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.
Ice Cream House is recalling Trimocha Vanilla ice cream due to potential Listeria monocytogenes contamination. The affected product was distributed in Ohio, New Jersey, and New York.
ICE CREAM HOUSE is recalling 9-inch ice cream pies distributed in Ohio, New Jersey, and New York due to potential Listeria monocytogenes contamination. Consumers should not consume the product.
Future Motion is recalling approximately 300,000 Onewheel self-balancing electric skateboards because they can stop balancing and cause the rider to crash. Four deaths and dozens of injuries including head trauma, fractures, and paralysis have been reported.
HONEY JOY infant swings are recalled due to a suffocation hazard. The product violates federal safety standards because it has an incline angle greater than 10 degrees and was marketed for infant sleep, and infant fatalities have been reported in similar inclined sleepers.
Abbott Medical is recalling approximately 17,394 Proclaim DRG Implantable Pulse Generators worldwide due to reports that patients cannot exit MRI mode on affected devices. This malfunction may prevent normal device operation when mode-switching is needed.
Buffalo Games and Target are recalling Chuckle & Roar Ultimate Water Beads Activity Kits because ingested water beads expand and can cause choking and intestinal obstruction in children. One infant death and one serious injury requiring surgery have been reported.
Dean & Peeler Meatworks is recalling fresh ground beef products due to possible E. coli O157:H7 contamination. The products were shipped to restaurants in the San Antonio, Texas area.
Covidien is recalling MAHURKAR dialysis catheters because the center lumen may be blocked by excess silicone lubricant. This could delay treatment and cause blood clots, hemolysis, or embolism.
Richin Trading Inc is recalling Tim Heung Yuen Black Melon Seed due to undeclared soy and wheat allergens. The product was distributed across 12 U.S. states. Consumers with these allergies should not consume the product.
Zipadee Kids Convertible House Bed Frames and Montessori Floor Beds are being recalled due to spindle spacing that can trap a child's torso while preventing their head from passing through, creating a strangulation hazard. At least two children have become entrapped.
Saffron Inc. is recalling burger buns because labels fail to disclose wheat and sesame allergens present in the product. The affected products were distributed to one distributor in South Carolina.
Day-Lee Foods is recalling frozen chicken potstickers that may contain undeclared milk and eggs. The recall affects products sold in California.
Datascope Corp. recalls Reinforced Introducer Sets because the dilator may fracture during catheter insertion, risking arterial damage and embolization. One patient death has been reported.
Datascope's MEGA 7.5Fr. intra-aortic balloon catheter kits may have introducers that fracture during insertion, risking arterial damage and embolization. The firm has received 10 complaints including 3 serious events and 1 death.
The YAMATO PLUS intra-aortic balloon catheter's introducer dilator may fracture during insertion, risking arterial damage, aortic damage, or blood clots. Datascope has received 10 complaints, including 1 death and 3 serious adverse events.
Datascope Corp. is recalling SENSATION PLUS 8Fr. intra-aortic balloon catheters because the introducer dilator may fracture during insertion, risking blood vessel damage and surgical intervention. The company received 10 complaints, including 1 death.
Datascope's LINEAR intra-aortic balloon catheters may develop a fractured introducer dilator that can injure blood vessels or cause dangerous blockages. The company has received 10 complaints including 1 death and 3 serious adverse events.
Datascope TRANS-RAY IAB catheters may have introducer dilators that fracture during insertion, risking arterial damage or blood clots. The firm reports 1 death and 3 serious injuries.
Datascope's MEGA 8Fr. intra-aortic balloon catheter introducer may fracture during insertion, leaving fragments that can damage blood vessels. The firm has reported 10 complaints, including 1 death.
The SENSATION 7 Fr. intra-aortic balloon catheter introducer dilator may fracture during insertion, potentially damaging blood vessels and requiring surgery. One death has been reported among 10 total complaints.
Datascope's SENSATION PLUS intra-aortic balloon catheter dilator may fracture during insertion, potentially damaging the femoral artery or aorta. The firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
365 Whole Foods Market Organic Tropical Fruit Medley is recalled nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume this product.
SunOpta Grains and Foods Inc. is recalling frozen cherries sold under Great Value, Good & Gather, and Best Choice brands nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume affected products.
Olympus is recalling 17,609 bronchovideoscope units nationwide due to complaints of endobronchial combustion during therapeutic laser procedures, which poses a fire and burn risk to patients.
Honey mustard pretzel products from multiple brands are being recalled due to potential undeclared milk. The recall affects 334,357 bags distributed nationwide.