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.

2551–2575 of 4878

  • SevereFDA (Food)·F-0739-2023·2023-04-26

    Food Recall: HyVee Hamburger Chili Macaroni Skillet Meal – Undeclared Milk

    HyVee Hamburger Chili Macaroni Skillet Meal (5.2oz) is recalled due to undeclared milk allergen. The product was voluntarily recalled by the manufacturer and is no longer in distribution.

    Product
    HyVee Hamburger Chili Macaroni Skillet Meal, 5.2oz retail carton. UPC: 0 75450-08552 5
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0734-2023·2023-04-26

    Volupta Organic Black Chia Seeds Recalled for Salmonella

    NSI Group LLC is recalling 1,351 pouches of Volupta Organic Black Chia Seeds distributed to a Costco location in San Diego, CA, due to Salmonella detected in product testing.

    Product
    Volupta Organic Black Chia Seeds 64 oz. Best By: 10/31/2025 Stand up pouch. Product of Paraguay
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0704-2023·2023-04-19

    Trader Joe's Frozen Tropical Fruit Blend Recalled for Hepatitis A Risk

    Scenic Fruit Company is recalling Trader Joe's Organic Tropical Fruit Blend and related products distributed nationwide and regionally due to potential Hepatitis A contamination from Mexican strawberries. Five lot numbers with Best By dates from April to June 2024 are affected.

    Product
    Trader Joes Organic Tropical Fruit Blend, frozen, net wt. 16 oz., 24 bags per case, SKU 051191. UPC 00511919. This product contains strawberries from Mexico. Distributed by Trader Joe's Monrovia, CA.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0708-2023·2023-04-19

    Biltmore Smoked Sockeye Salmon Recalled for Potential Listeria Contamination

    Seven Seas International USA LLC is recalling Biltmore Smoked Sockeye Salmon 4 oz packages due to potential Listeria monocytogenes contamination. Lot R4058 with expiration 03-31-2024 is affected.

    Product
    Biltmore Smoked Sockeye Salmon - 4 oz
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0743-2023·2023-04-19

    Kagome Chuno Sauce Recalled for Undeclared Soy Allergen

    Mutual Trading Company is recalling Kagome Chuno Sauce (10 fl oz bottles, 51 cases) distributed to select U.S. states due to undeclared soy allergen, which poses serious health risks for allergic consumers.

    Product
    Kagome Chuno Sauce 30/10 fl oz Stock#24269 Ingredients: Tomato, Apple, Carrot, Brewed Vinegar, Sugar, Glucose, Salk, L-Glutamic Acid, Spice, Corn Starch, Fermented Seasoning, Xanthan Gum, Licorice. Imported By Mutual Trading Co., Inc. El Monte, CA 91731 North American Food Dist.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0744-2023·2023-04-19

    Kagome Tonkatsu Sauce Recalled Due to Undeclared Soy Allergen

    Mutual Trading Company Inc. is recalling Kagome Take Out Tonkatsu Sauce (STOCK #24274) because it contains an undeclared soy allergen. The recall affects 393 cases distributed to CA, AZ, NZ, TX, NM, OK, and HI.

    Product
    Kagome Take Out Tonkatsu Sauce STOCK: #24274 40 packets (8g) in a plastic bag. 15 bags in a box
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0703-2023·2023-04-19

    Frozen Organic Strawberries Recalled for Potential Hepatitis A Contamination

    Frozen Organic Strawberries sold under multiple brands (Kirkland Signature, Trader Joe's, and others) are being recalled due to potential hepatitis A contamination. Do not consume; discard or return to retailer.

    Product
    Frozen Organic Strawberries, Kirkland Signature, frozen, net wt. 4lb., 9 packages per case, Costco Item 904984. UPC 096619140404. Distributed by Costco Warehouse Corporation, Seattle, WA. Product of Mexico.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0701-2023·2023-04-19

    Organic Sliced Strawberries Recalled for Potential Hepatitis A Contamination

    California Splendor, Inc. is recalling 400-lb. drums of 39+1 Organic Sliced Strawberries Refrigerated due to potential Hepatitis A contamination. Product distributed to Oregon and California; consumers should not consume.

    Product
    400-lb. drums of 39+1 Organic Sliced Strawberries Refrigerated
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1313-2023·2023-04-19

    Ivenix Large Volume Infusion Pump Recalled Due to Fluid Ingress Risk

    Fresenius Kabi is recalling the Ivenix Infusion System Large Volume Pump (Model LVP-0004) because fluid ingress can damage the device, causing loss of electrical function and preventing or halting infusion.

    Product
    Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Food)·F-0732-2023·2023-04-12

    Gerber GoodStart SoothePro infant formula recalled due to possible Cronobacter contamination

    Perrigo Nutritionals is recalling Gerber GoodStart SoothePro infant formula due to potential Cronobacter contamination. The recall affects 182,888 cans distributed nationwide and in Canada.

    Product
    Gerber GoodStart SoothePro Infant Formula with Iron. Milk Based Powder. Stage 1, 0 - 12 Months. Nestle Infant Nutrition, Arlington, VA 22209. Packaged in the following sizes: 1. Net Wt 12.4 oz. (351 g) (6 cans per case) UPC 050000-62400 3 2. Net Wt 30.6 oz. (1.91 lb /
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1289-2023·2023-04-12

    Philips Trilogy Evo Portable Ventilators Recalled for Inaccurate Oxygen Delivery

    Philips Respironics is recalling the Trilogy Evo Universal Portable Electric Ventilator (Model DS2000X11B) because it may deliver oxygen below the prescribed level during high-concentration oxygen therapy, potentially depriving patients of adequate oxygen.

    Product
    Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1274-2023·2023-04-12

    FreeStyle Libre Readers Recalled for Battery Swelling and Fire Hazard

    Abbott is recalling over 1.3 million FreeStyle Libre Readers nationwide due to lithium-ion battery swelling, overheating, and fire hazards. Users should stop use if devices show damage, swelling, or excessive heat.

    Product
    FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1287-2023·2023-04-12

    Portable Electric Ventilators May Deliver Insufficient Oxygen During High-Concentration Therapy

    Philips Respironics ventilators may deliver oxygen below required tolerance during high-concentration therapy. The FiO2 sensor may display higher readings than actual delivery, risking insufficient oxygen to patients.

    Product
    Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0691-2023·2023-04-12

    Peanut Butter Pie Recalled Due to Potential Salmonella Contamination

    Desserts by Helen, Inc. is recalling Peanut Butter Pie due to potential contamination from JIF peanut butter manufactured during a recall period in 2022. The recall affects products distributed in Indiana, Kentucky, and Ohio.

    Product
    Peanut Butter Pie, 1 count
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1273-2023·2023-04-12

    FreeStyle Libre Readers recalled due to lithium-ion battery fire hazard

    FreeStyle Libre Reader batteries may swell, overheat, or create fire hazard. Do not use if the device is damaged, cracked, swollen, excessively hot, won't hold charge, or fails Reader Test.

    Product
    FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1275-2023·2023-04-12

    FreeStyle Libre Reader batteries pose fire and swelling hazard

    FreeStyle Libre Reader batteries used in glucose monitoring systems may swell, overheat, or pose a fire hazard. Users should only charge with the included cable and discontinue use if devices show damage, excessive heat, or charging problems.

    Product
    FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1288-2023·2023-04-12

    Trilogy EV300 Portable Electric Ventilator may deliver insufficient oxygen

    The Trilogy EV300 Portable Electric Ventilator may deliver insufficient oxygen during high-concentration therapy due to accuracy deviations. The device's internal oxygen sensor may also display incorrect readings, creating a risk of oxygen under-delivery to patients.

    Product
    Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15B, IA2200X15B, FR2200X14B, ND2200X15B, IT2200X21B, ES2200X15B, DE2200X13B, BL2200X15B, GB2200X15B, EU2200X15B, EU2200X19, EE2200X15B, TR2200X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1322-2023·2023-04-12

    Philips DreamStation respiratory devices recalled for communication issues affecting prescription settings

    Philips DreamStation BiPAP and CPAP devices may experience communication failures with their cloud care management system, potentially preventing proper prescription settings from being downloaded to the device.

    Product
    Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0697-2023·2023-04-12

    Clio Strawberry Granola & Yogurt Parfait Bars Recalled Due to Listeria Risk

    Clio Strawberry Granola & Yogurt Parfait Bars (UPC 854021008152) are being recalled due to possible Listeria contamination. Affected products were distributed to retail stores in Iowa, Illinois, Virginia, Wisconsin, and North Carolina.

    Product
    Clio Strawberry Granola & Yogurt Parfait Bar Net Wt. 1.94 OZ (55g ) UPC: 854021008152 Packaged in a cardboard box.
    Category
    Food
    Distribution
    13 states
  • SevereNHTSA·21V753000·2023-04-09

    Tiffin Wayfarer RV Water Tank Mounting Defect Increases Crash Risk

    Tiffin Motorhomes is recalling 2018-2022 Wayfarer RVs because the rear water tank mounting bolts can fail, causing the tank to fall onto the exhaust pipe. This affects vehicle stability and increases crash risk.

    Product
    TIFFIN — 2018 TIFFIN WAYFARER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V429000·2023-04-06

    2023 IC CE School Bus Steering Gear May Fracture, Causing Loss of Control

    Navistar is recalling certain 2022-2023 IC CE School Buses because their steering gears may have been assembled incorrectly and could fracture, causing a loss of steering control and increasing crash risk.

    Product
    IC BUS — 2023 IC BUS CESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23174·2023-04-06

    Mammut Avalanche Shovels Recalled for Spring Locking Mechanism Failure

    Mammut Sports Group is recalling Alugator Ride 3.0 Hoe and Alugator Ride SE avalanche shovels because the spring locking mechanism can fail during emergency excavation, posing risk of injury or death.

    Product
    Alugator Ride 3.0 Hoe and Alugator Ride SE avalanche shovels
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V339000·2023-04-05

    2022 Freightliner Cascadia trucks recalled for disabled antilock brakes and stability control

    Daimler Trucks North America is recalling approximately 17 certain 2022 Freightliner Cascadia trucks because the antilock brakes and electronic stability control can be manually disabled, violating federal safety standards and increasing crash risk. The company will repurchase affected vehicles.

    Product
    FREIGHTLINER — 2022 FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide