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.
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.
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.
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.
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.
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.
Philips recalls Azurion X-ray imaging systems due to potential cable hose carrier detachment from broken plastic or bolts, which may cause parts to fall and create injury risk.
Mazor Robotics is recalling 94 Mazor X surgical navigation devices due to software errors that cause screen lag or screw-tracking mismatches during orthopedic procedures.
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.
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.
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.
Smith & Nephew issued a voluntary recall of K-Wire bone fixation fasteners due to a packaging error where packages contained the wrong wire diameter than labeled.
B. Braun is recalling 9,864,165 Streamline Bloodline Sets nationwide due to incomplete patient connector insertion. The defect may restrict fluid flow during hemodialysis and cause therapy delays.
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.
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.
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.
Safeguard US Operating LLC is recalling the HAWK Warming Grid (Item 59-300) due to an incorrect expiration date. The affected units may not function safely if used beyond the actual expiration date.
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.
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.
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.
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.
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.
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.
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.
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.
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.