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.
Hydro Pineapple Burn Max Health supplement sachets are being recalled because they contain undeclared sibutramine and were marketed without FDA approval. The product was distributed nationwide.
Promise Pharmacy is recalling MIC+Methyl B12 injection (57 vials, Lot# 06152021@2) distributed across five states due to lack of processing controls that may affect product quality and safety.
Full Tilt Ice Cream, LLC is recalling Dark Chocolate ice cream in 16oz pints and 3-gallon tubs because the ice cream mix did not meet pasteurization specifications. The product was distributed in Washington.
Cordis Corporation recalls SUPER TORQUE MB angiographic catheters worldwide due to risk of entrapment between endovascular devices and vessel wall, potentially causing marker band dislodgement.
Greenpark Compounding Pharmacy is recalling Spironolactone Ophthalmic Solution 0.005 mg/mL due to lack of assurance of sterility. The 15 mL bottles were distributed nationwide.
Purim Health Products EpiGenius Kids Creamy Chocolate powder is recalled due to undeclared milk in an MCT powder ingredient. The product was not labeled to indicate the presence of milk, which is a common allergen.
Cordis is recalling approximately 1,610 SUPER TORQUE PIG PIGTAIL SPECIAL angiographic catheters worldwide because the device can become entrapped between endovascular devices and the vessel wall, potentially causing marker band movement or dislodgement.
Cordis is recalling the SUPER TORQUE MB angiographic catheter (18,730 units) due to risk of entrapment between endovascular devices and vessel wall, which can cause marker band movement or dislodgement. Units were distributed worldwide.
Weis Markets is recalling $7 Crab Cake Meals because they contain undeclared milk, a common allergen. The product was distributed to retail locations in Maryland, Pennsylvania, New Jersey, and West Virginia.
ICU Medical Inc is recalling AMINOSYN II 15% An Amino Acid Injection due to the presence of particulate matter including fibers, hair, and proteinaceous material found in retained samples.
Workhorse Group is recalling 2020-2021 C1000S, C1000M, and 2020 C650 vehicles because they fail to meet multiple Federal Motor Vehicle Safety Standards, increasing the risk of injury, crash, or fire.
DRV Suites is recalling 2021 Mobile Suites and Mobile Suite fifth wheel trailers because improperly tightened brake rotor bolts may loosen or fall off.
Hyundai is recalling 2017 Sonata Hybrid and Tucson vehicles because engine connecting rod bearings may wear prematurely, potentially causing engine damage, fire, or stalling.
PACCAR is recalling 2020-2021 Peterbilt 520 trucks because a missing rear brake valve may cause incorrect brake release timing, increasing crash risk.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. are being recalled due to the risk of bacterial contamination. Healthcare providers and consumers should stop using affected products.
Smiths Medical is recalling NORMOFLO Irrigation Warming sets (Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700) due to potential aluminum leaching when used at lower flow rates with certain solutions and blood products. No illnesses have been reported.
Micro Therapeutics Inc. is recalling 16,169 EV3 Pipeline Flex Embolization Devices due to potential push wire fractures in the delivery system during use.
Smiths Medical recalls NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 (913 units) due to potential harmful aluminum leaching when used at lower flow rates with certain solutions and blood products.
Volvo is recalling 2020-2021 S90, XC60, and XC90 vehicles because a brake component may separate, potentially reducing braking assistance and increasing crash risk.
Ford is recalling 2021 Mustang Mach-E vehicles because the panoramic roof glass may not be properly bonded, posing a risk of detachment.
Trail King is recalling 2019 TK80ACS and TK80AACS trailers because rear suspension beams may crack and detach, increasing crash risk.
Ford is recalling 2021 Mustang Mach-E vehicles because the windshield may not be properly bonded. This defect could allow the windshield to detach during a crash, increasing injury risk.
Altec Industries is recalling 2021 AM50, 55, and 60E aerial devices because improperly machined cylinder rod threads may cause uncontrollable boom movement, increasing injury risk.
SAS Foods Enterprises is recalling approximately 3,768 pounds of frozen beef and chicken empanadas produced without federal inspection and bearing a false USDA mark.
Mercedes-Benz is recalling 2021 S 580 vehicles because a loose fuel pump nozzle may cause engine stalls, increasing crash risk.