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.
Glenmark Pharmaceuticals is recalling Naproxen Sodium 250mg tablets nationwide due to a labeling mix-up where Indomethacin bottles may be labeled as Naproxen. Patients could receive the wrong medication.
Certain 2022 Ford Broncos and Rangers have windshields that may not be properly bonded and could separate during a crash, increasing injury risk.
Ford is recalling certain 2022 Lincoln Navigator vehicles due to headlight control module software that may fail, causing side marker and daytime running lights to go dark. This increases crash risk from reduced visibility.
United Packers is recalling Fanta Orange in 12-pack aluminum cans due to potential foreign material. The affected product (Lot No. JUL2924MBD3) was distributed to Alabama, Florida, and Mississippi.
Apotex Corp. is recalling nationwide 25,776 units of Paroxetine Hydrochloride 30 mg tablets due to out-of-specification impurities. Affected lot numbers RV8686, RX0119, and RV2254 expire 08/2024.
BD Insyte Autoguard BC IV catheters may have needles that fail to retract properly, potentially causing contaminated needlestick injuries, blood leakage, and repeated insertion attempts.
Breas Medical is recalling 215 mouthpiece units due to manufacturing defects with unintended slits that may result in insufficient ventilation in mechanical ventilation patients.
Food Unlimited Breakfast Sandwich Bacon Egg & Cheddar Croissants are recalled due to undeclared milk and soy allergens. The affected products have Use By dates from 10/27/2023 to 11/8/2023.
Aizu Olympus colonoscopes with improperly repaired light guide connectors may experience loss of image or suction failure. This could delay treatment and expose patients to contaminated material.
Edwards Lifesciences is recalling 1417 FloTrac Sensors used for intravascular pressure monitoring due to potential flushing difficulties during kit setup. No illnesses or injuries have been reported.
Apotex Corp. is recalling Paroxetine Hydrochloride 40 mg tablets nationwide due to failed quality specifications. Testing found out-of-specification impurity levels in affected lot numbers.
Paroxetine tablets are being recalled for failing specification tests due to higher-than-acceptable levels of a degradation impurity. Approximately 1,941 bottles distributed nationwide are affected.
Medtronic recalled 64,739 ICM LNQ22 LINQ II insertable cardiac monitors due to potential amplified noise or signal reduction that may interfere with heart rhythm recordings.
Abbott is recalling specific lots of the Alinity m HCV AMP Kit due to reports of false positive results and reactive negative controls. The kit detects hepatitis C virus in blood samples.
Edwards Lifesciences is recalling 33,327 Acumen IQ Sensors used for intravascular pressure monitoring due to potential flushing difficulties during setup. The devices are distributed across the US and internationally.
Diet Coke 12oz aluminum cans sold in 12-pack fridge packs are being recalled due to potential foreign material. The recall affects 417 cases with specific lot numbers distributed to Alabama, Florida, and Mississippi.
Food Unlimited-brand Le Croissant Ham & Swiss sandwiches are being recalled due to undeclared milk and soy allergens. Affected products distributed across multiple states should not be consumed by people with these allergies.
Glenmark Pharmaceuticals is recalling 37,200 bottles of Indomethacin 25mg capsules distributed nationwide because the bottles may be labeled as Naproxen instead. This labeling error could cause medication confusion.
Siemens RAPIDPOINT 500 Blood Gas System may produce falsely elevated sodium results due to drug interference from Perhexiline Maleate or Atomoxetine Hydrochloride. This could lead to missed hyponatremia or inappropriate treatment of hypernatremia.
PATH is recalling 28 units of SENTIERO Screening2 hearing examination devices due to potential technical distortions. The affected devices were distributed in Florida, Missouri, Ohio, and Wisconsin.
Certain 2020-2022 Nissan Frontier and Titan vehicles have a defective transmission parking pawl that may not engage when shifted to park, creating a rollaway risk. Dealers will replace the component at no cost.
Aizu Olympus recalls 24 gastrointestinal videoscopes with improperly repaired light guide connectors. The defect may cause loss of image and suction, preventing proper device reprocessing and risking patient infection.
Bonta Natural Artisan Gelato Stracciatella is being recalled due to undeclared soy lecithin. Soy is a major allergen; consumers with soy allergies should not consume this product.
Aizu Olympus gastrointestinal videoscopes (GIF-H190) may have defective repairs that prevent proper sterilization, risking patient exposure to contaminated material. Affected units were distributed to medical facilities in six states.
The rearview camera video output may fail on certain 2020-2023 Ford Explorer and Lincoln vehicles, reducing rear visibility and increasing crash risk. Ford will replace the camera free of charge.