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.
Gasco Industrial is recalling NuChef Soy Sauce in Puerto Rico due to an undeclared wheat allergen.
Heartland Coca-Cola Bottling Company is recalling Mello Yola citrus-flavored soda cans because sharp edges on the cans could cut consumers' mouths.
Synthes (USA) Products LLC is recalling 21 sterile 2.5 mm Guide Rods due to potential package seal defects that may compromise sterility.
Ortho-Clinical Diagnostics is recalling 349 units of VITROS DAT Performance Verifier I because the storage labeling is incorrect, which may cause lower than expected test results.
Ion Beam Applications is recalling three Proteus 235 proton therapy systems in Florida due to potential energy range discrepancies in the first layer of irradiation plans.
Bausch & Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives nationwide due to an atypical volume of complaints regarding dull blades.
Medtronic is recalling unimplanted SynchroMed II Model 8637 pumps to address a design flaw that can cause motor stalls due to corrosion.
Philips is recalling 332 network firewalls used with IntelliVue systems due to a defective clock component that may cause loss of connection.
DePuy Orthopaedics is recalling 130 units of the Concorde Lift Driver Shaft AO due to a potential for intra-operative breakage of driver tips.
Heartland Coca-Cola Bottling Company is recalling Orange Fanta cans because sharp edges on the cans could cause cuts to consumers' mouths.
Bausch & Lomb Inc Irb is voluntarily recalling LASEREDGE Knives intended for ophthalmic surgery because of an atypical volume of complaints regarding dull blades.
Zimmer Biomet is recalling 457 Flexible Shaft instruments because they may not clean adequately, posing a risk of infection.
Heartland Coca-Cola Bottling Company is recalling Fresca Original Citrus Sparkling Flavored Soda cans because sharp edges were observed that could cause cuts to consumers' mouths.
Heartland Coca-Cola Bottling Company is recalling Strawberry Fanta cans because sharp edges were observed, posing a risk of cuts to consumers' mouths.
Roche Diagnostics is recalling 245 cobas 8000 c 502 modules to add a warning to the manual, preventing operator injury during maintenance.
Heartland Coca-Cola Bottling Company is recalling specific lots of Coca-Cola Zero Sugar cans due to sharp edges that could cause mouth cuts.
Heartland Coca-Cola Bottling Company is recalling Dr Pepper 12 oz cans because sharp edges were observed, posing a risk of cuts to consumers' mouths.
Radio Flyer is recalling about 5,000 eWagons because improper wiring can cause the motor to activate unintentionally, posing an injury hazard.
Whole Alternatives LLC is recalling dark chocolate covered almonds because the label failed to declare milk, posing an allergy risk.
Heartland Coca-Cola Bottling Company is recalling Caffeine Free Coke Zero cans because sharp edges were observed that could cause cuts to consumers' mouths.
Synthes (USA) Products LLC is recalling 2.5 mm Reaming Rods because package seal defects may have compromised sterility. The devices are used in orthopedic surgery.
Stryker is recalling specific lots of ACL Interface Screws because routine testing found bioburden levels higher than internal acceptable rates.
Heartland Coca-Cola Bottling Company is recalling Pibb Xtra soda cans because sharp edges were observed, posing a risk of cuts to consumers' mouths.
Philips is recalling 63 IQon Spectral CT systems due to software errors that may cause image misrepresentation or failure to generate images.
Medtronic is recalling BIO CAL Temperature Controllers because it cannot develop a cleaning protocol that meets current industry standards. Users are advised to discontinue use and dispose of the devices.