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.
AvKARE is recalling 2,396 bottles of Cinacalcet Tablets 60 mg (Lot #44550) distributed nationwide due to CGMP deviations. The tablets contain N-Nitroso-Cinacalcet, a nitrosamine impurity, above acceptable intake limits.
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.
GE Healthcare recalled 11 Optima 520 CT systems that produce progressively rotated scan images in helical, cine, and cardiac modes, potentially affecting diagnostic accuracy.
Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride Extended-Release Capsules (60 mg) due to presence of N-nitroso-Desmethyl-Diltiazem impurity exceeding FDA limits. Approximately 34,848 bottles nationwide are affected.
Sysco Fruit Punch 24-ounce products are recalled due to metal fragments introduced during dextrose production. Consumers should not consume the affected product and contact their retailer for refund or replacement.
Cook Medical HEMO-7-EU Hemospray devices are being recalled because the activation knob may crack or break during use due to manufacturing defects. The affected devices were distributed to Argentina, Brazil, and Israel.
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.
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.
BD recalled BACTEC 9120 Systems because technical support credentials were compromised by an unauthorized actor. Until credentials are updated, there is a risk of unauthorized access to the devices and associated data.
Gordon CHOICE Fruit Punch Mix is being recalled due to metal fragments introduced during production. The affected product was distributed to 29 states.
An unauthorized actor accessed service credentials for Becton Dickinson's BD MAX diagnostic systems. Until credentials are updated, there is risk of unauthorized access that may impact data confidentiality, system integrity, and availability.
Sysco Classic Lemonade Drink Mix is being recalled due to metal fragments introduced during dextrose production. Consumers should not consume the product and should discard it or return it to their retailer.
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.
DYMA BRANDS is recalling REJUV ORIGINALS Low Calorie Orange Drink Mix due to metal fragments introduced during production. The contaminated product was distributed across 29 states.
McKesson Calcium Alginate Dressing Model 3562 is recalled because defects in the primary packaging pouch compromise the sterile barrier. Lot number W00070426 affects approximately 8,000 boxes distributed across Illinois, Texas, and Virginia.
BMW is recalling certain 2025 X3 30 xDrive vehicles because the right-side head curtain air bag may have been assembled incorrectly, risking delayed or improper deployment in a crash.
MEDLINE is recalling four types of dental and oral surgery convenience kits that were manufactured using SafeAir Smoke Evacuation Pencils, which were previously recalled by Stryker.
Medline is recalling medical convenience kits (CLEAN CLOSING PACK and CLEAN CLOSURE PACK GREEN) distributed nationwide because they contain a SafeAir Smoke Evacuation Pencil component that was recalled by Stryker.
Katy's KITCHEN Originals gelatin mix products are being recalled because a damaged sifter introduced metal fragments during manufacturing. The affected flavors are Lemon, Lime, and Orange, distributed across 29 states.
AROMA VITA Hot Cocoa Mix is being recalled due to metal fragments in the product caused by a damaged sifter used during dextrose production.
The Ziehm Vision RFD 3D hand switch can fail when exposed to mechanical stress like dropping, potentially initiating unintended radiation from the x-ray system.
VENOFER (iron sucrose) injection is being recalled nationwide because certain vials may contain glass particles from potential glass delamination. Patients and healthcare providers should contact their pharmacist or healthcare provider immediately.
Apple Wedge Cinnamon Apple Cider is being recalled due to elevated patulin contamination detected in testing. Affected products were distributed to Georgia, North Carolina, South Carolina, and Florida.
Aurobindo Pharma USA is recalling Cinacalcet 30mg tablets nationwide due to N-nitroso Cinacalcet impurity above FDA limits. Patients should contact their healthcare provider about their medication.
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.