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.

2801–2825 of 29098

  • SevereFDA (Devices)·Z-2609-2024·2024-09-04

    PORTEX Bivona Neonatal Tracheostomy Tubes May Tear Due to Manufacturing Defect

    Smiths Medical is recalling specific lots of PORTEX Bivona Neonatal Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear, affecting device positioning.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2612-2024·2024-09-04

    Tracheostomy Tubes Recalled for Possible Flange Tearing Due to Manufacturing Defect

    Smiths Medical is recalling specific lots of PORTEX Bivona pediatric and neonatal tracheostomy tubes because the securement flange may tear due to a manufacturing defect. The recall affects multiple tube sizes distributed worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1793-2024·2024-09-04

    Popsicle Recall: Yummy Brand Swirly Ices Contain Undeclared Milk

    Yummy brand Swirly Ices popsicles are recalled due to undeclared milk allergen. The recall affects 282 boxes distributed across nine states.

    Product
    Yummy brand Swirly Ices Assorted Flavors Net Wt. 2.3 ounces (65g)x 8 popsicles, Total Net Wt. 18.34 ounces (520g) UPC: 734690007574. Contains Fruity Melon, Churning Cherry, Berry Blast, and Tropical Tornado flavored popsicles
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-1792-2024·2024-09-04

    Yummy Swirly Ices Churning Cherry Popsicles Recalled for Undeclared Milk

    Yummy brand Swirly Ices Churning Cherry popsicles are being recalled because they contain undeclared milk, posing a risk to consumers with milk allergies.

    Product
    Yummy brand Swirly Ices Churning Cherry flavor Net Wt. 2.3 ounces (65g)x 8 popsicles, Total Net Wt. 18.34 ounces (520g) UPC:734690007543 Also packaged in 30 count packs
    Category
    Food
    Distribution
    9 states
  • SevereNHTSA·24V646000·2024-08-30

    E-One Recalls Cyclone and Typhoon Vehicles Due to Crossmember Defect

    E-One is recalling 2022-2024 Cyclone and Typhoon vehicles because a broken engine crossmember can damage the cooling fan, potentially causing an engine stall and increasing crash risk.

    Product
    E-ONE — E-ONE CYCLONE II, CYCLONE N, TYPHOON N
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·025-2024·2024-08-30

    Hickory Hollow Jerky Recalls Beef and Bacon Jerky Produced Without Inspection

    Hickory Hollow Jerky is recalling approximately 6,229 pounds of beef and bacon jerky produced without federal inspection. The products were distributed in five states and online.

    Product
    Hickory Hollow Jerky — Hickory Hollow Jerky Recalls Ready-To-Eat Jerky Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    5 states
  • SevereCPSC·24352·2024-08-29

    Glow in Dark Party Supplies Toy Sets Recalled for Battery Ingestion Hazard

    Glow in Dark Party Supplies Toy Sets sold on Amazon contain button cell batteries in Bunny Ears Headbands that can be easily accessed by children, posing a serious ingestion hazard. The sets violate federal battery-operated toy regulations.

    Product
    Glow in Dark Party Supplies Toy Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1788-2024·2024-08-28

    Meijer Dunking Cookies Recalled for Undeclared Milk Allergen

    Meijer Inc is recalling Meijer Dunking Cookies Chocolate Chip (10 oz) due to undeclared milk. The product poses a risk to consumers with milk allergies.

    Product
    MEIJER DUNKING COOKIES CHOCOLATE CHIP, 10oz in clear plastic container. UPC 7-13733-71297-2
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2587-2024·2024-08-28

    ClotTriever XL Catheter instructions updated to prevent device entrapment and embolism

    Inari Medical has updated instructions for the ClotTriever XL Catheter (30 mm) to prevent device entrapment and pulmonary embolism. Approximately 2,488 units distributed worldwide are affected.

    Product
    ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0638-2024·2024-08-28

    FDA Class I Recall: B. Braun Sodium Chloride Injection for Particulate Matter

    B. Braun Medical Inc. is recalling 63,444 containers of 0.9% Sodium Chloride Injection USP nationwide due to the presence of particulate matter. This intravenous medication may pose a serious health risk if administered to patients.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2637-2024·2024-08-28

    McGRATH MAC EMS Video Laryngoscope Battery Management System Recall

    Covidien is recalling McGRATH MAC EMS Video Laryngoscopes due to a battery management system defect that may deplete below design specifications, creating risk of thermal events and explosion. About 10,449 units were distributed worldwide.

    Product
    McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0641-2024·2024-08-28

    Acetaminophen Aspirin Caffeine Tablets Recalled for Missing Drug Facts Labels

    Aurohealth LLC is recalling Acetaminophen, Aspirin and Caffeine tablets because some bottles are missing the manufacturer's label containing drug facts information. Affected product was distributed in NJ, NY, and PA.

    Product
    ACETAMINOPHEN ASPIRIN AND CAFFEINE — ACETAMINOPHEN ASPIRIN AND CAFFEINE (ACETAMINOPHEN, ASPIRIN AND CAFFEINE)
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0635-2024·2024-08-28

    FDA Recalls Acetaminophen Injection Due to Labeling Mix-up

    Hikma Pharmaceuticals is recalling Acetaminophen Injection because bags of Dexmedetomidine HCl were found packaged inside Acetaminophen-labeled overWraps. The error could result in patients receiving the wrong intravenous medication.

    Product
    ACETAMINOPHEN — ACETAMINOPHEN (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·24V643000·2024-08-28

    Volkswagen ID.4 passenger airbag inflator fasteners may be loose

    Volkswagen is recalling certain 2023-2024 ID.4 vehicles because the fasteners securing the passenger frontal airbag inflator may be loose, so the airbag may not deploy as intended.

    Product
    VOLKSWAGEN — VOLKSWAGEN ID.4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24E072000·2024-08-26

    USK Internacional Recalls Tie Rod and Drag Link Assemblies

    USK Internacional is recalling certain tie rod and drag link assemblies due to improperly heat-treated ball studs that may break, potentially causing a loss of steering control.

    Product
    STEERING:LINKAGES:TIE ROD ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V633000·2024-08-23

    Jaguar Recalls 2019 I-PACE Vehicles Due to High-Voltage Battery Overheating Risk

    Jaguar is recalling 2,760 2019 I-PACE vehicles because the high-voltage battery may overheat, increasing the risk of a fire. Owners should park outside and limit charging to 80% until repairs are complete.

    Product
    JAGUAR — JAGUAR I-PACE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V637000·2024-08-23

    Great Dane Recalls 2025 Everest SS Trailers Due to Welding Defect

    Great Dane is recalling 2025 Everest SS refrigerated trailers because improperly welded support gear bracing mounts may cause the trailer to collapse.

    Product
    GREAT DANE — GREAT DANE EVEREST SS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24347·2024-08-22

    Head Rush Technologies TRUBLUE Speed Auto Belay Devices Fall Hazard

    Head Rush Technologies is recalling about 220 TRUBLUE Speed Auto Belay Devices because the backup brake can fail to activate, posing a fall hazard and risk of serious injury or death. Consumers should immediately stop using the devices and contact the manufacturer for a free inspection and repair.

    Product
    TRUBLUE Speed Auto Belay Devices
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V629000·2024-08-22

    Salem and Wildwood trailer tires may contact chassis components and fail

    Forest River is recalling certain 2024-2025 Salem SBF325RL and Wildwood WBF325RL travel trailers because the tires may contact chassis components, causing tire failure.

    Product
    FOREST RIVER — FOREST RIVER SALEM, WILDWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V628000·2024-08-22

    Forest River trailer tires may contact the outrigger and fail

    Forest River is recalling certain 2024 Salem and Wildwood travel trailers because the tire may contact the outrigger, causing the tire to fail. 34 units are affected.

    Product
    FOREST RIVER — FOREST RIVER SALEM, WILDWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1712-2024·2024-08-21

    Green Peppers Recalled Due to Potential Listeria Contamination

    RS Hanline and Company Inc is recalling green peppers due to potential Listeria monocytogenes contamination. The recall affects peppers distributed across nine states.

    Product
    Green Peppers packaged as whole 10lb carton, whole 20lb carton, whole 5lb carton
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-1735-2024·2024-08-21

    Lunds & Byerlys Guacamole Dip Recalled for Listeria Risk

    Metro Produce Distributors is recalling 66 units of Lunds & Byerlys Pico de Gallo/Guacamole Dip distributed in Minnesota due to potential Listeria monocytogenes contamination. Consumers should not consume the product.

    Product
    Lunds & Byerlys Pico de Gallo / Guacamole Dip, Net Wt 18 oz (510g). UPC 0 72431-02993 6. Keep Refrigerated.
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·24V626000·2024-08-21

    Chevrolet Silverado rear bumper brackets may be insufficient for towing

    OEM Systems is recalling certain 2024 Chevrolet Silverado vehicles because the rear bumper mounting bracket may not be sufficient for towing, allowing a trailer to detach.

    Product
    CHEVROLET — CHEVROLET SILVERADO 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide