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 containing a combination of drugs 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.
Assurance Infusion is recalling specific lots of Buprenorphine and Fentanyl injection 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 Hydromorphone injection due to a lack of sterility assurance.
Assurance Infusion is recalling 45 vials of Trimix Super injection nationwide due to a lack of sterility assurance.
Assurance Infusion is recalling 19 vials of CJC-1295 and Ipamorelin injections nationwide due to a lack of sterility assurance.
Assurance Infusion is recalling Fentanyl 100mcg/mL injection syringes nationwide due to a lack of sterility assurance.
Assurance Infusion is recalling specific lots of Baclofen and Hydromorphone injection due to a lack of sterility assurance. The affected product was distributed nationwide.
Assurance Infusion is recalling Hydromorphone 20mg/mL injection syringes due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling specific lots of Morphine 7mg/mL injection syringes due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling BPC-157 vials nationwide because the product lacks sterility assurance.
Assurance Infusion is recalling Fentanyl and Sufentanil Injection due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling 166 vials of Testosterone Cypionate 200mg/mL oil injection due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling 358 vials of Trimix Forte injection nationwide due to a lack of sterility assurance.
Assurance Infusion is recalling specific lots of Baclofen and Fentanyl Injection due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling Fentanyl 2000mcg/mL injection syringes because of a lack of sterility assurance. The recall covers products distributed nationwide.
Sun Pharmaceutical Industries is recalling Testosterone Cypionate for Injection due to cGMP deviations and similarity to a previously rejected out-of-specification lot.
Assurance Infusion is recalling 20 mL syringes of BUP 15MG/CLON 600MCG/MORP 30MG/ML injection due to a lack of sterility assurance.
Assurance Infusion is recalling Alprostadil 40 mcg/mL injection vials nationwide due to a lack of sterility assurance.
Assurance Infusion is recalling a specific lot of multi-drug injection syringes due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling specific lots of Morphine 2mg/mL injection syringes due to a lack of sterility assurance.
Assurance Infusion is recalling two syringes of Phenol 2.5% Sterile Solution because of a lack of sterility assurance.
Assurance Infusion is recalling Hydrom 10mg/Suf 200mcg/mL injection syringes due to a lack of sterility assurance. The recall covers nationwide distribution.
Assurance Infusion is recalling 10 vials of Trimix-A injection due to a lack of sterility assurance. The product was distributed nationwide in the United States.