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 specific syringes of a multi-drug injection due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling specific lots of Clonazepam and Fentanyl injection due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling Hydrom 1mg/Morp 20mg/Suf 100mcg/mL injection syringes due to a lack of sterility assurance.
AvKARE Inc. is recalling specific lots of Dutasteride Capsules, 0.5 mg, because they failed impurity and degradation specifications.
Assurance Infusion is recalling Bi-Mix 30 mg/1 mg/mL injections because of a lack of sterility assurance. The affected vials were distributed nationwide.
Assurance Infusion is recalling specific lots of Testosterone Cypionate 200mg/mL oil due to a lack of sterility assurance. The affected vials were distributed nationwide.
Toyota is recalling 1997-2000 Celica, RAV4, and Supra vehicles because driver air bag inflators may rupture or underinflate in a crash.
Assurance Infusion is recalling a specific lot of buprenorphine and fentanyl injection due to a lack of sterility assurance. The product was distributed nationwide.
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 8MG/CLON 100MCG/HYDROM 20MG/ML Injection syringes due to a lack of sterility assurance.
Hikma Pharmaceuticals is recalling specific lots of Ketorolac Tromethamine Injection because of the presence of polydimethylsiloxane particles.
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.
Veggie Noodle Co is recalling Cece's Veggie Co. brand Fresh Veggie Ramen with Chicken Broth due to potential contamination with Listeria monocytogenes.
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 specific lots of a Clonazepam and Morphine injection because of a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling specific lots of multi-drug injection syringes because of a lack of sterility assurance.
Assurance Infusion is recalling specific lots of a multi-drug injection syringe due to a lack of sterility assurance.
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 45 vials of Trimix Super injection nationwide due to a lack of sterility assurance.
Assurance Infusion is recalling Fentanyl 3000mcg/mL injection syringes due to a lack of sterility assurance. The affected lots were distributed nationwide.
Assurance Infusion is recalling specific lots of Buprenorphine and Fentanyl injection due to a lack of sterility assurance.
Assurance Infusion is recalling a specific lot of BUP 20MG/CLON 300MCG/FENT 2000MCG/ML Injection due to a lack of sterility assurance.
Assurance Infusion is recalling Fentanyl and Sufentanil Injection in 20 mL syringes due to a lack of sterility assurance.
Edwards Lifesciences is recalling QuickDraw Venous Cannulas because the device may separate from its connector if used for more than six hours, potentially causing significant blood loss.