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.
Oso & Me is recalling approximately 170 children's pajama sets that violate federal flammability regulations for sleepwear, posing a burn risk to children. No injuries have been reported.
Cannondale is recalling 2021–2023 Model Year Dave bicycles because the headtube/downtube weld can become damaged and separate from the frame, creating a fall hazard. No injuries have been reported.
Nutraceutical Corporation is recalling Heritage Store Hydrogen Peroxide Mouthwash because the packaging does not comply with child-resistant packaging requirements, posing a poisoning risk if swallowed by young children.
About 1,570 Vanilla Underground "Minecraft TNT" one-piece pajamas fail to meet federal flammability regulations for children's sleepwear, posing a burn injury risk. Consumers should stop using them immediately and contact Vanilla Underground for a refund.
About 720 Liverpool Football Club children's pajamas fail to meet federal flammability standards for sleepwear, posing a burn-injury risk. The pajamas were sold exclusively online from January 2022 through November 2023.
Country Corner Dairy is recalling Yellow Colby Cheese distributed in Maryland and Virginia due to insufficient pasteurization during manufacturing.
Mennel Milling Company is recalling pizza flour due to potential contamination with metal, wood, gasket material, and sifter balls. Approximately 2.6 million pounds were distributed across Kentucky, Michigan, New Jersey, New York, Ohio, and Pennsylvania.
Fortune cookies manufactured by New World Company are being recalled due to undeclared soy allergen. Consumers with soy allergies should not consume the product.
Country Corner Dairy white cheddar cheese from Maryland and Virginia is being recalled due to inadequate pasteurization during manufacturing. The product was distributed in various sizes in vacuum-sealed packaging.
Philips Azurion 5 X-ray systems with Certeray generators may experience power loss due to a potential short circuit in the power inverter board, potentially delaying or interrupting medical procedures.
AMD Medicom Inc. is recalling Henry Schein Criterion Anti-Fog Earloop Masks Level 3 (Blue) because the masks were produced on non-validated equipment not included in the product qualification process.
Canon Medical System X-ray C-arm systems may display abnormal images due to an internal board manufacturing defect, potentially preventing exam completion and requiring patients to be re-examined with alternative equipment.
Philips Azurion 7 imaging systems may experience power loss due to a potential short circuit in the power inverter, risking delays or termination of diagnostic and surgical procedures.
Mennel Milling Company is recalling donut cake flour products due to potential contamination with metal, wood, gasket material, and sifter balls. The affected product was distributed across six states; no illnesses have been reported.
Mennel Milling Company is recalling hard wheat flour distributed in six states due to potential contamination with metal, wood, gasket material, and sifter balls. Approximately 2.6 million pounds of product may be affected.
Micro Labs Limited is recalling 24,768 bottles of Clobazam 10mg tablets nationwide due to out-of-specification residual solvents. Patients should contact their healthcare provider for guidance.
PTW-FREIBURG's VERIQA software (versions 2.0 and 2.1) may incorrectly calculate gamma passing rates when users exclude voxels below a dose threshold, potentially displaying false positive dose evaluation results.
A framegrabber card malfunction in Philips Allura Xper interventional X-ray systems may cause display failures, preventing proper visualization of medical images and delaying procedures.
Mennel Milling Company is recalling approximately 2.6 million pounds of bread flour due to potential contamination with metal, wood, gasket material, and sifter balls. Affected flour was distributed in six states.
Ascend Laboratories recalls 71,244 sachets of Fosfomycin Tromethamine for failing quality specifications due to organic impurities. Patients with affected lots should consult their healthcare provider.
Mennel Milling Company is recalling 2ND CLEAR 1051664, a bulk animal feed product, due to potential contamination with metal, wood, gasket material, and sifter balls. Affected products were distributed in Kentucky, Michigan, New Jersey, New York, Ohio, and Pennsylvania.
B. Braun Medical recalls 3,890 PERIFIX epidural trays nationwide due to filter straws with incompatible neuraxial connectors instead of standard Luer connectors.
Apotex Corp. is recalling Fluticasone Propionate Nasal Spray (292,752 bottles nationwide) due to potential Burkholderia cepacia contamination from manufacturing deviations. No illnesses reported.
Synapse Cardiology PACS software versions 7.0–7.3.0 may calculate left ventricle mass incorrectly, potentially leading to misdiagnosis or wrong treatment plans. Thirteen units have been distributed in the US and Israel.
Henry Schein Inc. and Glove Club HSI Gloves Inc. are recalling 1,099 vials of Adrenalin (Epinephrine) Injection because the expiration date on the repack pouch label is incorrect. The product was distributed nationwide.