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.

1026–1050 of 4878

  • SevereFDA (Food)·F-1162-2024·2024-04-24

    H&NATURAL Brazil Seed supplement recalled for yellow oleander

    H&NATURAL Brazil Seed supplement is recalled due to the presence of yellow oleander, a toxic plant, in the product. No illnesses have been reported.

    Product
    H&NATURAL 2 PACK! BRAZIL SEED 60 PIECES, PURE NATURAL SEMILLA DE BRASIL FOR 60 DAYS, 5 GRAMS PER BOX, 2 ORANGE BOXES.
    Category
    Food
    Distribution
    0 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
  • SevereFDA (Food)·F-1171-2024·2024-04-24

    Herbal dietary supplement recalled for toxic yellow oleander presence

    HandNatural is recalling H&NATURAL BRAZIL SEED, a dietary supplement sold online, due to contamination with yellow oleander, a toxic plant component.

    Product
    H&NATURAL BRAZIL SEED 30 PIECES, PURE NATURAL SEMILLA DE BRASIL FOR 30 DAYS, 5 GRAMS PER BOX, BLACK BOX.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0442-2024·2024-04-24

    Vancomycin Hydrochloride Oral Solution Recalled Nationwide for Superpotency Due to Overfilling

    Amneal Pharmaceuticals is recalling Vancomycin Hydrochloride Oral Solution nationwide due to manufacturing overfilling causing superpotency with higher-than-labeled concentration. The FDA classified this as Class I.

    Product
    VANCOMYCIN HYDROCHLORIDE — VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
    Category
    Drug
    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
  • SevereFDA (Food)·F-1158-2024·2024-04-24

    H&Natural Tejocote Root Dietary Supplement Recalled Due to Yellow Oleander

    HandNatural is recalling H&Natural Tejocote Root dietary supplement because the product contains yellow oleander and its components, which pose a health risk.

    Product
    H&NATURAL TEJOCOTE ROOT Dietary Supplement Net WT 0.36 oz (10g)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1397-2024·2024-04-24

    Elekta Disposable Biopsy Needles Recalled for Microscopic Internal Debris

    Elekta recalled disposable biopsy needles from batch 837838839 that may contain microscopic stainless steel debris inside. The sterility of the needles has not been affected, and this issue has been reported from only one site.

    Product
    Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 91
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1166-2024·2024-04-24

    H&Natural Brazil Seed dietary supplement recalled for yellow oleander

    HandNatural is recalling H&Natural Brazil Seed 30-piece supplements due to the presence of yellow oleander and its components in the product. Consumers should stop using the product immediately and dispose of it safely.

    Product
    H&NATURAL BRAZIL SEED 30 PIECES, PURE NATURAL SEMILLA DE BRASIL FOR 30 DAYS, 5 GRAMS PER BOX, BLACK BOTTLE
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1168-2024·2024-04-24

    H&Natural Brazil Seed supplement recalled for toxic plant contamination

    HandNatural is recalling H&Natural Brazil Seed supplements because the product contains yellow oleander, a toxic plant that poses serious health risks. Consumers should stop using the product immediately.

    Product
    H&NATURAL BRAZIL SEED 30 PIECES, PURE NATURAL SEMILLA DE BRASIL FOR 30 DAYS, 5 GRAMS PER BOX, ORANGE BOX.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1499-2024·2024-04-24

    Philips Respironics Aeris EVO Ventilators Recalled for Loss of Ventilation Risk

    Philips Respironics is recalling Aeris EVO ventilators due to a software defect that may cause false battery or power alarms while the device retains adequate power, risking sudden loss of ventilation in pediatric and adult patients. Approximately 775 units are affected.

    Product
    Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1139-2024·2024-04-17

    Baked Mac and Cheese Recalled for Undeclared Egg Allergen and Missing Ingredients

    Robeson Enterprises is recalling 482 units of PIES & SIDES Baked Mac and Cheese because the label fails to declare egg as an allergen and does not list any ingredients. Products were distributed to Georgia, North Carolina, and South Carolina.

    Product
    PIES & SIDES BAKED MAC AND CHEESE, ALLERGENS: MILK, PIES & SIDES MOUNT HOLLY, NC
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0440-2024·2024-04-17

    FDA Class I Recall: Methocarbamol Injection for Particulate Matter

    Eugia US LLC is recalling Methocarbamol Injection nationwide due to particulate matter contamination. The FDA classified this as a Class I recall affecting lot 3MC23011 (expiration 11/30/2026).

    Product
    METHOCARBAMOL — METHOCARBAMOL (METHOCARBAMOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1136-2024·2024-04-17

    Deep South Tomato Pie Recalled for Undeclared Eggs

    Robeson Enterprises is recalling Deep South Tomato Pie because the label does not list sub-ingredients, and pimento cheese in the product may contain undeclared eggs. Consumers with egg allergies should not consume this product.

    Product
    PIES & SIDES DEEP SOUTH TOMATO PIE, INGREDIENTS: SLICED TOMATOES, PIMENTO CHEESE, BLEACHED FOUR, MILK PRODUCTS, SPICES. CONTAINS: SOY, FISH, WHEAT, MILK PIES & SIDES MOUNT HOLLY, NC
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1143-2024·2024-04-17

    Pumpkin Pie Recalled Due to Undeclared Milk and Egg Allergens

    Robeson Enterprises recalls PIES & SIDES brand pumpkin pie because the product label fails to list undeclared milk and eggs, posing a risk to consumers with these allergies.

    Product
    PIES & SIDES PUMPKIN PIE 10.5 oz INGREDIENTS: PUMPKIN FILLING, SUGARS, VANILLA, BLEACHED FLOUR, SPICES, CONTAINS: WHEAT PIES & SIDES MOUNT HOLLY, NC
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1484-2024·2024-04-17

    Ivenix Infusion System Software Recalled for Potential Dosing Anomalies

    Fresenius Kabi USA is recalling Ivenix Infusion System software version 5.8.0 for anomalies that could cause incorrect medication dosing or therapy delays. The Class I recall affects 17 units across 13 US states.

    Product
    LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Food)·F-1124-2024·2024-04-17

    Naturz Organics Pea Protein Recalled for Possible Salmonella Contamination

    Naturz Organics is recalling Organic Pea Protein (Item Code NO-OPP-80, 20 kg bags) due to possible salmonella contamination. The recall affects bulk product distributed to one consignee in Wisconsin.

    Product
    Naturz Organics Organic Pea Protein, Item Code NO-OPP-80, Net Weight 20 KG Bulk product packaged in paper bags.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1147-2024·2024-04-17

    Dietary supplement recalled for toxic yellow oleander substitution

    Alipotec Raiz de Tejocote dietary supplements are being recalled because they contain toxic yellow oleander instead of tejocote. All 280 bottles were distributed nationwide.

    Product
    Alipotec Raiz de Tejocote dietary supplements, Net. Wt. 0.35oz, plastic bottle labeled with the "Alipotec King" sticker. Store at room temperature.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereCPSC·24199·2024-04-11

    Zipline Kits Recalled Due to Cable-Breaking Fall Hazard

    Jugader Zipline Kits sold on Amazon.com from March 2020 through June 2023 are recalled because the stainless-steel cable can break, causing falls. The manufacturer has received 20 reports of cable breakage resulting in nine injuries.

    Product
    Zipline Kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·24743·2024-04-11

    Matrix T1 and T3 Commercial Treadmills Fire Hazard Expansion Recall

    Johnson Health Tech North America is expanding its recall of Matrix T1 and T3 Series commercial treadmills due to a fire hazard from loose power cords. About 9,700 additional units are affected.

    Product
    Matrix T1 and T3 Series Commercial Treadmills
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1356-2024·2024-04-10

    iQ 2 Nasal Vented Mask Recalled for Magnet Safety Warnings

    SleepNet Corporation is recalling the iQ 2 Nasal Vented Mask due to magnets requiring updated contraindication and warning language. Approximately 2,477 units distributed worldwide are affected.

    Product
    iQ 2 Nasal Vented Mask
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1116-2024·2024-04-10

    Dark Chocolate Cherry Granola Recalled Due to Undeclared Almond Allergen

    Kick Ash Products is recalling Dark Chocolate Cherry Granola because it contains undeclared almond, a common allergen. Affected products may be unsafe for individuals with almond allergies.

    Product
    Kick Ash Products, Door County Love Dark Chocolate Cherry Granola, 1lb, laminated resealable bag
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1353-2024·2024-04-10

    Mojo 2 Full Face Vented Mask Recalled: Magnet Contraindications Updated

    SleepNet Corporation is recalling 2,787 units of the Mojo 2 Full Face Vented Mask due to updates needed for contraindications and warning language regarding magnets in the device. Worldwide distribution.

    Product
    Mojo 2 Full Face Vented Mask, All Sizes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1351-2024·2024-04-10

    Mojo Full Face CPAP Mask Recall: Magnet Safety Update

    SleepNet Corporation is recalling 23,042 Mojo Full Face CPAP masks worldwide because the masks contain magnets that require updated contraindications and warning language.

    Product
    Mojo Full Face with Headgear, All Sizes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1355-2024·2024-04-10

    Mojo 2 CPAP Masks Recalled Worldwide for Magnet Safety Contraindication Update

    SleepNet Corporation is recalling Mojo 2 Full Face CPAP masks (1,268 units worldwide) to update contraindications and warning language due to magnets in the masks. The FDA classified this as a Class I recall.

    Product
    Mojo 2 Full Face AAV Non Vented Mask, All Sizes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1114-2024·2024-04-10

    Soy bean sprouts recalled for Listeria monocytogenes contamination

    Samsung Bean Sprout is recalling 500 bags of Sam Sung Soy Bean Sprouts with a sell-by date of December 21, 2023, distributed in Virginia, due to potential Listeria monocytogenes contamination.

    Product
    Soy Bean Sprouts in a package labeled in part: Sam Sung Soy Bean Sprouts, Net Wt. 1LB have a Sell By date of December 21, 2023.
    Category
    Food
    Distribution
    0 states