The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

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.

1926–1950 of 4878

  • SevereFDA (Devices)·Z-2378-2023·2023-08-23

    Dialysis catheter recall: excessive lubricant causes center lumen obstruction

    A dialysis catheter product is being recalled due to excessive lubricant coating in the center lumen, which may cause full or partial obstruction. The blockage could delay treatment and increase risk of blood clots and hemolysis.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2410-2023·2023-08-23

    Phaco Standalone Tips Recalled Due to Plastic Debris Risk

    Alcon is recalling 444,372 units of Phaco Standalone Tips worldwide because the plastic wrench included with the product can generate plastic debris when over-tightened, potentially injuring patients.

    Product
    Phaco Standalone Tips
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2372-2023·2023-08-23

    FDA Recalls MAHURKAR Dialysis Catheters Over Obstruction Defect Risk

    Covidien's MAHURKAR dialysis catheters are recalled due to excessive lubricant on the catheter tip causing partial or complete obstruction. This risks delaying treatment and may cause blood clots, hemolysis, or embolism.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2387-2023·2023-08-23

    Dialysis Catheters Recalled by FDA for Tip Obstruction Risk

    Covidien is recalling MAHURKAR acute dialysis catheters because the center lumen tip may be occluded by excessive silicone-based lubricant. Obstruction could delay treatment or cause embolism and thrombosis.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit REF: 8888345611HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·23783·2023-08-17

    Ubio Labs power banks recalled due to fire hazard

    Costco is recalling approximately 350,000 Ubio Labs power banks (model PWB1071) that can overheat and ignite. The company has received three fire reports, including one on a commercial flight with four smoke inhalation reports and one minor burn injury.

    Product
    Ubio Labs power banks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1382-2023·2023-08-16

    Vans Gluten-Free Original Waffles Recalled for Undeclared Wheat

    Vans gluten-free original waffles are being recalled because they contain undeclared wheat. Consumers with wheat allergies should not consume this product.

    Product
    Vans gluten free ORIGINAL WAFFLES, NET WT. 9 OZ (255G), INGREDIENTS: GLUTEN FREE BLEND (BROWN RICE FLOUR, POTATO STARCH, RICE FLOUR, SOYFLOUR), WATER, EXPELLER PRESSED CANOLA OIL***CONTAINS SOY***DISTRIBUTED BY: VAN'S INTERNATIONAL FOODS OAKBROOK TERRACE, IL 60181 USA***UPC# 0
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-1421-2023·2023-08-16

    Food Recall: ONO Vegan Blueberry Protein Overnight Oats for Undeclared Milk

    ONO LLC is recalling ONO Vegan Blueberry Muffin Protein Overnight Oats because they contain undeclared milk, a common allergen. The product was distributed nationwide and poses a risk to consumers with milk allergies.

    Product
    ONO Vegan Blueberry Muffin Protein Overnight Oats, 2.75oz. UPC 01-95893-47024-2
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1380-2023·2023-08-16

    Member's Mark Breaded Mozzarella Sticks Recalled for Undeclared Egg and Soy

    Member's Mark Breaded Mozzarella Sticks are being recalled because they contain undeclared egg and soy allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    Member's Mark brand BREADED MOZZARELLA STICKS; 72 STICKS; 2 RESEALABLE BAGS INCLUDED; NET WT 5 LB (2.26 kg); UPC 078742226880
    Category
    Food
    Distribution
    5 states
  • SevereCPSC·23262·2023-08-16

    Gree Recalls 1.56 Million Dehumidifiers Due to Fire and Burn Hazards

    Gree is recalling approximately 1.56 million dehumidifiers sold under brand names including GE, Kenmore, SoleusAir, Seabreeze, and Norpole because they can overheat, smoke, and catch fire, creating fire and burn hazards.

    Product
    Dehumidifiers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1366-2023·2023-08-16

    Energy balls recalled for undeclared sesame allergen

    Betty Lou's Paleo Java Nuts About Energy Balls are being recalled due to undeclared sesame in the product. The recall affects packages distributed nationwide.

    Product
    Betty Lou's Paleo Java Nuts About Energy Balls with Cacao, Coffee & Pumpkin Seeds, shelf-stable, 12-month shelf life, 1.5 oz (42g) package and 12/1.5 oz. packages per display box. Packages are sold individually (UPC 0 1607352146 5) or packaged into 12-ct display box (UPC 0 16073
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1401-2023·2023-08-16

    Cava Spicy Hummus recalled nationwide for undeclared sesame

    Cava Spicy Hummus (8oz, UPC 89832800227) is being recalled because it contains undeclared sesame. The product was distributed nationwide; consumers with sesame allergies may be at risk.

    Product
    Cava Spicy Hummus UPC 89832800227 Net Wt. 8oz./226.8 g Packaged in clear plastic container. 12 units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1383-2023·2023-08-16

    Corsican Sheep's Milk Cheese Recalled for Potential Listeria Contamination

    A Corsican sheep's milk cheese has been recalled due to possible Listeria monocytogenes contamination. The product was distributed to a customer in Oregon.

    Product
    FABRIQUE' EN CORSE TOMME CORSE AU LAIT DE BREBIS***ANTOINE OTTAVI FROMAGER***aFFINAGE 3 A' 5 MOIS SARL Fromagerie Ottavi 20240 Ghisonaccia Corsica
    Category
    Food
    Distribution
    0 states
  • SevereCPSC·23256·2023-08-10

    Sensio Electric and Stovetop Pressure Cookers Recalled for Burn Hazard

    Sensio Inc. is recalling approximately 860,000 electric and stovetop pressure cookers because the lid can unlock and be removed during use, causing hot contents to splash out and burn consumers. The company has received 63 incident reports, including 61 burn injuries with some involving second and third degree burns.

    Product
    Electric and stovetop pressure cookers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V792000·2023-08-10

    2023 Ford E-450 Rear Axle Rotor Bolts May Loosen, Causing Wheel Separation

    Ford is recalling certain 2023 E-450 vehicles because rear axle rotor bolts may be improperly tightened, risking wheel separation and increasing crash risk. Dealers will replace affected assemblies at no charge.

    Product
    FORD — 2023 FORD E-450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23780·2023-08-10

    Polaris RZR XP Turbo and Turbo S Off-Road Vehicles Clutch Fracture Fire Injury

    Polaris recalls about 27,300 Model Year 2021 RZR XP Turbo and RZR Turbo S recreational off-road vehicles because the clutch can fracture and eject fragments, causing fires and injuries. Owners should stop using the vehicles and contact Polaris for a free clutch replacement.

    Product
    Model Year 2021 RZR XP Turbo and RZR Turbo S Recreational Off-Road Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1302-2023·2023-08-09

    Pamana Mini Fruit Jelly Cup Recalled Due to Choking Hazard

    Foremost Foods International, Inc. is recalling Pamana brand Mini Fruit Jelly Cups (11,040 units) distributed in the United States and Canada due to a potential choking hazard. Consumers should stop using the product immediately.

    Product
    Pamana brand Mini Fruit Jelly Cup 35.27 oz. Assorted Flavors 6 units per case Item #416705
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·23V625000·2023-08-09

    2025 Ford E-350 Recalled for Transmission Park Pawl Defect

    Ford is recalling 2025 E-350 trucks and related models due to a transmission park pawl casting defect that may not fully engage, potentially causing vehicle rollaway.

    Product
    FORD — 2025 FORD E-350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1303-2023·2023-08-09

    Pamana Brand Lychee Jelly Cups recalled for potential choking hazard

    Foremost Foods International, Inc. is recalling Pamana Brand Mini Fruit Jelly Cup in Lychee flavor due to a potential choking hazard affecting 11,040 units distributed in the United States and Canada.

    Product
    Pamana Brand Mini Fruit Jelly Cup 35.27 oz. Lychee Flavor 6 units per case Item #416704
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2281-2023·2023-08-09

    Impella RP Flex cardiac pump recalled for thrombus formation risk

    The Impella RP Flex cardiac pump has been recalled due to a higher-than-expected rate of blood clot formation. Blood clots may reduce cardiac support or cause hemolysis.

    Product
    Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V626000·2023-08-09

    Lincoln Aviator and Ford Explorer battery defect poses fire and power-loss risk

    Ford is recalling 2020-2022 Lincoln Aviators and Ford Explorers with 3.0L plug-in hybrid engines. A high-voltage battery manufacturing defect may cause battery failure, loss of drive power, and fire risk.

    Product
    LINCOLN — 2020 LINCOLN AVIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1081-2023·2023-08-09

    Prescription Birth Control Tablets Recalled for Failed Stability Testing

    Lupin Pharmaceuticals is recalling TYDEMY birth control tablets due to failed stability testing. Consumers should contact their healthcare provider.

    Product
    TYDEMY — TYDEMY (DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1304-2023·2023-08-09

    Pamana Brand Mini Fruit Jelly Cups Recalled for Choking Hazard

    Foremost Foods International is recalling Pamana Brand Mini Fruit Jelly Cups due to a potential choking hazard. Approximately 11,040 units distributed in the United States and Canada are affected.

    Product
    Pamana Brand Mini Fruit Jelly Cup 35.27 oz. Mango Flavor 6 units per case Item #416706
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·23V413000·2023-08-06

    Jeep Grand Cherokee Models Recalled for Detaching Rear Coil Springs

    Chrysler is recalling certain 2022-2023 Jeep Grand Cherokee and 2021-2023 Jeep Grand Cherokee L vehicles. Rear coil springs may detach while driving, creating a crash risk; dealers will repair them free.

    Product
    JEEP — 2021 JEEP GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V155000·2023-08-03

    Ford Recalls 2022-2023 Bronco for Steering Gear Lock-Up Defect

    Ford recalls 2022-2023 Broncos for steering gear damage that can lock up the steering wheel and cause loss of steering control, increasing crash risk.

    Product
    FORD — 2022 FORD BRONCO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V154000·2023-08-03

    2023-2024 International trucks recalled for loose battery box bolts

    Navistar is recalling certain 2023 and 2024 International trucks because battery box mounting bolts may be loose or missing. Loose bolts could allow the battery box to detach, creating a road hazard and increasing crash risk.

    Product
    INTERNATIONAL — 2023 INTERNATIONAL MV
    Category
    Vehicle
    Distribution
    Distributed nationwide