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.
Assurance Infusion is recalling 20 mL syringes of BUP 15MG/CLON 300MCG/FENT 1500MCG/ML injection due to a lack of sterility assurance.
GE Healthcare is recalling 12 units of the Airway Gas Option N-CAiO because displayed oxygen values may be incorrect, potentially causing up to 50% measurement error.
Assurance Infusion is recalling BUP 20MG/SUF 1000MCG/ML Injection syringes due to a lack of sterility assurance. The recall covers nationwide distribution in the United States.
Assurance Infusion is recalling specific lots of Sufentanil 150mcg/mL injection syringes due to a lack of sterility assurance.
Assurance Infusion is recalling a specific lot of BAC/FENT/MORP injection due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling BUP 3 mg/MORP 15 mg/mL Injection syringes due to a lack of sterility assurance. The recall covers specific lots distributed nationwide.
Assurance Infusion is recalling specific syringes of a Baclofen, Clonidine, and Morphine injection due to a lack of sterility assurance.
Assurance Infusion is recalling specific lots of Morphine 6mg/mL injection syringes due to a lack of sterility assurance. The products were distributed nationwide.
Assurance Infusion is recalling Hydrom 1mg/Morp 20mg/Suf 100mcg/mL injection syringes due to a lack of sterility assurance.
Assurance Infusion is recalling BUP 21MG/CLON 252MCG/MORP 20MG/ML Injection syringes due to a lack of sterility assurance. The recall covers products distributed nationwide.
Assurance Infusion is recalling specific lots of a multi-drug injection syringe due to a lack of sterility assurance.
Assurance Infusion is recalling BUP 1MG//ML/HYDROM 7MG Injection in 20 mL syringes due to a lack of sterility assurance. The recall covers nationwide distribution in the United States.
Assurance Infusion is recalling Fentanyl 800mcg/mL injection syringes due to a lack of sterility assurance. The product was distributed nationwide in the United States.
Assurance Infusion is recalling BUP 35MG/MORP 10MG/ML Injection syringes due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling specific lots of HCG 3000U/1ML injections because they lack sterility assurance. The recall covers products distributed nationwide.
Hikma Pharmaceuticals is recalling specific lots of Ketorolac Tromethamine Injection because of the presence of polydimethylsiloxane particles.
Assurance Infusion is recalling BUP 3MG/HYDROM 15MG/ML INJ syringes due to a lack of sterility assurance. The recall covers nationwide distribution.
Assurance Infusion is recalling QUADMIX FORTE in 1 mL vials because of a lack of sterility assurance. The recall covers 5 vials distributed nationwide.
Assurance Infusion is recalling BUP 3.5MG/HYDROM 4MG/ML Injection in 20 mL syringes due to a lack of sterility assurance. The recall covers nationwide distribution.
Assurance Infusion is recalling Morphine 15mg/mL injection syringes due to a lack of sterility assurance. The recall covers products distributed nationwide in the United States.
AvKARE Inc. is recalling specific lots of Dutasteride Capsules, 0.5 mg, because they failed impurity and degradation specifications.
Assurance Infusion is recalling specific lots of Clonidine and Hydromorphone injection due to a lack of sterility assurance.
Assurance Infusion is recalling BUP 23MG/HYDROM 25MG/SUF 100MCG/ML Injection syringes due to a lack of sterility assurance. The recall covers nationwide distribution.
Assurance Infusion is recalling specific lots of Trimix Forte 4 injection because the product may lack sterility assurance.
Assurance Infusion is recalling Fentanyl and Sufentanil Injection in 20 mL syringes due to a lack of sterility assurance.