Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
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.
GE Healthcare CT systems may produce progressively rotated images during helical, cine, and cardiac scans. The issue affects 4 units worldwide and can cause rotations up to 56 degrees.
Albertsons is recalling two green chicken enchilada meal kit products due to Listeria monocytogenes contamination in the cooked chicken. Affected products were distributed across 20 states with sell-through dates up to October 13, 2024.
MEDLINE is recalling surgical convenience kits nationwide because they contain smoke evacuation pencil components from a Stryker product that was previously recalled. The affected kits are used in robotic and laparoscopic surgical procedures.
Orthoscan Inc. is recalling 22 Ziehm Vision FD fluoroscopic x-ray systems. The hand switch may fail when dropped or impacted, potentially initiating unintended radiation exposure.
Becton Dickinson recalled BD BBL Sensi Disc Ampicillin 2 μg test discs due to 65% potency loss over 18 months that may produce false resistant results in susceptibility testing.
AvKARE is recalling Sunitinib Malate 25 mg capsules nationwide due to a label mix-up in lot 100049501. The FDA has classified this as a Class II recall.
Medline is recalling 88 units of tracheostomy convenience kits containing a defective smoke evacuation pencil component that was previously recalled by Stryker. Products were distributed nationwide.
AvKARE is recalling Cinacalcet Tablets 30 mg due to nitrosamine impurity levels exceeding safe limits. Affected bottles nationwide should not be used.
Rising Pharma is recalling 122,925 bottles of Duloxetine 30 mg capsules nationwide due to a manufacturing deviation: the presence of N-nitroso-duloxetine impurity above the recommended interim limit.
GE Healthcare's Revolution ACE CT systems can produce progressively rotated images during certain scan modes. Maximum rotation reaches 56 degrees, potentially affecting diagnostic interpretation.
Rising Pharmaceuticals is recalling Duloxetine DR Capsules 60 mg nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA interim limits. The recall affects approximately 233,003 bottles.
MEDLINE is recalling 102 varieties of surgical convenience kits containing SafeAir Smoke Evacuation Pencils that have been recalled by manufacturer Stryker. The nationwide recall affects 24,754 units.
Jose Madrid Salsa Chipotle Con Queso is being recalled because it contains undeclared Yellow #5 and Yellow #6 food colorants. These additives must be labeled and can trigger sensitivities in some consumers.
Lannett Company is recalling 1,608 bottles of Lisdexamfetamine Dimesylate 10 mg capsules nationwide due to failed content uniformity. The active ingredient may be unevenly distributed in some capsules.
Englewood Cannery is recalling Traditional Country Canning Spaghetti Sauce (16 oz.) because it contains undeclared egg, a common allergen. The affected product was distributed in Alabama and Tennessee.
Gordon CHOICE Fruit Punch Mix is being recalled due to metal fragments introduced during production. The affected product was distributed to 29 states.
Great Dane is recalling 2025 Champion Dry Freight trailers because missing kingpin welds may prevent secure connection, increasing crash risk.
Suzuki is recalling 2023-2025 Burgman 400 scooters because a fuel supply hose may contact a vapor hose, causing fuel leaks that increase fire risk.
Sysco Classic Fruit Punch Drink Mix is being recalled due to metal fragments introduced by a damaged sifter during manufacturing. The affected product (Case UPC 00734730132709, Lot 263 EFA) was distributed across 29 states.
Dyma Brands recalls Thirster Low Cal Fruit due to metal fragments in the product from a damaged sifter during dextrose production. The affected pouches were distributed across 29 states.
Midlab Incorporated is recalling ROYALAB Germ Away Antibacterial Hand Soap (1-gallon, Lot 0711241) due to out-of-specification microbiological test results. The product failed manufacturing quality standards.
Service credentials for BD EpiCenter Data Management System were accessed by an unauthorized actor. This creates a risk of unauthorized access to the software and associated data until credentials are updated.
Rising Pharma recalls Duloxetine Delayed-Release Capsules 20 mg nationwide due to N-nitroso-duloxetine impurity exceeding recommended interim limits, affecting 209,376 bottles.
Glenmark Pharmaceuticals is recalling 4,704 bottles of Diltiazem Hydrochloride extended-release capsules 90mg due to manufacturing contamination with an impurity above FDA limits. Two lot numbers distributed nationwide are affected.
GE Healthcare CT systems may produce progressively rotated images during helical, cine, and cardiac scans. Images can rotate up to 56 degrees, potentially requiring patient rescans.