Severity 4 of 5
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.
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.
ResMed is recalling 69 Stellar ventilators because a software and component failure may prevent audible alarms from operating properly.
Lipari Foods Operating Company is recalling approximately 203,881 Fresh Grab Breakfast Muffins because they may be contaminated with Listeria monocytogenes.
Cardinal Health is recalling RoyalSilk gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Cardinal Health is recalling AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Intuitive Surgical is recalling four da Vinci SP Surgical Systems because defective capacitors on circuit boards may cause vision loss or non-recoverable system errors.
Cardinal Health is recalling AAMI 3 Fabric Reinforced Gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
Spectrum Laboratory Products is recalling Ranitidine Hydrochloride powder due to the presence of NDMA impurity. The product was distributed to pharmacies in 11 US states and internationally.
Cardinal Health is recalling RoyalSilk gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Catsmo LLC is recalling approximately 3,800 lbs of Pastrami flavored smoked salmon products due to potential Listeria monocytogenes contamination.
Lipari Foods is recalling Premo Bologna & Cheese Wedge Sandwiches due to potential contamination with Listeria monocytogenes. The products were distributed to food service and retail stores in 15 states.
Volkswagen is recalling 2016-2019 Audi TT vehicles because a fuel tank heat shield bracket may damage the tank in a crash, causing a fuel leak and fire risk.
Cook Inc. is recalling 13,388 Sof-Flex Multi-Length Ureteral Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient.
Lipari Foods is recalling Fresh Grab Chicken Sandwiches due to potential contamination with Listeria monocytogenes. The affected products were distributed to food service and retail stores in 15 states.
Daimler Vans USA is recalling 2019 Mercedes-Benz and Freightliner Sprinter vans because loose EGR pipe screws may allow hot exhaust gases to leak, increasing the risk of a fire.
The H.T. Hackney Co. LLC is recalling Fresh Location Protein Snack Trays due to potential Listeria monocytogenes contamination.
Lipari Foods is recalling Premo King Club Footlong Sub Sandwiches due to potential contamination with Listeria monocytogenes.
Cardinal Health is recalling AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Lipari Foods is recalling Premo and Fresh Grab Chicken Salad Wedge Sandwiches due to potential Listeria monocytogenes contamination.
Bakkavor Foods USA Inc. is recalling Trader Joe's Egg White Salad with Chives because the supplier of boiled eggs notified the firm that the eggs may be contaminated with Listeria monocytogenes.
Lipari Foods is recalling Fresh Grab Ham & Cheddar with Chipotle Mayo sandwiches due to potential contamination with Listeria monocytogenes.
Lipari Foods is recalling Fresh Grab Ham & Swiss on Pretzel Sub Bun sandwiches due to potential Listeria monocytogenes contamination.
Cardinal Health is recalling specific lots of AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Pacific Medical Group Inc. is recalling 628 fetal transducers distributed without 510(k) clearance. The devices may fail to monitor vital signs, posing risks of burns or delayed detection of distress.
Cardinal Health is recalling approximately 7.7 million Royalsilk gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Golden State Foods is recalling Taco Bell Creamy Jalapeno Sauce because a starch ingredient used in its manufacture contained metal fragments.