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.

976–1000 of 4878

  • SevereFDA (Devices)·Z-1609-2024·2024-05-15

    Insulin pump app may crash and drain battery, risking insulin delivery interruption

    Tandem's t:connect app version 2.7+ may crash repeatedly, draining the insulin pump battery faster than expected and potentially interrupting insulin delivery.

    Product
    t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V832000·2024-05-11

    2024 Tesla Cybertruck drive inverter fault may cause power loss

    Tesla is recalling 2024 Cybertruck vehicles due to a drive inverter fault that may cause loss of propulsion. Affected owners will receive a free inverter replacement.

    Product
    TESLA — 2024 TESLA CYBERTRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V836000·2024-05-11

    2024-2025 Lucid Air vehicles recalled for wiring harness defect

    Lucid is recalling 2024-2025 Air models due to a rear subframe wiring harness that may be too short, causing power loss to the rear drive unit and increasing crash risk. Replacement is free.

    Product
    LUCID — 2025 LUCID AIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V697000·2024-05-10

    Proterra Transit Buses Recalled for Inverter Power Loss Risk

    Proterra is recalling 2019-2022 ZX5 and Catalyst 800V transit buses due to inverter transistor overheating risk. A transistor failure can cause loss of power steering and drive power, increasing crash risk.

    Product
    PROTERRA — 2021 PROTERRA ZX5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V653000·2024-05-09

    RAM 1500 Models Recalled for Anti-Lock Brake Software Malfunction

    Chrysler is recalling certain 2019, 2021-2024 RAM 1500 vehicles because a software malfunction in the ABS control module may disable the electronic stability control system, increasing crash risk.

    Product
    RAM — 2024 RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1693-2024·2024-05-08

    Thoratec HeartMate 3 Left Ventricle Assist System Recalled for Seal Leak

    Thoratec recalls HeartMate 3 left ventricle assist systems due to potential leaks at the seal interface. The FDA Class I recall affects 659 implanted devices worldwide.

    Product
    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1238-2024·2024-05-08

    King Kullen Broccoli Cutlets Recalled for Undeclared Wheat and Sesame

    King Kullen Broccoli Cutlets with Breadcrumbs and Parmesan are being recalled because they contain undeclared wheat and sesame, which can cause allergic reactions in sensitive consumers.

    Product
    King Kullen Broccoli Cutlets with Breadcrumbs and Parmesan; 20oz; oven safe tin package with a clear dome top marked with a UPC Code 0 8531610145 0
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·23V588000·2024-05-08

    2023 Honda Accord and CR-V Hybrid transmission defect can cause power loss

    Honda is recalling certain 2023 Accord Hybrid and CR-V Hybrid vehicles because the electronic continuously variable transmission (e-CVT) may have been improperly manufactured, potentially resulting in loss of drive power and increased crash risk.

    Product
    HONDA — 2023 HONDA ACCORD HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V408000·2024-05-06

    Rivian R1S and R1T damaged pillar clips affect airbag deployment

    Rivian is recalling certain 2022-2024 R1S and R1T vehicles. Damaged attachment clips on pillar trim panels may prevent proper side curtain airbag deployment in a crash, increasing injury risk.

    Product
    RIVIAN — 2023 RIVIAN R1S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V407000·2024-05-06

    2023 Kia Telluride power seat motor fire risk recall

    Kia is recalling certain 2023 Telluride vehicles due to a fire risk in the front power seat motor caused by a stuck seat slide knob. Owners should park outside until repairs are completed.

    Product
    KIA — 2023 KIA TELLURIDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V412000·2024-05-06

    2024 Hyundai Tucson and Santa Cruz power steering defect recall

    Hyundai is recalling 2024 Tucson and Santa Cruz vehicles due to a potential circuit board short in the power steering system. Loss of steering assist could increase crash risk.

    Product
    HYUNDAI — 2024 HYUNDAI TUCSON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24219·2024-05-02

    True Manufacturing Commercial Refrigerators with Secop Compressors Fire Hazard

    True Manufacturing is recalling about 29,200 commercial refrigerators equipped with Secop compressors that can overheat and catch fire. The firm has received 14 reports of fires causing property damage, with no injuries reported.

    Product
    Commercial Refrigerators with Secop Compressors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1614-2024·2024-05-01

    Route 92 Medical Reperfusion System Recalled for Potential Device Separation

    Nineteen units of the Route 92 Medical 070 Reperfusion System may experience distal tip separation. Healthcare facilities should cease use of affected devices immediately.

    Product
    Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.
    Category
    Medical Device
    Distribution
    30 states
  • SevereFDA (Devices)·Z-1610-2024·2024-05-01

    Route 92 Medical Access System Recalled for Distal Tip Separation

    Route 92 Medical's Full Length 070 Access System (REF 7002) is recalled due to potential distal tip separation at the proximal marker band of the delivery catheters. This FDA Class I recall affects a device used in neurovasculature interventions distributed across the US and New Zealand.

    Product
    Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
    Category
    Medical Device
    Distribution
    30 states
  • SevereFDA (Drugs)·D-0448-2024·2024-05-01

    Spanish Fly 22K Capsules Recalled for Undeclared Prescription Drug Ingredients

    Spanish Fly 22K capsules contain undeclared sildenafil and/or tadalafil and were marketed without FDA approval. The product poses serious health risks from these unapproved pharmaceutical ingredients.

    Product
    Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0470-2024·2024-05-01

    ForeverMen Natural Energy Boost Capsules Recalled for Undeclared Sildenafil

    ForeverMen Natural Energy Boost Capsules contain undeclared sildenafil and are marketed without FDA approval, making them an unapproved drug. Consumers should stop using the product immediately.

    Product
    ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0458-2024·2024-05-01

    Sexual Enhancement Product Recalled for Undeclared Prescription Drugs

    Pyramids Wholesale Inc. is recalling HONEY MANUKA BUNNY LOVE nationwide because it contains undeclared sildenafil and/or tadalafil—prescription medications—and was marketed without FDA approval.

    Product
    HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0449-2024·2024-05-01

    Honey product recalled nationwide for undeclared sildenafil and tadalafil

    Pyramids Wholesale Inc. is recalling Weiner Boner Honey due to undeclared sildenafil and tadalafil. The product was distributed nationwide without FDA approval.

    Product
    Weiner Boner Honey, 12g packet, 100% Organic Formula.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0460-2024·2024-05-01

    FDA Recalls Aruba Aloe Hand Sanitizer for Methanol Contamination

    FDA is recalling 5,299 bottles of Aruba Aloe Hand Sanitizer Gel nationwide due to methanol contamination in the ethanol ingredient. Consumers should stop using the product immediately.

    Product
    Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. UPC 0 82252 03300 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0453-2024·2024-05-01

    Male Sexual Enhancement Product Recalled for Undeclared Pharmaceutical Ingredients

    Pyramids Wholesale Inc. is recalling all lots of GoHARD 25000 because it contains undeclared sildenafil and tadalafil. The product was marketed without FDA approval for these prescription-strength drugs.

    Product
    GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1464-2024·2024-05-01

    VITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk

    Biomerieux Inc is recalling VITEK 2 AST test kits due to ceftriaxone concentration errors that could produce false susceptible results in antimicrobial susceptibility testing.

    Product
    VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491;
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0452-2024·2024-05-01

    Pink Pussycat Honey recalled for undeclared sildenafil and tadalafil content

    Pyramids Wholesale Inc. is recalling Pink Pussycat Honey because it contains undeclared sildenafil and tadalafil and was marketed without FDA approval. The recall affects all lots nationwide.

    Product
    Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1204-2024·2024-05-01

    Roly Poly Bakery Multigrain Bread Recalled for Undeclared Egg

    Roly Poly Bakery is recalling multigrain bread sold in Connecticut and Massachusetts because it contains undeclared egg, a major food allergen. Consumers with egg allergies should not consume this product.

    Product
    Roly Poly Bakery brand MULTIGRAIN bread; INGREDIENTS: Whole Wheat Flour, High Gluten Flour, Ryechops, Sesame, Caraway, Brownflex, Soybean, Pearl Wheat, Sunflower, Salt, Water.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0454-2024·2024-05-01

    FDA Recalls libigrow RED DRAGON+ Capsules for Undeclared Sildenafil and Tadalafil

    Pyramids Wholesale Inc. is recalling libigrow RED DRAGON+ capsules nationwide because they contain undeclared sildenafil and tadalafil, prescription medications not approved by the FDA for this product.

    Product
    libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1611-2024·2024-05-01

    Route 92 Medical Reperfusion System Potential Catheter Tip Separation

    Route 92 Medical recalls its Full Length 070 Reperfusion System due to potential distal tip separation at the proximal marker band, which could affect device delivery during interventional procedures.

    Product
    Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
    Category
    Medical Device
    Distribution
    30 states