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.

3351–3375 of 29099

  • 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
  • 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 (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
  • SevereNHTSA·24V253000·2024-04-05

    Forest River Recalls Transit Buses Due to Unsecured Brake Lines

    Forest River Bus is recalling specific 2018-2024 transit bus models because unsecured brake lines may be damaged by the frame rail, increasing crash risk.

    Product
    STARCRAFT BUS — STARCRAFT BUS, ELDORADO, ELKHART SENATOR II, CANDIDATE II, ADVANTAGE, ALLSTAR MVP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V080000·2024-04-05

    Autocar Recalls 2023 Xpeditor and Xspotter Vehicles for Steering Defect

    Autocar is recalling 2023 Xpeditor and Xspotter vehicles because steering gears may have fewer recirculating balls than required, risking loss of steering control.

    Product
    AUTOCAR — AUTOCAR XSPOTTER, XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24181·2024-04-04

    BLACK+DECKER Garment Steamers Recalled Nationwide for Burn Hazard

    Empower Brands is recalling approximately 1.6 million BLACK+DECKER Model HGS011 Easy Garment Steamers because they can expel, spray, or leak hot water during use, causing burn injuries. Consumers should stop using the steamers immediately and contact the manufacturer for a full refund.

    Product
    BLACK+DECKER Model HGS011 Easy Garment Steamers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V252000·2024-04-04

    Terex Advance Recalls 2023 Commander Vehicles for Steering Defect

    Terex Advance is recalling 2023 Commander vehicles because steering components may not be installed correctly, increasing the risk of a crash.

    Product
    TEREX ADVANCE — TEREX ADVANCE COMMANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V248000·2024-04-03

    Aston Martin Recalls 2021 DBX Vehicles for Loose Driveline Fasteners

    Aston Martin is recalling 2021 DBX vehicles because loose fasteners on the front propeller shaft and differential may cause loss of front wheel drive or engine stall.

    Product
    ASTON MARTIN — ASTON MARTIN DBX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1382-2024·2024-04-03

    Surgical Tracecarts Recalled Due to Defective Foley Catheter Component

    DeRoyal Industries is recalling 134 GeoMed Custom Tracecarts distributed in Florida that contain a recalled Foley catheter component. Affected units carry specific lot numbers with expiration dates from February 2024 through May 2025.

    Product
    GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1327-2024·2024-04-03

    FDA Recalls Fresenius Catheter Extension Tubing Due to Chemical Leachables

    Fresenius Medical Care is recalling 105,700 stay-safe /Luer Catheter Extension 6 in devices nationwide due to chemical leachables identified in the peroxide cross-linked tubing. FDA classified this as a Class I recall.

    Product
    stay-safe /Luer Catheter Ext. 6 in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1325-2024·2024-04-03

    Stay-safe Luer Lock catheter extension recalled for chemical leachables

    Fresenius is recalling 663,221 stay-safe Luer Lock catheter extension units nationwide due to chemical leachables (NDL PCBAs) identified in the tubing.

    Product
    stay-safe /Luer Lock Catheter Ext. 12 in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1374-2024·2024-04-03

    Obsidio Conformable Embolic coils recalled for bowel-ischemia risk

    Boston Scientific recalled 985 Obsidio Conformable Embolic coils because using the aliquot delivery technique for lower GI bleeding poses a high risk of bowel ischemia requiring major surgery.

    Product
    Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1286-2024·2024-04-03

    Nimbus II Infusion Pump Systems Recalled for Multiple Potential Device Failures

    InfuTronix is recalling 52,328 Nimbus II Infusion Pump Systems due to potential failure modes including battery failure, system errors, drug product leakage, flow rate issues, and housing damage. The devices will no longer be available or supported after June 20, 2024.

    Product
    Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and components
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1285-2024·2024-04-03

    Nimbus Ambulatory Infusion Pump recalled due to multiple failure modes

    InfuTronix is recalling Nimbus Infusion Pump Systems (Nimbus Flex, Nimbus PainPro) due to potential battery failure, system errors, drug leakage, flow rate abnormalities, and housing damage. About 52,328 units are affected nationwide.

    Product
    Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1107-2024·2024-04-03

    Trader Joe's Roasted and Salted Cashews Recalled Due to Salmonella Risk

    Trader Joe's 50% Less Sodium Roasted & Salted Whole Cashews are being recalled due to potential Salmonella contamination. The recall affects 6,001 cases distributed in California, Washington, and Texas.

    Product
    Trader Joe's 50% Less Sodium Roasted & Salted Whole Cashews Net Wt. 15 oz (1 LB) 454g Dist. & Sold Exclusively By: Trader Joe's, Monrovia, CA 91016 Cashews Product of India and Vietnam
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1323-2024·2024-04-03

    Catheter Extension Tubing Recalled Due to Identified Leachable Substances

    Fresenius Medical Care is recalling 114,982 stay-safe Safe Lock Catheter Extensions due to peroxide cross-linked tubing leachables. Patients and healthcare providers are advised to discontinue use and contact the manufacturer for replacement.

    Product
    stay-safe /Safe Lock Catheter Ext. 12 in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1099-2024·2024-04-03

    Great Value Honey Roasted Cashews Recalled for Undeclared Milk and Coconut Allergens

    Great Value Honey Roasted Cashews (8.25 oz cans, UPC 0 78742 13334 8) are being recalled due to undeclared milk and coconut allergens on the packaging. Consumers with allergies to these ingredients should not consume the product.

    Product
    Great Value Honey Roasted Cashews, 8.25oz. plastic can, UPC 0 78742 13334 8
    Category
    Food
    Distribution
    30 states
  • SevereFDA (Drugs)·D-0429-2024·2024-04-03

    Treprostinil Injection recalled nationwide due to particulate matter contamination

    Par Pharmaceutical is recalling Treprostinil Injection nationwide due to the presence of particulate matter. This FDA Class I recall affects 466 vials of lot 57014 distributed throughout the United States.

    Product
    Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1326-2024·2024-04-03

    Catheter Extension Recalled by Fresenius Due to Chemical Leachables

    Fresenius is recalling 479,978 stay-safe Luer Lock Catheter Extensions due to chemical leachables in the tubing. Healthcare providers should contact the manufacturer for replacement information.

    Product
    stay-safe /Luer Lock Catheter Ext. 18 in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1324-2024·2024-04-03

    FDA Recalls stay-safe Luer Lock Adapter for Chemical Leachables

    The FDA is recalling approximately 828,954 stay-safe Luer Lock Adapters due to chemical leachables identified in the peroxide cross-linked tubing. The nationwide recall affects all lots of Model Number 050-95003.

    Product
    stay-safe /Luer Lock Adapter 4 in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1302-2024·2024-04-03

    Boston Scientific steerable sheath devices recalled due to manufacturing defect risk

    Boston Scientific is recalling 461 POLARSHEATH Steerable Sheath devices due to a manufacturing tooling error that may cause inner sheath delamination and potential fragment release during medical procedures.

    Product
    Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1128-2024·2024-04-03

    Roland Tahini Recalled Due to Potential Salmonella Contamination

    Roland Tahini 16 oz jars are being recalled due to potential Salmonella contamination. Consumers should not consume this product and should return it to the retailer or contact Roland Foods, LLC.

    Product
    Roland Tahini; 100% Ground Sesame Seeds; Net WT. 16 OZ. (1 LB.) 454g
    Category
    Food
    Distribution
    33 states
  • SevereFDA (Food)·F-1101-2024·2024-04-03

    Sunflour Bakery Banana Nut Sweet Bread Recalled for Undeclared Soy and Yellow #5

    Sunflour Bakery Banana Nut Sweet Bread is recalled due to undeclared soy (a major allergen) and undeclared Yellow #5. Consumers with soy allergies should not consume this product.

    Product
    Sunflour Bakery Banana Nut Sweet Bread, 16 oz, clear poly bag
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·24V245000·2024-04-02

    2021 Jayco Redhawk motorhomes recalled for power steering connection defect

    Certain 2021 Jayco Redhawk motorhomes have a defective power steering connection that can cause sudden loss of power steering and brake assist, increasing crash risk. Dealers will replace the defective parts free of charge.

    Product
    JAYCO — JAYCO, ENTEGRA GREYHAWK, ESTEEM, ODYSSEY, GREYHAWK PRESTIGE
    Category
    Vehicle
    Distribution
    Distributed nationwide