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.
Pharmedium Services, LLC is recalling all lots of Midazolam HCl Injection because of a lack of sterility assurance. The recall covers all strengths, doses, and packaging distributed nationwide.
American Pharmaceutical Ingredients LLC is recalling Methylcobalamin (Vitamin B12) for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.
Medtronic is recalling 951 Claria MRI CRT-Ds because a defect may prevent the devices from delivering high or low voltage therapy.
Pharmedium Services, LLC is recalling all lots of Methadone HCl in 0.9% Sodium Chloride due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all lots of Hydromorphone HCl in Sodium Chloride 0.9% due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all lots of Phenylephrine HCl in 0.9% Sodium Chloride due to a lack of sterility assurance.
Flexfrost is recalling 2,927 cups of vanilla protein ice cream because the Ohio Department of Agriculture found insufficient pasteurization monitoring measures.
Pharmedium Services, LLC is recalling Vecuronium Bromide in Sterile Water for Injection due to a lack of sterility assurance. The recall covers all lots remaining within expiry nationwide.
Pharmedium Services, LLC is recalling all Rocuronium Bromide products due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.
Gobugi Holdings Inc. is recalling dried anchovies in California and Oregon because the product is uneviscerated and may be contaminated with Clostridium botulinum.
Pharmedium Services, LLC is recalling all lots of Morphine Sulfate in 0.9% Sodium Chloride nationwide due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all strengths and doses of Succinylcholine Chloride due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all lots of Midazolam HCl in 5% Dextrose due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.
Medtronic is recalling 951 Visia AF ICDs and CRT-Ds because they may fail to deliver high or low voltage therapy.
Pharmedium Services, LLC is recalling all lots of Potassium Chloride in 5% Dextrose due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.
Pharmedium Services, LLC is recalling all strengths and packaging of Glycopyrrolate due to a lack of sterility assurance. The recall covers all lots remaining within their expiry dates nationwide.
Pharmedium Services, LLC is recalling Hydromorphone HCl in 5% Dextrose in all strengths and packaging due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all lots of Ketamine HCl Injection because of a lack of sterility assurance. The recall covers all strengths, doses, and packaging distributed nationwide.
FDA is recalling 17,271 units of the GastriSail Gastric Positioning Device due to reports of gastric or esophageal perforation during surgical procedures.
Pharmedium Services, LLC is recalling all lots of Potassium Chloride in 0.9% Sodium Chloride due to a lack of sterility assurance.
Zimmer Biomet is recalling one ROSA Spine 1.0.2 Stereotaxic instrument because the robot arm may move to the wrong position during surgery.
Pharmedium Services, LLC is recalling Fentanyl Citrate and Ropivacaine HCl injections because of a lack of sterility assurance. The recall covers all lots remaining within their expiry dates nationwide.
Pharmedium Services, LLC is recalling Fentanyl Citrate Injection in all strengths and packaging due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling Dexamethasone Sodium Phosphate in all strengths and packaging due to a lack of sterility assurance.
Hyundai is recalling 2011-2013 Sonata and 2011-2012 Sonata Hybrid vehicles because the air bag control unit may short circuit, preventing safety systems from deploying in a crash.