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.
Infusion Options, Inc. is recalling Ondansetron 8 mg/50 mL infusions in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Bleomycin 18 Units / 100 mL NS IVPB products in New York due to a lack of assurance of sterility.
Volkswagen is recalling 2019 Atlas vehicles because a fuel tank weld defect may cause fuel leaks or engine stalling, increasing fire and crash risks.
Infusion Options, Inc. is recalling Injectafer 720 mg and 210 mg IV products in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Mitomycin 10 mg/20 mL IVP syringes in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling various Methotrexate injection products in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling specific Rituximab infusion bags in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Topotecan 1.24 mg/100 mL infusions in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Adcetris 96 mg/100 mL IV infusion bags due to a lack of assurance of sterility. The product was distributed in New York.
Infusion Options, Inc. is recalling Oxytocin 60 units/1000 mL Lactated Ringers IV Solution because the product lacks assurance of sterility. The recall affects 820 bags distributed in New York.
Infusion Options, Inc. is recalling multiple lots of oxaliplatin infusion bags due to a lack of assurance of sterility. The recall is limited to New York.
Degania Silicone is recalling 640 units of Jackson-Pratt Channel Drains because they may break during use or removal, requiring additional surgery.
Infusion Options, Inc. is recalling Dacarbazine infusions in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling DARZALEX 1008 mg / 500 mL IV infusion bags in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Durvalumab infusions in New York due to a lack of assurance of sterility.
Medline is recalling Centurion Convenience Kits containing BD Alaris Pump Infusion Sets due to a tubing defect that may cause over-infusion of medication.
Infusion Options, Inc. is recalling Diphenhydramine 25 mg/50 mL NS infusions in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling RomiPLOStim 700 MCG/1.4 ML SQ syringes in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling specific Abraxane infusion bags in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling various Velcade subcutaneous syringes in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Ifosfamide and Mesna infusion bags in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Vinblastine infusions in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Iron Sucrose 200 mg/100 mL IV products due to a lack of assurance of sterility. The recall is limited to New York.
Infusion Options, Inc. is recalling various Cisplatin infusion products due to a lack of assurance of sterility. The recall is limited to New York.
Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drains because they may break during use, requiring additional surgery.