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.
Boston Scientific is recalling 458 Contour VL Variable Length Ureteral Stents because trace amounts of nickel particles were found on the devices.
Medtronic is recalling Ares Antibiotic-Impregnated Catheters due to a potential seal defect that may compromise sterility and increase the risk of post-operative infection.
HS Baking Enterprises is recalling specific lots of Darlington's Soft Baked Cookies because an ingredient contained a milk derivative that was not declared on the label.
Merit Medical Systems is recalling 90 custom angiography kits because header bags may not be fully sealed, potentially compromising the sterile barrier and leading to infection.
Medtronic is recalling 1,926 Ares Antibiotic-Impregnated Catheters due to a potential seal defect that may compromise sterility and increase infection risk.
Westmed is recalling 16,000 adult elongated oxygen masks because the tube connection may become loose, potentially delaying oxygen therapy.
Becton Dickinson is recalling the BD Phoenix PMIC/ID-105 in vitro diagnostic device because it may produce false resistant results for S. aureus, potentially affecting antibiotic treatment.
Westmed is recalling 1,200 units of Adult CO2/O2 Masks because the oxygen delivery tube may become loose, potentially delaying treatment.
Rust-Oleum is recalling about 10,500 cans of Professional Bright Galvanizing Compound Spray because the bottom of the pressurized container can detach unexpectedly, posing an injury hazard.
Becton Dickinson is recalling the BD Phoenix PMIC/ID-108 in vitro diagnostic device because it may produce false resistant results for S. aureus, potentially affecting antibiotic treatment.
Merit Medical Systems is recalling 80 cardiac catheterization kits because header bags may not be fully sealed, potentially compromising sterility and increasing infection risk.
Westmed is recalling 6,000 units of Adult Elongated O2/CO2 Masks because the oxygen delivery tube may not connect securely to the mask adapter, potentially delaying treatment.
ROi CPS LLC is recalling 17,700 custom procedure packs because the gauze sponges inside may be flaking or fraying.
Becton Dickinson is recalling BD Phoenix PMIC/ID-109 because it may produce false resistant results for S. aureus, potentially affecting antibiotic treatment.
Westmed is recalling 37,300 non-rebreather masks because the oxygen tube connection may become loose, potentially delaying patient treatment.
Medtronic is recalling 3,858 Ares Antibiotic-Impregnated Catheters due to a potential seal defect that may compromise sterility and increase infection risk.
Becton Dickinson & Co. is recalling BD Phoenix PMIC-108 IVDs because false resistant results for S. aureus could lead to ineffective antibiotic treatment.
Boston Scientific is recalling 458 Contour VL Variable Length Ureteral Stent Sets because trace amounts of nickel debris were found on the devices during manufacturing.
Becton Dickinson is recalling the BD Phoenix PMIC/ID-107 in vitro diagnostic device because it may produce false resistant results for S. aureus, potentially affecting antibiotic treatment.
Westmed is recalling 600 units of Adult Elongated CO2/O2 Masks because the tubing connection may become loose, potentially delaying oxygen therapy.
Academy Sports + Outdoors is recalling about 6,000 Ozone 500 Density bicycles because loose front wheel hardware can cause instability and falls.
Roche Diagnostics is recalling 7 cobas pro integrated solutions units because configuration settings may cause incorrect clinical results that remain undetected.
Roche Diagnostics is recalling cobas c 503 analyzers and kits because residual reagent transfer can cause inaccurately low results for therapeutic drug monitoring tests.
The USDA FSIS issued a public health alert for frozen chicken sriracha ravioli products that may contain undeclared soy, a known allergen. Approximately 49 pounds of these products are affected across multiple states.
Anticimex is recalling about 2,750 SMART Connect Mini Devices because the power supply can overheat, causing the plastic enclosure to fly off and posing fire and injury risks.