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.
GE Healthcare anesthesia systems may develop cracks in the base, potentially causing the device to tip and fall. The FDA recalled 667 units distributed across multiple U.S. states and countries.
Aesculap Implant Systems is recalling the S4 Cervical Cross Connector L 33-42mm due to insufficient clamping force that may cause connector movement or microparticle abrasion in spinal fusion implants.
Queen Bee Gardens is recalling Honey Caramels Butterscotch due to undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. Consumers with tree nut allergies should not consume this product.
Nephron Sterile Compounding Center is recalling del Nido Cardioplegia Solution due to lack of assurance of sterility. The 1765 bags affected were distributed nationwide.
Nephron Sterile Compounding Center recalls Phenylephrine HCl Injection syringes nationwide due to lack of sterility assurance. Patients with affected lots should contact their healthcare provider.
Chuckanut Bay Foods is recalling Espresso Cheesecake Bites because the product contains undeclared soy lecithin. The label states sunflower lecithin, but soy—a major allergen—is actually present.
Nephron Sterile Compounding Center is recalling 85,300 pre-filled syringes of Anticoagulant Sodium Citrate Solution due to failure to assure sterility. Affected patients should contact their healthcare provider.
Aesculap Implant Systems has recalled certain cervical spine implant connectors due to insufficient clamping force. The defect may allow movement on the rods or cause microparticle abrasion.
Chuckanut Bay Cheesecake Bites Lemon are being recalled due to undeclared soy lecithin in the product. The label incorrectly lists sunflower lecithin as an ingredient, posing a risk to consumers with soy allergies.
ROi CPS LLC is recalling 86 nonsterile medical convenience kits distributed in Missouri because components that were supposed to be sterile were packaged as nonsterile.
Becton Dickinson & Company is recalling BD Connecta Stopcock units worldwide due to a potential housing leakage defect that could interrupt treatment or cause exposure to biohazardous material.
Affected Hill-Rom Centrella Pro+ 36-inch mattresses may have reduced Microclimate Management performance, increasing risk of pressure ulcer development. The failure affects heat and moisture control.
Nephron Sterile Compounding Center is recalling 134,385 epinephrine injection syringes nationwide due to lack of assurance of sterility. No illnesses have been reported.
Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl Injection (1 mg/10 mL) syringes nationwide due to inability to guarantee sterility. Approximately 464,265 syringes across eleven lot numbers are affected.
Nephron Sterile Compounding Center LLC is recalling morphine sulfate injection syringes due to lack of assurance of sterility. The recall affects 4,620 pre-filled syringes distributed nationwide.
RayStation 9B SP1 radiation treatment planning software has an issue where treatment course information may not be propagated to other systems in some workflows. This could potentially affect treatment planning accuracy.
Queen Bee Gardens recalls Truffle Dark Gift Box due to undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. The product poses a risk to consumers with tree nut allergies.
Honeymoons Dark Chocolate Cashew products may contain undeclared tree nuts including pecans, almonds, coconut, macadamia, and walnuts. The product is being recalled from Queen Bee retail locations in Colorado, New Mexico, Wyoming, and nationwide online.
Revie Superfoods Berry Patch oats are being recalled due to potential norovirus contamination from an ingredient used in the product. Approximately 57,960 units were distributed to wholesalers in Pennsylvania, California, Illinois, and Texas.
Queen Bee Gardens is recalling Honeymoons Milk Chocolate Pecan candies due to the potential presence of undeclared tree nuts. Consumers with tree nut allergies should not consume this product.
Cipla is recalling 8,136 bottles of Difluprednate ophthalmic emulsion nationwide due to defective container caps that can break and expose the medication tip, compromising sterility.
Becton Dickinson is recalling approximately 1.96 million BD Connecta Stopcock devices due to potential leakage at the housing component, which could interrupt treatment and expose patients to biohazardous material.
Queen Bee Gardens is recalling Chocolate Sampler 13 oz packages due to undeclared tree nuts. The products may contain pecans, almonds, coconut, macadamia nuts, or walnuts.
Chuckanut Bay Foods LLC recalls Key Lime Cheesecake Bites (Item 32012-56, Lot 2C168A2) because the label fails to declare soy lecithin, posing a risk to consumers with soy allergies.
Aesculap is recalling its S4 Cervical Cross Connector used in spinal fusion surgery due to insufficient clamping force that may cause the connectors to move on the rods or shed particles.