtronic is voluntarily recalling one lot of MAHURKAR Elite Acute Dual Lumen Dialysis Catheters because they were distributed without being sterilized.
Baxter is recalling SIGMA Spectrum Infusion Pumps because excessive wear in the pumping mechanism may cause over- or under-infusion of fluids.
Zimmer Biomet is recalling specific hip and knee implants because LDPE packaging may leave residue on the polished surfaces.
Alden Optical is recalling 56 units of Alden HP49 Toric Daily Wear Soft contact lenses because they lack sterility assurance. The lenses were distributed in 25 US states and Canada.
Smiths Medical ASD Inc. is recalling 1,077 units of Power PORT-A-CATH II kits that may contain incorrect introducer sizes or locking collars.
Zimmer Biomet is recalling specific Versus hip prostheses because LDPE packaging may leave residue on the polished implant surface.
Stanbio Laboratory is recalling RaPET RF Latex Reagent because it causes all patient serum samples to yield weakly positive test results.
Zimmer Biomet is recalling 429 units of nondegradable soft tissue fixation fasteners because the implant shaft may shift and fall out during device opening.
Plant Devas Inc. is recalling the Blue Face Care Kit because FDA testing found excessive and virulent microorganisms in the product.
ZOLL Medical is recalling specific adult defibrillator electrodes that may cause R Series devices to deliver pediatric energy levels instead of adult levels.
Paige Common is recalling Almond Love Bar vegan chocolate bars due to undeclared soy lecithin. The product was distributed in Oregon.
Diagnostica Stago is recalling 1,636 Neoplastine Cl Plus kits due to a defect causing inaccurate prothrombin time test results.