Severity 4 of 5
The hazard poses a serious risk of illness, injury, or structural failure. 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.
Montana Compounding Pharmacy is recalling Trimix injectable vials because FDA inspectors observed objectionable conditions that raise concerns about the product's sterility.
Smith & Nephew is recalling R3 Constrained Liners because the locking groove is oversized, which may prevent the locking ring from engaging properly.
Roche is recalling Accu-Chek Spirit Combo insulin pumps because mechanical errors may stop insulin delivery, potentially leading to severe hyperglycemia.
Montana Compounding Pharmacy is recalling Alprostadil injectable vials due to lack of assurance of sterility and objectionable conditions observed during an FDA inspection.
Philips is recalling 31 TruFlight Select PET/CT systems because the Uninterruptible Power Supply (UPS) accessory devices may leak battery acid, overheat, or emit fumes.
Montana Compounding Pharmacy is recalling Hyaluronidase Injectable Solution because FDA inspectors observed objectionable conditions that raised concerns about the product's sterility.
Montana Compounding Pharmacy is recalling Bimix injectable vials because FDA inspectors observed objectionable conditions that raise concerns about sterility assurance.
HeartWare Inc is recalling HVAD systems due to complaints of damaged or bent connection pins in the power supply ports of the VAD controller.
Elgin is recalling 2009-2015 Megawind-MX street sweepers because boom mounting pins may lose retaining pins, allowing the boom to detach and increasing crash risk.
EverGreen is recalling 2015 i-Go, Ever-Lite, Sun Valley, and Ascend travel trailers because wheel studs may break, potentially causing the wheel to detach.
Great Dane is recalling 111 model year 2015 Converter Dolly trailers because a brake valve defect may cause brake drag, leading to overheating, fire, or wheel detachment.
Vactor is recalling 2014-2015 HXX and 2100 Plus trucks, and Guzzler Guzzcavator trucks, because incorrect boiler assembly hardware may cause the unit to detach, increasing crash risk.
Fresca Italia Inc is recalling approximately 36 pounds of pork products produced in Italy that were not inspected at the U.S. point of entry.
Honda is recalling specific 2001-2007 models because the passenger air bag inflator may rupture during deployment, potentially causing serious injury or death.
Newmar is recalling 2015 King Aire and Essex vehicles because tag axle suspension hangers may move, increasing crash risk.
Volkswagen is recalling 2015 Passat vehicles because a brake line may not be properly tightened, potentially causing fluid leaks and reduced braking performance.
Rush Truck Centers is recalling modified Peterbilt 337, 348, and 382 trucks because seat belt anchorages may come unanchored under load, increasing injury risk in a crash.
Winnebago is recalling 2014-2015 Metro Link transit buses because seats may detach from the floor during a crash, increasing injury risk.
Giant Eagle is recalling Apricot Filled Cookies sold over the counter because the labels failed to declare the milk allergen.
Synthes, Inc. is recalling specific lots of Cannulated Drill Bits because they have the potential to break during use. The affected devices were distributed in the US and Canada.
Frontier Natural Products Co-op is recalling Simply Organic Spicy Chili Seasoning because it may be contaminated with Salmonella.
Daimler Trucks is recalling 2008-2009 Sterling Bullet trucks because the driver's air bag inflator may rupture in a crash, potentially causing serious injury.
Frontier Natural Products Co-op is recalling specific lots of organic black peppercorns with garlic due to potential Salmonella contamination.
Frontier Natural Products Co-op is recalling Simply Organic Sweet Basil Pesto Sauce Mix packets because they may be contaminated with Salmonella.
Amy's Kitchen is recalling specific lots of Gluten Free Dairy Free Vegetable Lasagna because a spinach supplier notified them that the ingredient contained Listeria monocytogenes.