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.
SterRx is recalling fentanyl citrate injection nationwide due to lack of assurance of sterility. The recall affects approximately 10,660 bags of the product.
SterRx is recalling 684 bags of epinephrine in 0.9% sodium chloride injection nationwide due to lack of assurance of sterility. The product is supplied to hospitals and healthcare facilities.
SterRx is recalling EPINEPHrine 2 mg per 250 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects 2,779 bags distributed across the U.S.
SterRx is recalling Fentanyl Citrate in 0.9% Sodium Chloride Injection (2.5 mg per 250 mL) distributed nationwide due to lack of assurance of sterility.
SterRx is recalling 1,428 bags of Norepinephrine in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The product is a prescription injectable medication.
SterRx is recalling PHENYLephrine HCl 40 mg per 250 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects approximately 20,640 bags distributed across the United States.
SterRx is recalling dilTIAZem HCl 125 mg per 125 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects 24,300 bags distributed across the United States.
SterRx is recalling Midazolam in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The recall affects approximately 36,360 bags distributed across the United States.
SterRx is recalling epinephrine in 0.9% sodium chloride injection (5 mg per 250 mL) nationwide due to lack of assurance of sterility. Affected lots are identified by codes S21255/BXA, S21264/BXH, and S21328/BZO.
Teligent Pharma has recalled 6,816 bottles of Lidocaine Hydrochloride Topical Solution 4% nationwide due to the drug being superpotent. The recall is voluntary and involves Lot #16345 with expiration date 01/2024.
SterRx is recalling 2,886 bags of Sodium Bicarbonate in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The affected product may pose a risk to patients who receive this intravenous medication.
SterRx is recalling 121,584 bags of Norepinephrine 4 mg per 250 mL injection nationwide due to lack of assurance of sterility. The drug is used to treat low blood pressure in critical care settings.
SterRx is recalling 1,044 bags of Norepinephrine 16 mg per 250 mL in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The affected product carries NDC 70324-002-01 with lot code S21194/CDW.
Rosenbauer America is recalling 2018-2022 fire trucks because fuel tubes may crack, causing high-pressure leaks that could lead to fire.
Stealthstation and Synergy Cranial surgical navigation systems may display an incorrect biopsy needle position due to software synchronization failure. This could result in prolonged surgery, additional procedures, or tissue injury.
Dakota Tom's and Market Fresh branded Chicken Salad Croissant sandwiches are being recalled because they contain undeclared egg and milk. Consumers who have allergies to these ingredients should not consume the product.
Cardiovascular Systems Inc recalls WIRION Embolic Protection System devices (6Fr) because the filter assembly may become difficult to withdraw, and the device may tear or separate, creating a risk of blood clot embolization.
Efficient Laboratories is recalling Rompe Pecho guaifenesin expectorant in 4 fl oz and 6 fl oz bottles due to microbial contamination of non-sterile products. The affected product was distributed nationwide.
Denver Solutions, LLC (doing business as Leiters Health) is recalling Moxifloxacin 1 mg/mL intracameral injection solution because vials labeled as 1 mg/mL may actually contain 5 mg/mL, creating a serious dosing error risk.
Efficient Laboratories is recalling approximately 4,026 bottles of Rompe Pecho Max Multi-Symptoms cough and cold medicine nationwide due to potential microbial contamination of the non-sterile product.
Hyundai is recalling certain 2020-2021 Santa Fe, 2021 Sonata, and Elantra vehicles due to improper windshield bonding that may cause detachment during a crash. Dealers will reinstall windshields at no cost.
Polaris is recalling about 8,800 RZR and GENERAL recreational off-road vehicles because the steering wheel can separate, causing loss of control and crash risk. Polaris has received 33 reports of broken or cracked steering wheel spokes, including five rollovers and two injuries.
Kraft Heinz Foods Company is recalling Country Time Lemonade drink mix powder in five sizes due to potential contamination with glass and metal fragments. The recall affects approximately 289,221 cases distributed nationwide and internationally.
Big Game Treestands' 2021 The Captain model (batch 2M-0121) is recalled because plastic-coated cable crimps can slip during use, releasing the standing platform and causing falls. Two injuries have been reported from ten documented incidents.
International Golden Foods Inc is recalling Al Kanater Tahini Sesame Seeds (1 lb plastic bottles) due to potential Salmonella contamination. The affected product was distributed to retailers and distributors in Illinois and Michigan.