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.
Gold Standard Baking is recalling Publix Maple Walnut Strip Danishes due to the presence of small metal shavings.
Pharmedium Services, LLC is recalling specific lots of fentanyl citrate injection because confirmed subpotency and stability data do not support the expiry date.
Hospira is recalling 15 vials of Marcaine 0.25% injection because a glass defect allowed water to enter, compromising sterility and reducing drug potency.
Leiter's Compounding is recalling Brilliant Blue G injections because they were produced using recalled filters, raising concerns about sterility.
Gold Standard Baking is recalling Publix Cherry Strip Danishes due to the presence of small metal shavings.
HeartWare is recalling 344 HVAD pumps worldwide because foreign material in the driveline connector could cause electrical faults.
Pharmedium Services, LLC is recalling 54 syringes of ketamine HCl injection because stability data does not support the expiration dates, posing a risk of reduced drug potency.
Brathwaites Oliver Medical is recalling Introes Pocket Bougie endotracheal tube introducers because the device may break during intubation.
Leiter's Compounding is recalling Lidocaine HCl and Phenylephrine HCl injection vials because they were produced using recalled filters, raising concerns about sterility.
Pharmedium Services, LLC is recalling 25 syringes of morphine sulfate 2 mg/mL due to stability data that does not support the expiry date, posing a risk of potential loss of potency.
R.W. Garcia is recalling sweet potato crackers due to the detection of metal fragments in the raw material.
Gold Standard Baking is recalling Publix Guava Strip Danishes due to the presence of small metal shavings.
Gold Standard Baking is recalling The Bakery Strawberry Cheese Danish because of the presence of small metal shavings. The product was distributed nationwide by Walmart.
Polaris is recalling 2015-2017 Slingshot motorcycles because a weak swing arm may fracture, causing loss of vehicle control and increasing crash risk.
Pharmedium Services, LLC is recalling 450 syringes of Hydromorphone HCl because stability data does not support the expiry dates, posing a risk of loss of potency.
Leiter's Compounding is recalling Vancomycin 10 mg/mL injection vials because they were produced using recalled filters, raising concerns about sterility.
Pharmedium Services, LLC is recalling 935 syringes of morphine sulfate because stability data does not support the expiry dates, posing a risk of reduced potency.
Pharmedium Services, LLC is recalling specific lots of Phenylephrine HCl syringes because stability data does not support the expiration dates, posing a risk of reduced drug potency.
Weis Markets is voluntarily recalling 30 bakery products, including muffins and cookies, due to the potential presence of small metal fragments in the sugar topping.
Leiter's Compounding is recalling Cyclopentolate HCl, Tropicamide, and Phenylephrine HCl ophthalmic solution because the filters used to produce the products were recalled, creating a lack of assurance of sterility.
Pharmedium Services is recalling 1,561 syringes of fentanyl citrate because stability data does not support the expiry dates, posing a risk of potency loss.
Pharmedium Services, LLC is recalling 26,079 syringes of midazolam HCl because stability data does not support the expiration dates, posing a risk of reduced potency.
Pharmedium Services, LLC is recalling 1,735 syringes of fentanyl citrate because stability data does not support the expiration dates, posing a risk of reduced drug potency.
Pharmedium Services, LLC is recalling 2,495 syringes of succinylcholine chloride injection because stability data does not support the expiration dates, posing a risk of loss of potency.
Teva Pharmaceuticals USA is voluntarily recalling 11,844 vials of Amikacin Sulfate Injection due to Current Good Manufacturing Practice (CGMP) deviations.