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.
Kodiak Cakes LLC is recalling 7,300 boxes of Kodiak Protein-Packed Power Waffles due to soft plastic film contamination. Consumers should not consume the affected product.
B. Braun Medical is recalling STREAMLINE LONG hemodialysis bloodline tubing because the patient connector may fail to fully insert into the Locksite, potentially causing blood flow obstruction during dialysis treatment.
B Braun's STREAMLINE FRESENIUS bloodline tubing used in hemodialysis may have a design issue where incomplete insertion of the patient connector prevents proper blood flow during certain procedures. Patients receiving dialysis may experience treatment delays.
Endo retrieval pouches are recalled because the tube may detach and fall into the surgical site during use. Approximately 81,241 units distributed in Georgia, Missouri, and Pennsylvania are affected.
Boston Scientific is recalling 89 units of Flexima APDL Drainage Catheter Systems because holes in the sterile barrier may compromise device sterility.
B Braun Medical Inc. is recalling Streamline Bloodline Sets because incomplete connector insertion may cause flow restrictions during hemodialysis.
Flagstone Foods LLC is recalling Wegmans Pecan Blend because it contains undeclared almonds, a common allergen. The product was distributed to nine states: DC, DE, MA, MD, NC, NJ, NY, PA, and VA.
CareFusion's Alaris Syringe Module Model 8110 infusion pumps are being recalled because affected units may have bent female connectors that can prevent device operation and delay infusions. Approximately 20,145 units have been distributed worldwide.
PHILIPS medical X-ray imaging systems may have a cable hose carrier that can detach due to broken plastic or bolts, potentially causing parts to fall and injure clinical staff.
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized pneumatic tubing in the reagent storage module, which can cause air leaks and compressor failures, potentially leading to test errors and delayed results.
Safeguard US Operating LLC is recalling the HAWK Advanced Hypothermia Management Set due to incorrect expiration dates on affected units. The product may not perform reliably if used after the incorrect date.
Medline is recalling 4,831 Contro-Bulb Syringes due to potential sterile barrier breach during transportation. The recall affects two lot numbers and applies nationwide.
GE Healthcare is recalling three ViewPoint imaging systems due to a software vulnerability in Mirth Connect that could allow unauthorized access and manipulation of patient data.
Bliss Tree Curry Leaves Butter Murukku is recalled due to undeclared milk. The product was distributed to retailers in CA, NJ, GA, AZ, MD, and nationwide online.
Cypress Medical Products recalls Acceava Respiratory Strep A diagnostic test kits nationwide due to a classification error that caused them to be shipped to customers without proper licensing.
CareFusion recalls approximately 10,460 Alaris PCA Module Model 8120 infusion pumps worldwide due to potentially bent female IUI connectors that may prevent proper device operation and delay treatment initiation.
Carbon Medical Technologies is recalling the BiomarC EX Fiducial Marker System because patients did not receive the required MRI Insert component needed for safe use during MRI procedures.
Medtronic is recalling CareLink 2090 Programmers (serial number prefixes PKK0 and PKK1) worldwide due to potential autonomous cursor motion when Finger Touchscreen capability is enabled with software version 3.2 or higher. Approximately 18,788 units are affected.
Bliss Tree Millet Butter is being recalled because it contains undeclared milk, a common allergen. The product was distributed to wholesalers and retailers in five states and to online customers nationwide.
Siemens Healthcare's ADVIA Chemistry Microalbumin diagnostic test may produce falsely low results. Eight lots do not meet High-Dose Hook Effect and Prozone Effect specifications, potentially affecting microalbumin detection accuracy.
Tornier, Inc. is recalling one lot of the Stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS shoulder implant due to bacterial endotoxin exceeding safety specifications. The 5 affected units were distributed in Illinois, Wisconsin, Arizona, Nevada, and South Dakota.
Bliss Tree Millet Butter Ribbon Pakoda is recalled because it contains undeclared milk. The product was distributed to retailers and wholesalers in five states and nationwide online.
Aston Martin is recalling certain 2024-2025 DBX707, DB12 and 2025 Vantage vehicles because the engine oil cooler hose may split, resulting in a loss of oil and oil pressure.
Triple E is recalling 2024 Unity and Wonder motorhomes because transposed weight rating labels could lead to vehicle overloading and increased crash risk.
Motiv Power Systems is recalling specific 2017-2023 electric chassis vehicles because a missing wiring harness component may cause a loss of drive power, increasing crash risk.