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.

5776–5800 of 29108

  • 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
  • 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-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
    2 states
  • 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
  • SevereNHTSA·22V954000·2022-12-23

    Mercedes-Benz Recalls Vehicles Due to Sunroof Panel Detachment Risk

    Mercedes-Benz is recalling 2001-2011 C, CLK, E, and CLS class vehicles because the glass sunroof panel may detach, creating a road hazard.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, MERCEDES BENZ AMG E63, CLK500, CLS550, E550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V955000·2022-12-23

    Mercedes-Benz Recalls GLE and ML Models for Fuel Pump Water Damage

    Mercedes-Benz is recalling 2012-2020 GLE and ML models because water in the spare tire well can damage the fuel pump control unit, causing engine stalls.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ ML350, ML550, ML250, AMG ML63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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-0440-2023·2022-12-21

    Arrow AC3 Optimus intra-aortic balloon pump short battery runtime

    Arrow AC3 Optimus cardiac pumps may experience short battery run-times. The FDA has issued a Class I recall for all units worldwide.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0433-2023·2022-12-21

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

    Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times. All lot and serial numbers are affected.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), 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-0351-2023·2022-12-21

    Arrow MAC Two-Lumen Central Venous Access Kit connector housing defect

    ARROW INTERNATIONAL is recalling Arrow MAC Two-Lumen Central Venous Access Kits due to potential inadequate connection between the top and bottom housings of included Micro Clave Clear Connectors.

    Product
    Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
    Category
    Medical Device
    Distribution
    6 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
  • SevereNHTSA·22V945000·2022-12-21

    Volkswagen Recalls 2015-2016 Beetles for Driver Air Bag Defect

    Volkswagen is recalling 2015-2016 Beetle and Beetle Convertible vehicles because the driver's side air bag inflator may explode, posing a risk of serious injury or death.

    Product
    VOLKSWAGEN — VOLKSWAGEN BEETLE, BEETLE CONVERTIBLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0442-2023·2022-12-21

    Arrow AC3 Optimus IABP Devices Recalled for Short Battery Run-Time Issue

    Arrow AC3 Optimus Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. The FDA issued a Class I recall for these devices.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), 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 (Drugs)·D-0079-2023·2022-12-21

    FDA Recalls Sodium Bicarbonate Injection for Defective Vials

    Exela Pharma Sciences is recalling 489,600 vials of sodium bicarbonate injection nationwide due to defective vials that break and release glass fragments when pressurized during preparation.

    Product
    SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0436-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Battery Runtime Issue

    Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump due to a potential issue with short battery run-times. All lot and serial numbers worldwide are affected.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0448-2023·2022-12-21

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump recalled for short battery runtime

    Arrow AutoCAT2WAVE IABP devices have been recalled due to a potential issue with short battery run-times. The recall covers 112 units distributed worldwide.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), 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
  • 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-0435-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Short Battery Run-Times

    Arrow AutoCAT2 intra-aortic balloon pumps may experience shorter battery run-times than specified, affecting device reliability in cardiac care. The FDA has issued a Class I recall for all affected units worldwide.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), 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