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.

4201–4225 of 29102

  • 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
    20 states
  • 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 (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-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-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-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
  • SevereNHTSA·23T007000·2023-10-31

    Toyo Recalls Open Country and Extensa Tires Due to Mold Defect

    Toyo Tire Holdings is recalling certain Open Country and Extensa tires because they may have been produced with the wrong mold, risking tread or sidewall detachment.

    Product
    TIRES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V730000·2023-10-31

    Triumph Rocket 3 rear brake master cylinders may extend stopping distance

    Triumph is recalling certain 2020-2024 Rocket 3 motorcycles because the rear brake master cylinder may fail to move fluid properly, requiring an extended distance to stop. 3,557 units affected.

    Product
    TRIUMPH — TRIUMPH ROCKET 3 R, ROCKET 3 GT, ROCKET 3 TFC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·055-2023·2023-10-31

    Q'Delicia Recalls Ready-to-Eat Empanada Products Produced Without Inspection

    Q'Delicia is recalling ready-to-eat empanada products produced without federal inspection. The products were distributed in Florida and may not be safe for consumption.

    Product
    Q'Delicia Recalls Ready-To-Eat Empanada Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·054-2023·2023-10-30

    Olymel Recalls Ready-to-Eat Ham Products Imported Without Reinspection

    Olymel is recalling approximately 11,016 pounds of ready-to-eat ham products that were imported into the United States without the required import reinspection.

    Product
    Olymel Recalls Ready-To-Eat Ham Products Imported Without the Benefit of Import Reinspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·23V726000·2023-10-30

    Starcraft and Glaval Transit Buses Recalled for Air Compressor Defect

    Forest River Bus is recalling certain 2021-2023 Starcraft and Glaval transit buses because the air conditioning compressor may contact the sway bar, risking loss of steering control.

    Product
    STARCRAFT BUS — STARCRAFT BUS, GLAVAL BUS ALLSTAR XL, ALLSTAR XLT, CONCORDE II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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
  • SevereNHTSA·23V719000·2023-10-26

    Mazda Recalls 2024 CX-90 Plug-in Hybrids for Software Error

    Mazda is recalling 2024 CX-90 plug-in hybrid vehicles because a software error may cause the engine and electric motor to shut down unexpectedly, resulting in a loss of drive power.

    Product
    MAZDA — MAZDA CX-90
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V722000·2023-10-26

    New Flyer Transit Buses Recalled for Transmission Yoke Separation Risk

    New Flyer is recalling 2019-2024 transit buses because the transmission yoke may separate, causing a sudden loss of drive power and increasing crash risk.

    Product
    NEW FLYER — NEW FLYER XN40, XN35, XD35, XD40
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23E084000·2023-10-26

    Akron Brass Recalls Vehicle Multiplex Systems Due to Fire Risk

    Weldon Division of Akron Brass is recalling 8x16 Input-Output Node Vehicle Multiplex Systems because a wiring failure could cause overloaded circuits and fire.

    Product
    ELECTRICAL SYSTEM:WIRING recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V714000·2023-10-25

    Nova Bus Recalls 2015-2019 LFS Models Due to Seat Hardware Defect

    Nova Bus is recalling 2015-2019 LFS and LFS Artic transit buses because incorrectly installed seat hardware may allow seats to detach, increasing injury risk.

    Product
    NOVA BUS — NOVA BUS LFS ARTIC, LFS
    Category
    Vehicle
    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 (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 (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-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
    1 state
  • 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