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.
Leader brand Lubricant Eye Drops (0.6% Propylene glycol) are recalled nationwide due to non-sterility concerns. Consumers should discontinue use immediately.
The FDA recalled approximately 210,192 bottles of Leader brand Lubricant Eye Drops due to non-sterility that could allow contamination. All lots distributed nationwide are affected.
Detectors in Philips BrightView X gamma cameras may fall unexpectedly due to component failure, risking patient injury including fractures and lacerations.
Big Island Candies is recalling Makana Brownie Assortment Boxes distributed in Hawaii due to undeclared peanut allergen and potentially wrong products in some boxes, posing serious risk to consumers with peanut allergies.
Cardinal Health is removing Monoject brand syringes due to manufacturing changes and rebranding efforts. The removal includes Luer-Lock and ENFit connection models distributed nationwide in the US and Canada.
Rugby brand Lubricating Tears Eye Drops have been recalled nationwide for non-sterility. Kilitch Healthcare India Limited initiated the voluntary recall of 56,520 bottles due to potential contamination concerns.
Cardinal Health is removing all Monoject sterile syringes and enteral syringes due to manufacturing changes and rebranding efforts. These products are distributed across the U.S. and Canada.
Rite Aid is recalling all lots of Lubricant Gel Drops due to non-sterility concerns. The product was distributed nationwide.
Cardinal Health 200, LLC is recalling all sizes of Monoject brand sterile syringes (both Luer-Lock and ENFit enteral types) due to manufacturing and rebranding changes. The recall expands previous correction actions to a complete product removal.
Cardinal Health Monoject Enteral Syringes with ENFit connections are recalled due to compatibility issues with certain syringe feeding pumps. The manufacturer recommends they not be used with enteral syringe feeding pumps.
Cardinal Health is removing Monoject sterile syringes in multiple sizes due to manufacturing and rebranding changes. The recall affects products distributed nationwide in the US and Canada.
The detector in Philips BrightView XCT gamma cameras may fall unexpectedly due to component failure. If it falls below the center of the gantry, it could cause abrasion, contusion, laceration, or fracture to patients' lower limbs.
Rite Aid is recalling lubricant eye drops due to non-sterility concerns. All lots of the Carboxymethylcellulose Sodium 0.5% product are affected.
Cardinal Health is recalling all sizes of its Monoject sterile syringes (Luer-Lock and ENFit models) nationwide due to manufacturing and rebranding changes. The FDA classified this as a Class I recall.
CVS Health brand Lubricating Gel Drops are being recalled due to non-sterility concerns. The voluntary recall affects approximately 110,832 bottles distributed nationwide.
Target brand High Performance Lubricant Eye Drops have been recalled nationwide due to non-sterility. The manufacturer, Kilitch Healthcare India Limited, initiated the voluntary FDA Class I recall affecting 401,568 bottles.
Philips BrightView gamma camera detectors may fall due to component failure, potentially causing patient injury including lacerations and fractures. The FDA is recalling all affected units.
Cardinal Health Monoject enteral syringes (6, 12, 35, 60 mL) have compatibility issues with certain feeding pumps. The affected lots should not be used with enteral syringe feeding pumps.
Kilitch Healthcare India Limited is recalling 7,200 bottles of Lubricant Gel Drops distributed nationwide by Rite Aid due to non-sterility concerns. The manufacturer voluntarily initiated the recall.
CVS brand Multi Action Relief Drops are being recalled nationwide due to non-sterility, which could allow microbial contamination in the product. The voluntary recall covers all lots of the eye drops.
CVS Health brand Lubricant Eye Drops are being recalled due to non-sterility concerns. Kilitch Healthcare India Limited initiated this voluntary recall affecting 386,256 bottles distributed nationwide.
Cardinal Health Monoject enteral syringes (6, 12, 35, 60 mL) in Lot 230503 and 230701 have compatibility issues with certain feeding pumps and should not be used.
Kilitch Healthcare is recalling all lots of Velocity Pharma Lubricating Eye Drop due to non-sterility issues. The product was distributed nationwide; consumers should stop using it immediately.
Rite Aid is recalling 7,296 bottles of lubricant eye drops nationwide due to non-sterility. The FDA has classified this as a Class I recall.
Eye Irritation Relief drops are being recalled nationwide due to non-sterility. The FDA classified this as a Class I recall affecting 10,944 bottles distributed across all production lots.