Severity 5 of 5
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Severity 5 (Critical) covers recalls where deaths or serious injuries have been reported, or where the agency itself classified the action as the highest severity (FDA Class I, NHTSA 'death/serious injury reported'). These are the recalls you should treat as urgent — stop using the product immediately and follow the agency's guidance. Common Severity-5 categories are pathogen-contaminated ready-to-eat foods (Listeria, E. coli O157, Salmonella), drug products with confirmed adverse-event reports, and vehicle defects with documented fatal crashes.
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.
Smiths Medical is recalling Portex 550 ml Sterile Water Humidifiers because leaking containers may compromise sterility, potentially exposing patients to infectious agents.
Hy-Vee is recalling specific Pumpkin-Fluff flavored cheesecakes because they tested positive for Salmonella. Consumers in eight states should check their expiration dates and discard affected products.
Hy-Vee is recalling strawberry-flavored cheese cakes because they tested positive for Salmonella. Consumers in eight states should discard the product.
Smiths Medical is recalling Portex 1000 ml Sterile Water USP Pour Bottles because leaking containers may lack sterility assurance, posing a risk of exposure to infectious agents.
Medex Cardio-Pulmonary Inc. is recalling 54,924 Medline Prefilled 550 ml Sterile bags due to leaking containers that may compromise sterility.
Smiths Medical is recalling Portex 550 ml Sterile Water Humidifiers because leaking containers may compromise sterility, potentially exposing patients to infectious agents.
Hy-Vee is recalling Smores-flavored Bettercreme cheesecakes because the product contained an ingredient that tested positive for Salmonella.
Hy-Vee is recalling Lemon Bettercreme Cheesecakes because the product tested positive for Salmonella. Consumers in eight states should discard the product.
Spokane Produce Inc is recalling red lettuce heads due to potential E. Coli O157:H7 contamination. The product was distributed in five western states.
Hy-Vee is recalling turtle-flavored cheesecakes because the product tested positive for Salmonella. Consumers in eight states should discard the affected items.
Hy-Vee is recalling specific sizes of Pumpkin Bettercreme Cheesecake because the product tested positive for Salmonella. Consumers in eight states should check expiration dates and discard affected items.
Spokane Produce Inc is recalling Roast Beef Hoagie sandwiches due to potential contamination with E. Coli O157:H7. The recall affects 73 units distributed in five western states.
Hy-Vee is recalling Oreo-flavored cheesecakes because the product tested positive for Salmonella. Consumers in eight states should discard the affected items.
Nature's Rx is recalling Silver Bullet 10x Capsules sold on eBay because FDA analysis found undeclared sildenafil and tadalafil.
Hy-Vee is recalling Chocolate Bettercreme Cheesecakes because the product contained an ingredient that tested positive for Salmonella.
Bornstein Seafoods is recalling unpasteurized Dungeness crab meat because incorrect Time Temperature Indicators were applied, potentially masking temperature abuse and allowing Clostridium botulinum growth.
Terrific Care LLC is recalling CoaguChek XS PT Test Strips sold via MedEx Supply due to potential for abnormally high INR test results.
Funky Chunky LLC is recalling Nutty Choco Pop because the label fails to declare that the product contains cashews and almonds.
Panola County Processing LLC is voluntarily recalling approximately 59 pounds of smoked sausage products due to a processing deviation that may have led to underprocessing.
Edwards Lifesciences is recalling 459 Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings, potentially leading to misdiagnosis.
Dakota Specialty Milling is recalling Enhanced Flax Flour Blend because an ingredient may be contaminated with Salmonella. The product was distributed in California, Ohio, and Texas.
Edwards Lifesciences is recalling 9 units of Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings.
Jac Vandenberg Inc. is recalling Rio Duero plums sold at ALDI due to potential Listeria monocytogenes contamination.
Jac Vandenberg Inc. is recalling bulk peaches from Chile and Rio Duero brand peaches sold at Aldi due to potential Listeria monocytogenes contamination.
Happy Together, Inc. is recalling 5K Premium Enhancement capsules because FDA analysis found undeclared sildenafil and tadalafil.