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.

3051–3075 of 4878

  • SevereNHTSA·22V503000·2023-01-07

    2022 CAN-AM Ryker Motorcycles: Handlebar Stem Bolt Breakage Recall

    CAN-AM is recalling 2022 Ryker motorcycles due to handlebar stem bolts that may break unexpectedly, causing sudden loss of steering control and crash risk.

    Product
    CAN-AM — 2022 CAN-AM RYKER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V391000·2023-01-06

    2023 Entegra Odyssey motorhomes recalled for loose rear axle bolts

    Jayco is recalling certain 2023 Entegra Odyssey motorhomes because bolts securing the rear axle rotor to the wheel hub may be improperly tightened, potentially causing wheel separation and increased crash risk.

    Product
    ENTEGRA — 2023 ENTEGRA ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V481000·2023-01-06

    Truck battery cable defect recall: Western Star and Freightliner vehicles

    Daimler Trucks North America is recalling certain Freightliner and Western Star trucks because the battery cable terminal may break, causing engine stall and crash risk. Dealers will repair or replace the cables at no cost.

    Product
    WESTERN STAR — 2020 WESTERN STAR WJ121
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23720·2023-01-05

    Polaris Sportsman and Scrambler 1000 S ATVs recalled for fire hazard

    Polaris is recalling certain 2020–2023 Sportsman and Scrambler 1000 S all-terrain vehicles because electrostatic discharge can ignite fuel during refueling, creating a fire hazard. The company has received 16 reports of fires, including one personal injury.

    Product
    Model Year 2020-2023 Sportsman 1000 S and Scrambler 1000 S All-Terrain Vehicles (ATVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0212-2023·2023-01-04

    Lukai sweetened jujube products recalled for undeclared sulfites

    Lukai sweetened jujube products are recalled because they contain undeclared sulfites at 17.9 mg per serving. This allergen poses a risk to consumers with sulfite sensitivity.

    Product
    "Lukai sweetened jujube"; 8.3 ounces; red and yellow packaging; back panel states: "Name: Ejiao dates; Ingredients: a nuclear-free golden jujube, donkey-hide gelatin, sugar, honey, maltose, citric acid; Consumption methods: open bags of ready-to-eat, soup, making cakes; Shelf li
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Food)·F-0208-2023·2023-01-04

    Favorina Advent Calendar recalled for potential Salmonella contamination

    Lidl US Trading is recalling Favorina Advent Calendar due to potential Salmonella contamination. Approximately 10,524 units were distributed throughout the United States.

    Product
    Favorina Advent Calendar NET WT. 8.4OZ (240g) Premium Chocolate with a Creamy Filling UPC 4056489516965
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·21V214000·2023-01-03

    RV Chassis steering column defect may cause loss of steering

    Shyft Group is recalling certain 2021-2022 Spartan RV Chassis K1-K4 vehicles. A steering column defect may cause the steering output shaft to disengage, resulting in loss of steering control and crash risk.

    Product
    SPARTAN — 2021 SPARTAN K2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V210000·2023-01-03

    2021 Chevrolet Tahoe seat belt latch may be inaccessible

    GM is recalling certain 2021 Chevrolet Tahoe vehicles because the second-row center seat belt latch may be trapped beneath the trim bezel. Passengers cannot use this seat belt, increasing injury risk in a crash.

    Product
    CHEVROLET — 2021 CHEVROLET TAHOE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23083·2022-12-29

    ZLINE Gas Ranges Recalled for Carbon Monoxide Poisoning Risk

    ZLINE is recalling about 28,000 gas ranges because the oven can emit dangerous levels of carbon monoxide while in use, posing a serious risk of injury or death. The firm has received 44 reports of carbon monoxide emission, including three reports of consumers seeking medical attention.

    Product
    ZLINE 30-inch and 36-inch RG gas ranges
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0203-2023·2022-12-28

    Utopia Brand Enoki Mushroom Recalled Due to Listeria Contamination

    Utopia Foods Inc. is recalling Utopia brand Enoki Mushrooms (200g) due to potential Listeria monocytogenes contamination. Consumers should not consume this product.

    Product
    Utopia brand Enoki Mushroom; Utopia Foods Inc; 200g; Product of China; Distributed by Utopia Foods Inc.; UPC 892891861017; packaged in blue and clear plastic bag
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0205-2023·2022-12-28

    Gamesa Arcoiris Marshmallow Cookies recalled due to Salmonella risk

    Gamesa Arcoiris Marshmallow Cookies with best-before date 28MAR23 are being recalled due to potential Salmonella contamination. Approximately 19,764 boxes were distributed in Texas and California.

    Product
    Gamesa Arcoiris Marshmallow Cookies, Naturally and Artificially Flavored 15.5 Oz, 6 Count UPC 6 86700 10132 4
    Category
    Food
    Distribution
    0 states
  • SevereCPSC·23080·2022-12-22

    Samsung Top-Load Washing Machines Recalled for Fire Hazard

    Samsung has recalled about 663,500 top-load washing machines because the machines can short-circuit and overheat, posing a fire hazard. A free software update is available to resolve the issue.

    Product
    Samsung Top-Load Washing Machines
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0443-2023·2022-12-21

    Arrow AC3 Optimus Intra-Aortic Balloon Pump Battery Failure Recall

    Arrow International recalls AC3 Optimus intra-aortic balloon pumps worldwide due to short battery run-times. The FDA issued a Class I recall affecting all lot and serial numbers.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0431-2023·2022-12-21

    Arrow AutoCAT2 Cardiac Pump Recalled for Short Battery Run-Time Risk

    Arrow International is recalling the AutoCAT2 intra-aortic balloon pump (model AEROAUTOCAT 2 WAVE) due to a potential issue with short battery run-times that may affect patient cardiac support.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0434-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Battery Run-Time Issue

    ARROW INTERNATIONAL is recalling Arrow AutoCAT2 Intra-Aortic Balloon Pumps due to a potential issue with short battery run-times. Affected devices distributed worldwide may have reduced battery endurance.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0447-2023·2022-12-21

    Arrow AutoCAT2WAVE intra-aortic balloon pump recalled for short battery run-times

    Arrow AutoCAT2WAVE intra-aortic balloon pumps are being recalled for a potential issue with short battery run-times. The FDA Class I recall affects 39 units distributed worldwide, manufactured by Arrow International Inc.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0429-2023·2022-12-21

    Arrow AutoCAT2 cardiac pump recalled for short battery run-times

    Arrow International is recalling 2,678 Arrow AutoCAT2 intra-aortic balloon pumps worldwide due to a potential issue with short battery run-times. The FDA classified this as a Class I recall.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0439-2023·2022-12-21

    Arrow AC3 Optimus cardiac pump recalled due to battery issues

    Arrow AC3 Optimus Intra-Aortic Balloon Pumps worldwide are being recalled due to short battery run-times. All lot and serial numbers are affected.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0441-2023·2022-12-21

    Arrow AC3 Optimus Intra-Aortic Balloon Pumps recalled for short battery runtime

    Arrow International is recalling Arrow AC3 Optimus Intra-Aortic Balloon Pumps worldwide due to a potential issue with short battery run-times. The pumps may not operate for the intended duration during critical cardiac care.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0455-2023·2022-12-21

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump Recalled for Short Battery Run-Times

    Arrow International is recalling Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices worldwide due to a potential issue with short battery run-times.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0426-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump recalled for short battery run-times

    Arrow International is recalling 1,394 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0449-2023·2022-12-21

    Intra-Aortic Balloon Pump with Potential Short Battery Run-Times

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pumps are being recalled worldwide due to short battery run-times affecting device operation. Patients using this device should contact their healthcare provider immediately.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0452-2023·2022-12-21

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump Recalled for Battery Runtime Issues

    Arrow International is recalling 127 units of the AutoCAT2WAVE Intra-Aortic Balloon Pump worldwide due to a potential issue with battery runtime.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0454-2023·2022-12-21

    Intra-Aortic Balloon Pump Battery Run-Time Issue Recall

    Arrow AutoCAT2WAVE intra-aortic balloon pumps are recalled due to a potential issue with short battery run-times. Fifteen units distributed worldwide are affected.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0086-2023·2022-12-21

    Injectable iohexol syringes recalled for mislabeled iodine strength

    BayCare Integrated Service Center is recalling 250 iohexol injection syringes mislabeled as 300 mg iodine/mL but actually containing 350 mg iodine/mL. The labeling error could result in dosing mistakes.

    Product
    Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 30
    Category
    Drug
    Distribution
    1 state