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.
Holsum Baking Company Warehouse is recalling frozen unbaked biscuits sold as Hilltop Hearth, Mary B's, and Marshall due to a positive Listeria monocytogenes test.
Merit Medical Systems is voluntarily recalling specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.
Vygon is voluntarily recalling 200 units of 3-Way Standardbore Stopcocks because packaging adhesive issues may compromise product sterility.
National Frozen Foods Corporation is recalling frozen green beans due to potential Listeria monocytogenes contamination. The product is sold for foodservice and manufacturing use.
Medtronic is recalling Affinity NT Cardiotomy/Venous Reservoirs because of a possible sterile barrier breach in the pouch.
Harley-Davidson is recalling specific detachable saddlebags because the latching arm may disengage, allowing the bag to separate from the motorcycle while riding.
Med Tec Inc is recalling Protura software versions that may fail to update pedestal location data, potentially affecting treatment table movements.
Arrow International is recalling 5,926 Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.
Forest River is recalling 2018 Glaval Bus Commute vehicles because hazard lights may not function when the ignition is off, increasing crash risk.
Arrow International Inc is recalling specific lots of AGB+ Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.
Innovasis, Inc. is recalling nine lots of 8.5 mm Polyaxial Pedicle Screws due to a risk of breakage. The recall covers 1,010 parts distributed in the United States.
Lemur Group is recalling PL Sleep children's nightgowns because they fail to meet federal flammability standards, posing a risk of burn injuries.
The FDA is recalling 3,816 Endo GIA Auto Suture Universal Articulating Loading Units because the safety interlock may fail, allowing an empty unit to be fired a second time.
Aryzta North America is recalling specific lots of Italian White Bread Dough Sticks because a yeast ingredient may be contaminated with metal fragments.
Medtronic is recalling Affinity NT Cardiotomy Venous Reservoirs due to a possible sterile barrier breach in the pouch.
DeRoyal Industries Inc is recalling 181 custom sterile surgical packs distributed in New York due to a Terumo valve defect causing no flow.
Flexfrost is recalling 1200/4 oz cups of Chocolate Protein Ice Cream due to insufficient pasteurization monitoring measures identified by the Ohio Department of Agriculture.
Aryzta North America is recalling specific lots of Italian White Bread Dough Sticks because a yeast ingredient may be contaminated with metal fragments.
Flexfrost is recalling 3120 4-ounce cups of Protein Ice Cream Coffee because the Ohio Department of Agriculture found insufficient pasteurization monitoring measures.
Boston Scientific is recalling 22,916 units of the Innova Self-Expanding Stent System because the stent may not fully release from the delivery system.
Boston Scientific is recalling 22,916 Innova Self-Expanding Stent Systems because they may not fully release from the delivery system.
Roche Diagnostics is recalling 399 Cobas 8000 Modular Series systems due to a software failure that may reset settings to defaults, creating a risk of incorrect test results.
Fujifilm is recalling 71 units of the Fuji Computed Radiography Mammography Suite because a software error may cause new images to overwrite previous ones in the hospital system.
Arrow International is recalling 601 PICC powered by VPS Stylet kits because they may contain an incorrect catheter length.
Synthes, Inc. is recalling LCP Drill Sleeve 1.5 Drill Bits because they may fail to attach to plates, potentially causing surgical delays or off-center drilling.