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.
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.
Boston Scientific is recalling Flexima Regular Kit Nephrostomy Catheter System kits due to potential holes in the sterile barrier pouch that may compromise device sterility.
Boston Scientific is recalling VTC Regular Kit Nephrostomy Catheter System kits due to potential holes in the sterile barrier of the device pouch, which may compromise device sterility.
Bliss Tree Ragi Butter Murukku 200g and 400g packages are recalled due to undeclared milk. Consumers with milk allergies should not consume these products and contact their retailer.
Philips is recalling 109 MultiDiagnost Eleva X-ray systems worldwide due to potential cable hose carrier detachment from broken plastic or bolts, which could cause parts to fall and result in injury.
Boston Scientific is recalling Flexima Biliary Catheter System Kit (Lot #33512376) due to potential holes in the device pouch's sterile barrier, which could compromise device sterility. No illnesses or injuries have been reported.
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.
CareFusion's Alaris System PC Unit Model 8015 infusion pumps are being recalled due to a bent female IUI connector affecting over 125,000 devices. The defect may prevent the device from operating properly or delay infusion or monitoring startup.
MicroVention is recalling 1,370 ERIC Retrieval Devices due to labeling errors showing incorrect expiration dates (5 years instead of actual 3 years). Devices with mislabeled shelf life may be used beyond their true expiration.
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.
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.
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.
Boston Scientific is recalling the vanSonnenberg Sump Catheter System Kit because the sterile barrier pouch may have holes that could compromise device sterility. The recall affects 4 units distributed in the US, Colombia, Philippines, and Russia.
ROi CPS LLC is recalling medical convenience kits distributed with Merit syringes that were subsequently recalled by their manufacturer. Approximately 3,387 kits with multiple lot numbers were affected.
Smith & Nephew is recalling K-Wire surgical devices due to a packaging error that resulted in wrong-sized wires being distributed. Healthcare providers may have received incorrectly sized bone fixation fasteners affecting approximately 73 units.
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.
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.
B. Braun is recalling approximately 4.98 million STREAMLINE FRESENIUS FOR DAVITA hemodialysis bloodline tubes due to risk of improper connector insertion, which could cause blood flow occlusion during dialysis treatment.
Seer Home System ambulatory EEG devices were recalled due to electromagnetic compatibility non-compliance and manufacturing control deficiencies. The issue may affect signal recording reliability in home EEG monitoring.
Bliss Tree Moringa Butter Murukku 400g is recalled because it contains undeclared milk, a common food allergen. Consumers with milk allergies should not consume this product.
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.
B Braun is recalling SL BLOODLINE FOR FMC 2008 SERIES hemodialysis tubing nationwide due to incomplete connector insertion that may cause blood flow restrictions during treatment.
Innovasis is recalling TxHA PEEK and TxTiHA IBF intervertebral fusion devices due to interfacing issues between the implant and inserter that may prevent proper placement. The recall affects 568 devices distributed nationwide.
B. Braun Medical is recalling 19,050 AET36 Anesthesia Extension Sets due to potential product leakage from the Spin Lock Connector caused by excess solvent migration during manufacturing.
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.