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.

1726–1750 of 4878

  • SevereNHTSA·22V367000·2023-11-05

    School buses recalled for steering wheels that may loosen and detach

    Navistar is recalling certain 2022-2023 IC BUS school buses. The steering wheel retaining nut may have been tightened incorrectly, allowing the steering wheel to loosen or detach. Owners should not drive their vehicles until repaired.

    Product
    IC BUS — 2023 IC BUS EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V176000·2023-11-03

    2022 Volkswagen Tiguan and Taos Suspension Knuckles Recalled

    Volkswagen is recalling certain 2022 and 2021 vehicles because rear suspension knuckles may corrode, crack, and break, potentially causing loss of stability and increasing crash risk.

    Product
    VOLKSWAGEN — 2022 VOLKSWAGEN TIGUAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V104000·2023-11-02

    Tesla Model S Side Curtain Air Bag Inflator Defect

    Tesla is recalling 2021-2022 Model S vehicles due to side curtain air bag inflators that may have been assembled incorrectly. This could cause delayed air bag deployment during a crash, increasing injury risk.

    Product
    TESLA — 2022 TESLA MODEL S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0150-2024·2023-11-01

    Monoject 60 mL Syringes Recalled for Infusion Pump Compatibility Issues

    Cardinal Health is recalling 457,200 Monoject 60 mL Luer-Lock tip syringes due to demonstrated compatibility issues with certain infusion pump systems. The affected syringes may fail to function correctly with these pumps.

    Product
    Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0124-2024·2023-11-01

    Infusomat Large Volume Pump False Occlusion Alarm May Interrupt Medication

    B. Braun's Infusomat Large Volume Pump battery pack may sound a false occlusion alarm, causing the device to stop pumping. This interruption of high-risk medications can lead to hemodynamic instability and serious medical consequences.

    Product
    8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0123-2024·2023-11-01

    B. Braun Infusomat Large Volume Pump may stop delivering medication due to false alarm

    The Infusomat Large Volume Pump may incorrectly sound an occlusion alarm and stop delivering high-risk medications, potentially causing serious complications.

    Product
    8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0298-2024·2023-11-01

    Whole cantaloupe recall due to possible Salmonella contamination

    Eagle Produce LLC is recalling whole cantaloupe (Kandy brand) in multiple count cartons due to possible Salmonella contamination. The product was distributed to 20 states and Washington D.C.

    Product
    Whole cantaloupe, Brand name Kandy 11 count carton, 8 count carton, 9 count carton, 15 count carton d. Container description; Red Corrugated Paper Carton or Black Plastic RPC.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0148-2024·2023-11-01

    Monoject 20 mL Syringes Recalled for Infusion Pump Compatibility Issues

    Cardinal Health is recalling 4.9 million Monoject 20 mL Luer-Lock syringes due to compatibility and recognition issues with infusion pumps. Affected lot numbers from 2022 and 2023 were distributed nationwide.

    Product
    Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0067-2024·2023-11-01

    ION Sinus Spray recalled nationwide for microbial contamination

    The FDA has recalled ION Sinus Spray due to microbial contamination of the non-sterile product. All lots are affected regardless of expiration date.

    Product
    ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0145-2024·2023-11-01

    Monoject 1 mL Tuberculin Syringes Recalled for Infusion Pump Compatibility Issues

    Cardinal Health recalls approximately 3.1 million Monoject 1 mL Tuberculin Syringes due to demonstrated compatibility and recognition issues with syringe infusion pumps. Nationwide distribution affected.

    Product
    Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0147-2024·2023-11-01

    Monoject 12 mL Syringes Recalled for Infusion Pump Compatibility Issues

    Cardinal Health recalls 3 million Monoject 12 mL Luer-Lock syringes due to demonstrated compatibility issues with syringe infusion pumps that may affect medication delivery.

    Product
    Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0302-2024·2023-11-01

    Orgain Protein Powder Recalled for Undeclared Sesame Allergen

    Orgain is recalling its Organic Protein & 50 Superfoods Protein Powder with Probiotic (chocolate flavor) due to undeclared sesame allergen. Consumers with sesame allergies are at risk of allergic reaction.

    Product
    Organic Protein & 50 Superfoods Protein Powder with Probiotic - Chocolate flavor
    Category
    Food
    Distribution
    33 states
  • SevereFDA (Devices)·Z-0146-2024·2023-11-01

    Monoject 6 mL Syringes Recalled Due to Infusion Pump Incompatibility

    Cardinal Health is recalling Monoject 6 mL Luer-Lock syringes (approximately 3.9 million units) nationwide due to demonstrated recognition and compatibility issues with syringe infusion pumps.

    Product
    Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0111-2024·2023-11-01

    ResMed Astral ventilators recalled for power loss and failed alarms

    ResMed recalls Astral ventilators due to a battery fault that can cause sudden power loss. The backup alarm system may fail to alert users due to supercapacitor degradation.

    Product
    Astral 100 and Astral 150 ventilators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0300-2024·2023-11-01

    Kroger Collard Greens recalled for potential Listeria contamination

    Kroger brand collard greens packaged in 16oz bags are being recalled due to potential Listeria monocytogenes contamination. Consumers should not consume the affected product.

    Product
    Kroger Collard Greens packaged in plastic 16oz bag - 8 bags per case
    Category
    Food
    Distribution
    0 states
  • SevereCPSC·24013·2023-10-26

    Best Buy Recalls Insignia Pressure Cookers Due to Burn Hazard

    Best Buy is recalling about 930,000 Insignia pressure cookers because incorrect volume markings on the inner pot can cause consumers to overfill the unit, leading to hot food and liquids being ejected and causing burn injuries.

    Product
    Insignia pressure cookers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0094-2024·2023-10-25

    Sapphire Infusion Pumps recalled for software air-detection failure

    Sapphire Infusion Pumps with software revisions 16.10.1 or 16.10.2 may fail to detect air in the infusion line, potentially causing life-threatening air embolism. Approximately 1,383 units have been distributed nationwide.

    Product
    Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0046-2024·2023-10-25

    TheraBreath for Kids Oral Rinse Recalled for Yeast Contamination

    FDA recalls TheraBreath for Kids Oral Rinse due to microbial contamination identified as Candida parapsilosis yeast. Approximately 5,316 bottles distributed nationwide are affected.

    Product
    TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6 97029 70000 6, manufactured for Church & Dwight Co, Inc., Ewing, NJ 08628
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0075-2024·2023-10-25

    Olympus High-Flow Insufflation Unit Model UHI-4 Recalled for Cardiac Complications

    Olympus recalls the UHI-4 High-Flow Insufflation Unit used in laparoscopic surgery after reports of patients experiencing cardiac arrhythmias and short cardiac arrests during procedures. Incidents may result from over insufflation of the abdominal cavity.

    Product
    Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0291-2024·2023-10-25

    Lotus Pine Nut Mooncakes Recalled for Undeclared Egg Allergen

    Sheng Kee Bakery is recalling Large 4-Lotus Pine Nut Mooncake Gift Boxes because they contain undeclared egg, a major allergen. The product was distributed in California, Illinois, Texas, Georgia, Washington, and New Jersey.

    Product
    Large 4- Lotus Pine Nut Mooncake Gift Box
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0049-2024·2023-10-25

    Betaxolol Hydrochloride tablets recalled due to oxycodone contamination

    KVK-Tech's Betaxolol Hydrochloride tablets (10 mg, lot 17853A) are being recalled nationwide due to potential contamination with oxycodone tablets. Patients should stop using affected bottles immediately and contact their healthcare provider.

    Product
    BETAXOLOL HYDROCHLORIDE — BETAXOLOL HYDROCHLORIDE (BETAXOLOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0292-2024·2023-10-25

    Large 4-Red Bean Mooncake Gift Box Recalled for Undeclared Egg Allergen

    Sheng Kee Bakery is recalling Large 4-Red Bean Mooncake Gift Boxes distributed in six states due to undeclared egg allergen. Consumers with egg allergies should not consume the product.

    Product
    Large 4- Red Bean Mooncake Gift Box
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0047-2024·2023-10-25

    FDA Recalls Sucralfate Oral Suspension Due to Bacillus Cereus Contamination

    VistaPharm is recalling 180 bottles of Sucralfate Oral Suspension nationwide due to Bacillus cereus contamination, a Class I recall. The affected lot (810300, expiring October 2023) should not be used.

    Product
    SUCRALFATE — SUCRALFATE (SUCRALFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0289-2024·2023-10-25

    Sheng Kee Bakery Mooncakes Recalled for Undeclared Egg Allergen

    Sheng Kee of California is recalling Large 4-Date Mooncake Gift Boxes due to undeclared egg allergen. The product was distributed to multiple U.S. states.

    Product
    Large 4- Date Mooncake Gift Box
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0293-2024·2023-10-25

    Oasis Mediterranean Cuisine Hommus Chips Recalled Due to Undeclared Sesame

    La Perla Inc is recalling Oasis Mediterranean Cuisine Thin & Crunchy Sea Salt Hommus Chips because sesame is not declared on the label. The product was distributed in Ohio with a Best By date of 12/21/23.

    Product
    Oasis Mediterranean Cuisine - Thin & Crunchy Sea Salt Hommus Chips packaged in 6oz printed bags, 12 bags per case.
    Category
    Food
    Distribution
    0 states