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.
Maquet Cardiovascular is recalling specific batches of Maquet Getinge-BEQ-TOP 15704 Circulatory Circuits because a design feature may prevent proper sterilization of the stopcock ports.
Terumo Medical Corporation is recalling Portico Solo Re-Collapsible Access Systems because the tip may dislodge from the sheath, potentially causing injury.
Avella of Deer Valley, Inc. is recalling 730 prefilled syringes of Bevacizumab 2.5 mg/0.1 mL due to a lack of assurance of sterility.
Suja Life LLC is recalling 90,489 bottles of Organic Kombucha - Peach Ginger because consumers reported finding pieces of glass in the product.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, compromising sterility.
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent sterilization gas from reaching all parts of the device.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent proper sterilization, potentially compromising sterility.
Abbott Vascular is recalling the MitraClip XTR Clip Delivery System because clips may open or become nonfunctional during implantation, requiring additional surgery.
Maquet Cardiovascular is recalling specific Pressure Pigtail devices because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.
Cooper Tire is recalling specific size 235/65R18 tires due to a manufacturing defect that may cause sidewall parting and tire failure.
Maquet Cardiovascular is recalling NICU ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, compromising sterility.
Suja Life LLC is recalling 64,896 bottles of Organic Kombucha - Ginger Lemon due to consumer complaints of finding pieces of glass in the product.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.
U.S. Tov, Inc. is recalling Global Pride Rattan Shoots in Brine because testing found high levels of undeclared sulfites.
Seven Seas International USA LLC is recalling Biltmore Sashimi Grade Smoked Wild Sockeye Salmon because the product tested positive for Listeria monocytogenes.
Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because the design may prevent proper sterilization gas flow, compromising sterility.
Maquet Cardiovascular is recalling specific ECC Pump Packs because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling Rapid Response Universal Packs because a design flaw may prevent proper sterilization of the stopcock ports.
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent sterilization gas from reaching all parts of the device.
Maquet Cardiovascular is recalling specific Sample Manifolds because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.