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.

1051–1075 of 4878

  • 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-1354-2024·2024-04-10

    Mojo 2 Full Face Non Vented Mask Recalled for Magnet Safety Concerns

    SleepNet Corporation is recalling Mojo 2 Full Face Non Vented Masks due to magnets in the device and updated contraindications and warnings. The recall affects 2,107 units distributed worldwide.

    Product
    Mojo 2 Full Face Non Vented Mask, All Sizes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1352-2024·2024-04-10

    Mojo Non Vented Full Face Mask warning updated for magnet hazard

    SleepNet is updating safety warnings and contraindications for its Mojo Non Vented Full Face Mask due to magnet content. All 11,874 affected units are subject to this warning update.

    Product
    Mojo Non Vented Full Face Mask with Headgear, All Sizes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V722000·2024-04-09

    2023 Western Star 49X Trucks Recalled Due to Tie Rod Defects

    Certain 2023 Western Star and Freightliner trucks are being recalled because tie rod clamps may be improperly heat-treated and crack, potentially causing loss of steering control.

    Product
    WESTERN STAR — 2023 WESTERN STAR 49X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V400000·2024-04-06

    2024 Kia EV9 recalled for inadequate crash protection headliner

    Kia is recalling certain 2024 EV9 vehicles because the headliner may not adequately protect passengers from impact in a crash. The defect increases injury risk during accidents.

    Product
    KIA — 2024 KIA EV9
    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·22V284000·2024-04-04

    2021 Jeep Grand Cherokee Recalled for Sticking EGR Valve

    Chrysler is recalling 2021 Jeep Grand Cherokee and Dodge Durango vehicles due to EGR valve defects that may cause loss of drive power and increase crash risk. Dealers will provide free replacement.

    Product
    JEEP — 2021 JEEP GRAND CHEROKEE
    Category
    Vehicle
    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 (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 (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 (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
  • SevereNHTSA·23V172000·2024-04-03

    2023 Cadillac XT6 Transmission Defect Recall for Half-Shaft Disengagement

    General Motors is recalling 2023 Cadillac XT6 and related vehicles due to a transmission defect. An incorrectly built sun gear can cause the half-shaft to disengage, risking loss of drive power or vehicle rollaway.

    Product
    CADILLAC — 2023 CADILLAC XT6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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
  • 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
  • SevereNHTSA·22V195000·2024-04-03

    2022 Keystone Travel Trailers Recalled for Improper Hitch Welds

    Keystone is recalling certain 2022 Bullet, Outback, and Passport travel trailers due to improper welds on the coupler hitch. The defect can cause the trailer to separate from the tow vehicle, increasing crash and injury risk.

    Product
    KEYSTONE — 2022 KEYSTONE BULLET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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 (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-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-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-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
    0 states
  • 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 (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 (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