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.
George J Howe Company, Inc. is recalling 5# Sunflower Seeds C/S due to the presence of undeclared cashew, a tree nut allergen. The product was distributed across multiple U.S. states.
Medline Industries recalled multiple convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The company identified these modifications and notified the FDA of the deviation from the approved 510(k) design.
Abiomed is recalling certain Impella CP Set with SmartAssist (10th Generation) units with affected 14Fr Low Profile Introducer Kits due to potential for thrombus (blood clot) formation during prolonged use.
Joy Gourmet Foods LLC. is recalling Joy Salty Lassi 16 oz. bottles because the product was not adequately pasteurized, which may allow harmful bacteria to survive.
Joy Mango-Pina-Strawberry Lassi 16 oz. is being recalled because it was not adequately pasteurized, creating a risk of harmful pathogens.
Spring & Mulberry Inc. is recalling Blood Orange Date-Sweetened Chocolate bars due to potential Salmonella contamination. Affected products were distributed nationwide.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside FDA-cleared specifications. The recall affects approximately 113,843 kits distributed nationwide.
Abiomed is recalling 3 units of the 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP due to potential for blood clot formation during prolonged use.
Spring & Mulberry Inc. is recalling Earl Grey Date-Sweetened Chocolate bars due to potential Salmonella contamination. The affected product was distributed nationwide.
Central Admixture Pharmacy Services recalls a patient-specific pediatric TPN (Total Parenteral Nutrition) bag because it did not contain copper and famotidine as labeled.
Surgify Medical is recalling Surgify Halo 4.0 mm Extendable surgical burrs due to potential breakage during bi-portal endoscopic spinal surgery. The breakage could create a safety hazard during the procedure.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance.
Spring & Mulberry Inc. is recalling Spring & Mulberry Mango Chili Date-Sweetened Chocolate bars nationwide due to potential Salmonella contamination. Consumers should not consume the product and should dispose of it or return it.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes used in surgical procedures. The manufacturer identified unapproved design changes to the products that were not cleared by the FDA through the 510(k) process.
Pearl Milling Company Original Pancake & Waffle Mix Complete (5.99 oz) is being recalled because it contains undeclared milk and soy allergens. The product was distributed only in Puerto Rico.
Joy Gourmet Foods LLC is recalling Joy Masala Chaash Lassi (16 oz. and 64 oz. sizes) because the product was not adequately pasteurized, which may allow harmful bacteria to survive.
Utz Quality Foods is recalling 1.5 oz and 2 oz bags of Dirty Brand Salt and Vinegar Potato Chips due to potential Salmonella contamination. The affected products were distributed across 32 states.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside FDA-cleared specifications.
Dexcom is recalling two lots of G7 glucose sensors that were stolen during destruction and sold through unauthorized channels. These sensors were designated for destruction due to improper sterilization, increased infection risk, and potential for inaccurate or missing readings.
Utz Quality Foods, LLC is recalling 1.5oz and 8.0oz bags of Zapp's Big Cheezy Potato Chips due to potential Salmonella contamination. The recalled product was distributed across 32 states.
Utz Quality Foods is recalling Zapp's Brand Bayou Blackened Ranch Potato Chips in 2.5oz and 8oz bags due to potential Salmonella contamination. Affected products were distributed across 32 states.
BMW is recalling 428 vehicles from 2023-2025 due to a potential integrated brake system malfunction that may reduce braking power or disable stability controls.
Spring & Mulberry Inc. is recalling Spring & Mulberry Lavender Rose Date-Sweetened Chocolate bars due to potential Salmonella contamination. The recall affects multiple batch lots distributed nationwide.
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) topical applicators due to non-sterility caused by the presence of Aspergillus penicillioides fungal contamination.
Ventec Life Systems is recalling VOCSN+Pro respiratory systems due to a damaged backup battery that may prevent the backup alarm from activating during power loss, delaying caregiver awareness of a hazardous condition.