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.
Stop Clopez Corp's Schwinnng Herbal Dietary Supplement Capsules were distributed worldwide via Amazon without FDA approval as a new drug. Consumers should discontinue use immediately.
Infinite Herbs Organic Basil in 2.5 oz, 2.0 oz, and 4 oz containers has been recalled due to potential Salmonella typhimurium contamination. Approximately 235,077 units were distributed across multiple states.
Boston Scientific has recalled Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment that prevents guidewire advancement. The defect affects certain batch numbers in catheters distributed worldwide.
Boston Scientific is recalling Expo 5F cardiac catheters due to material delamination in the inner lining that prevents guidewire advancement. The defect affects 25,617 units distributed worldwide.
Boston Scientific recalled Expo 5F cardiac catheters due to polyurethane delamination preventing guidewire advancement. The defect may cause device failure during medical procedures.
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement during cardiac procedures. The recall affects 4,715 catheters distributed worldwide.
Boston Scientific is recalling certain batches of Expo 5F Selective Angiographic Cardiac Catheters due to polyurethane delamination that prevents guidewire advancement. The recall affects 15,270 units distributed worldwide.
Boston Scientific is recalling specific batches of Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment that prevents guidewire advancement. The affected catheters may not function properly during angiographic procedures.
Apollo Tires is recalling specific Vredestein tires because a contaminated compound may cause steel belts to separate, increasing the risk of a crash.
Diamond Coach is recalling 2023-2024 VIP 2200 transit buses because the seat recliner mechanism may not engage, increasing injury risk during a crash.
Boston Scientific is recalling certain Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment. The defect may prevent proper guidewire advancement during cardiac procedures.
Boston Scientific is recalling Expo 5F selective angiographic catheters due to polyurethane layer delamination and material detachment that prevents guidewire advancement through the device.
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment that may prevent guidewire advancement. The recall affects 15,079 catheters distributed worldwide.
Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement. The recall affects 46,860 units distributed worldwide.
Boston Scientific is recalling certain Expo 5F cardiac catheters due to polyurethane layer delamination and material detachment that may prevent guidewire advancement during procedures. The recall affects 290 catheters distributed worldwide.
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement during cardiac procedures.
Boston Scientific Corporation recalls Expo 5F cardiac catheters due to polyurethane layer delamination and inner lining detachment that prevents guidewire advancement. Affected batch 60535890 has been distributed worldwide.
Boston Scientific recalled Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in certain batches, which can prevent guidewire advancement during cardiac procedures.
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination that prevents guidewire advancement through the catheter lumen.
Boston Scientific is recalling certain Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in the inner lining, which can prevent guidewire advancement.
Boston Scientific is recalling 8,575 Expo 5F Selective Angiographic Catheters due to polyurethane delamination that prevents guidewire advancement. The FDA Class I recall affects devices distributed worldwide.
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters in certain batches due to polyurethane layer delamination that prevents guidewire advancement. The inner lining material may detach, making the catheters unsafe to use.
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination that can prevent guidewire advancement during cardiac catheterization procedures.
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer defects that prevent proper guidewire insertion. Affected devices may experience material detachment in the catheter lining.
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination in the inner lining. The defect prevents guidewire advancement through the catheter, compromising its function during cardiac procedures.