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.
Fortune cookies from New World Company are recalled for containing undeclared soy allergen. The 1 lb retail bags were distributed in California to consumers.
The framegrabber card in Philips Azurion interventional X-ray systems may fail to display diagnostic images properly, potentially delaying procedures.
3M recalled 764,580 Specialty Blade Assemblies for surgical clippers due to risk of burns from overheating. The blade can reach temperatures exceeding 77°C if left running improperly.
Lupin Pharmaceuticals recalls Voriconazole for Oral Suspension (40mg/mL) due to missing or incorrect package inserts on affected batches distributed in Ohio, Illinois, and New Jersey.
Mallinckrodt recalls TERLIVAZ (terlipressin) injection due to temperature excursion during shipping. A cGMP deviation may compromise drug stability.
Bestco LLC is recalling Kroger Cherry Cough Drops due to potential glass and silicone particulates in the product. The recall affects product distributed nationwide.
AMD Medicom Inc. is recalling Henry Schein Criterion Level 3 Earloop Masks because they were produced on non-validated equipment not included in the initial product qualification.
Country Corner Dairy is recalling WHITE COLBY CHEESE products due to improper pasteurization. The recalled products were distributed to Maryland and Virginia.
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.
Apotex Corp. is recalling Fluticasone Propionate Nasal Spray (292,752 bottles nationwide) due to potential Burkholderia cepacia contamination from manufacturing deviations. No illnesses reported.
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.
Mennel Milling Company is recalling R01001 ENR SPRING FLR flour due to potential contamination with metal, wood, gasket material, and sifter balls. Consumers should not use affected product.
W.L. Gore's GORE VIABIL Short Wire Biliary Endoprosthesis may be mislabeled regarding drainage holes, risking extended procedures, infections, and unplanned device removal in 24 units distributed in Georgia.
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.
Olympus Corporation of the Americas is recalling ESG PK Cutting Forceps because the jaw may fracture during pre-procedure inspection or during the procedure, posing a potential injury risk.
B. Braun Medical recalls 3,890 PERIFIX epidural trays nationwide due to filter straws with incompatible neuraxial connectors instead of standard Luer connectors.
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.
Mennel Milling Company is recalling HARD E6 1036 bulk product distributed across six states due to potential contamination with metal, wood, gasket material, and sifter balls. No illnesses have been reported.
Patterson Procedure Earloop Masks (ASTM Level 3, blue) are being recalled because units were produced on non-validated equipment. The recall affects 180 cases with lot numbers 2339 and 2342, distributed across six states.
Philips has recalled certain Allura Xper interventional X-ray systems because the disk bay component may fail, potentially preventing system operation and imaging procedures.
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.
New World Company is recalling bulk cases of Fortune cookies distributed in California due to undeclared wheat and soy allergens that pose a risk to consumers with these allergies.
Mennel Milling Company is recalling non-human consumption feed products due to potential contamination with metal, wood, and gasket material. Approximately 2.6 million pounds were distributed across six states.
Mennel Milling Company is recalling approximately 2.6 million pounds of DRIED SOFT 75 ENR 134348 due to potential contamination with metal, wood, gasket material, and sifter balls.
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.