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.
Altec is recalling 2018-2021 Aerial Devices and Digger Derricks because cracks in the subbase bulkhead plate can cause shear plate failure, increasing the risk of injury.
Ideal Specialty Apothecary is recalling Medroxyprogesterone Acetate Injection due to lack of assurance of sterility. The recall affects approximately 57,994 vials distributed nationwide.
Baxter Healthcare is recalling 241,304 Spectrum IQ infusion pumps due to potential medication delivery failure without user alert. The issue may occur during administration set setup or when occlusion alarms are not fully resolved.
Baxter is recalling 146,502 SIGMA Spectrum infusion pumps due to potential medication delivery failures that may occur without alerting clinicians. The issue is linked to administration set setup and occlusion alarm resolution.
Empowered Diagnostics LLC recalled COVID-19 test kits (ImmunoPass, NAB 900-60) sold nationwide without FDA approval. Approximately 2,100 units were distributed without required marketing clearance or authorization.
OXY-1 System consoles used during cardiac support procedures may experience power interruptions that disrupt patient therapy, potentially causing prolonged oxygen deprivation.
Daimler Vans USA is recalling 2016-2021 Mercedes-Benz Metris vehicles because the brake fluid reservoir may detach, increasing crash risk.
Honda is recalling 2021 CBR1000RR-R Fireblade SP motorcycles because an overheating exhaust pipe could melt the oil cooler pipe, causing a leak that increases the risk of fire or crash.
Hyundai is recalling specific 2014-2019 models because a faulty ABS module could cause an electrical short and engine compartment fire.
Aurobindo Pharma USA Inc. is recalling 792 bottles of Pioglitazone 45 mg tablets distributed nationwide due to superpotent tablets and tablets that fail to meet specifications.
Fresh Express Inc is recalling Asian Avocado salad products in 9.7oz packages due to potential contamination with Listeria monocytogenes. The recall affects approximately 1,053 cases distributed across multiple U.S. states and Canada.
Fresh Express Inc is recalling Crisp Greens salad in 12oz. packages due to potential contamination with Listeria monocytogenes. The recall affects products distributed to domestic and Canadian distributors across 20 U.S. states.
Fresh Express Inc is recalling Slivered Onions (1 lb packages) due to potential contamination with Listeria monocytogenes. The product was distributed to domestic and Canadian distributors.
Fresh Express Inc is recalling 2,519 cases of 5oz. Spinach & Arugula salad packages due to potential Listeria monocytogenes contamination. The products were distributed across multiple U.S. states and Canada.
Fresh Express Inc is recalling shredded lettuce products in multiple package sizes due to potential Listeria monocytogenes contamination. The recall affects approximately 211,228 cases distributed across 20 U.S. states and Canada.
Fresh Express Inc is recalling 1,540 cases of Chopped Bacon Ranch salad (12.8oz. packages, codes Z324-Z350) because the product has the potential to be contaminated with Listeria monocytogenes. The salad was distributed to domestic and Canadian distributors.
Fresh Express Inc is recalling Italian salad in 9oz. packages due to potential Listeria monocytogenes contamination. The affected product was distributed to retailers across the United States and Canada.
Fresh Express Inc is recalling Romaine Chopped salad in 32oz. and 2lb. packages due to potential Listeria monocytogenes contamination. The recall affects approximately 9,741 cases distributed across 20 U.S. states and Canada.
Fresh Express Inc is recalling Organic Fresh Herb Mix in 5oz packages due to potential contamination with Listeria monocytogenes. The product was distributed to wholesalers across 20 US states and Canada.
Fresh Express Inc has recalled "Spinach" salad products in 8oz., 10oz., and 16oz. packages due to potential contamination with Listeria monocytogenes. The recall affects 130,592 cases distributed to domestic and foreign distributors.
Philips Respironics recalls 473 Trilogy Evo ventilators due to non-conforming foam that may degrade and release particles. Affected patients risk inhaling or ingesting foam particles and chemicals during device use.
Fresh Express Inc is recalling Organic Spring Mix and Spinach salad products in multiple package sizes due to potential Listeria monocytogenes contamination. The products were distributed to retailers in 20 U.S. states and Canada.
Fresh Express Inc is recalling Bacon Thousand Island salad in 9.4 oz packages due to potential Listeria monocytogenes contamination. The recall affects 9,116 cases distributed across multiple U.S. states and Canada.
Edge Pharma LLC is recalling Vancomycin HCl sterile ophthalmic solution for injection due to lack of assurance of sterility. The affected product was distributed nationwide.
Fresh Express Inc is recalling Spring Mix salad in multiple package sizes due to potential Listeria monocytogenes contamination. The product was distributed across the United States and Canada.