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.

3276–3300 of 29099

  • 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 (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 (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 (Drugs)·D-0456-2024·2024-05-01

    The GOAT Sublingual Strip Recalled for Undeclared Prescription Drug Ingredients

    The GOAT Sublingual Strip male enhancement product, distributed nationwide, was recalled for containing undeclared sildenafil and tadalafil. The product was marketed without FDA approval.

    Product
    The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres LLC, 130 Maccormick Ave, Suite 105, Costa Mesa, A, UPC 6 61631 26363 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (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 (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 (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-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 (Devices)·Z-1613-2024·2024-05-01

    Route 92 Medical delivery catheter recalled due to tip separation risk

    Route 92 Medical is recalling Tenzing 7 delivery catheters because the distal tip may separate from the proximal marker band. The affected units were distributed across the US and New Zealand.

    Product
    Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
    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
  • SevereNHTSA·24V307000·2024-04-30

    Braun Ambulances Recalls 2023-2024 Models Due to Electrical Fire Risk

    Braun Ambulances is recalling 29 vehicles from 2023-2024 because a firmware defect can cause electrical circuits to overheat, increasing the risk of fire.

    Product
    BRAUN AMBULANCES — BRAUN AMBULANCES EXPRESS PLUS TYPE I, CHIEF XL TYPE I, EXPRESS TYPE III, CHIEF XL TYPE III
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V306000·2024-04-30

    Alfa Romeo Giulia Fuel Line Sensor Housing Recall

    Stellantis is recalling 2021 Alfa Romeo Giulia vehicles because a fuel line sensor housing may crack and leak fuel, increasing the risk of engine stall or fire.

    Product
    ALFA ROMEO — ALFA ROMEO GIULIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V304000·2024-04-29

    Nissan Sentra driveshaft may unseat causing fluid leak and power loss

    Nissan is recalling certain 2024 Sentra vehicles because the front left driveshaft may not be fully seated in the CVT assembly, or may have a loose or missing retaining clip.

    Product
    NISSAN — NISSAN SENTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V302000·2024-04-29

    MINI Cooper SE battery housing can admit water causing fire or stall

    BMW is recalling certain 2020-2024 MINI Hardtop 2 Door (Cooper SE) vehicles because the high voltage battery housing may not have been sealed properly, allowing water to enter the battery.

    Product
    MINI — MINI COOPER SE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V298000·2024-04-26

    Mercedes-Benz Recalls ML, GL, and R-Class Vehicles for Brake Booster Defect

    Mercedes-Benz is recalling 2006-2012 ML, GL, and R-Class vehicles because moisture in the brake booster can cause corrosion and brake failure.

    Product
    MERCEDES BENZ — MERCEDES BENZ, MERCEDES-BENZ ML550, R320, AMG ML63, ML320
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V297000·2024-04-26

    Micro Bird Recalls G5 School Buses for Brake and Steering Fluid Leak

    Micro Bird is recalling 2019-2022 G5 school buses because a faulty connection may cause a loss of power steering and brake assist, increasing crash risk.

    Product
    MICRO BIRD — MICRO BIRD G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1159-2024·2024-04-24

    HandNatural Brazil Seeds Recalled for Toxic Yellow Oleander Contamination

    HandNatural Brazil seeds (5g) have been recalled for contamination with yellow oleander, a highly toxic substance. FDA classified this as a Class I recall due to serious health hazards.

    Product
    Brazil Seed Net WT 0.18 oz (5g)
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·24V288000·2024-04-24

    BMW Recalls 2014-2015 Models for Head Air Bag Inflator Defect

    BMW is recalling 2014-2015 2, 3, and 4 Series vehicles because head air bag inflators may fail, posing an injury risk.

    Product
    BMW — BMW 328D, 335I, 228I, 328I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1503-2024·2024-04-24

    Trilogy Evo O2 Ventilator Recalled for Potential Sudden Loss of Ventilation

    Philips Respironics is recalling 789 Trilogy Evo O2 ventilators due to a software defect that can trigger a false power alarm despite sufficient power, potentially causing sudden loss of ventilation in pediatric and adult patients.

    Product
    Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·014-2024·2024-04-24

    ConSup Recalls Ready-to-Eat Sliced Prosciutto Produced Without Inspection

    ConSup North America Inc. is recalling approximately 85,984 pounds of ready-to-eat sliced prosciutto produced in Germany without the benefit of equivalent inspection.

    Product
    ConSup North America Inc. Recalls Ready-To-Eat Sliced Prosciutto Product Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-1512-2024·2024-04-24

    Dräger Perseus A500 Anesthesia Workstation Recalled for Unexpected Battery-Power Shutdowns

    Draeger Medical is recalling approximately 16,841 Dräger Perseus A500 Anesthesia Workstations due to unexpected shutdown while operating on battery power. The devices have been distributed nationwide and internationally.

    Product
    Dr¿ger Perseus A500 Anesthesia Workstation
    Category
    Medical Device
    Distribution
    Distributed nationwide