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.

4351–4375 of 29102

  • SevereFDA (Food)·F-1544-2023·2023-09-27

    Dietary Supplement Capsules Recalled for Toxic Yellow Oleander Substitution

    OBC GROUP CORP is recalling NUT DIET MAX dietary supplement capsules due to substitution with toxic Yellow Oleander instead of the labeled ingredient Nuez de la India.

    Product
    NUT DIET MAX, Nuez de la India, Aleurites Moluccanus, 30 Capsules, 500mg Veggie Caps
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2528-2023·2023-09-27

    Intensive Care Ventilators Recalled Due to Capacitor Degradation Risk

    Hamilton Medical is recalling 12 intensive care ventilators (model Hamilton-MR1) due to degrading capacitors that may leak electrolyte, potentially causing ventilation interruption. The recall affects specific serial numbers across the US and Puerto Rico.

    Product
    Hamilton-MR1, REF: 161010, Intensive Care Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2529-2023·2023-09-27

    Ventilator Control Board Spare Parts Recalled Due to Electrical Short-Circuit Risk

    Hamilton Medical is recalling 6 control board spare parts for ventilators due to degrading capacitors that may leak electrolyte and cause electrical short circuits, potentially interrupting ventilation.

    Product
    Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2527-2023·2023-09-27

    Hamilton-T1 Ventilator Recall: Degrading Capacitors May Interrupt Ventilation

    Hamilton Medical recalls 1,216 Hamilton-T1 ventilators due to degrading capacitors on the control board that may leak electrolyte and interrupt ventilation. The recall affects units distributed nationwide in the US and Puerto Rico.

    Product
    Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2525-2023·2023-09-27

    Portable Intensive Care Ventilator Recalled for Degrading Capacitor Issue

    Hamilton Medical is recalling 164 Hamilton-C1 portable ventilators due to degrading capacitors that may leak electrolyte, causing electrical short circuits that could interrupt ventilation.

    Product
    Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V652000·2023-09-25

    Kia Recalls Multiple Models Due to Electrical Short Fire Risk

    Kia is recalling 1.7 million vehicles because an electrical short in the brake control unit may cause an engine compartment fire.

    Product
    KIA — KIA SORENTO, RIO, OPTIMA HYBRID, SOUL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·046-2023·2023-09-25

    USDA Recalls Ineligible Imported Pork Chicharrones from Honduras

    Del Valle Import and Export is recalling 1,271 pounds of pork chicharrones imported from Honduras, a country ineligible to export pork to the U.S.

    Product
    Del Valle Import and Export, LLC, Recalls Ineligible Pork Chicharrones Product Imported From Honduras
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·23V651000·2023-09-22

    Hyundai Recalls Multiple Models Due to ABS Module Fire Risk

    Hyundai is recalling over 1.6 million vehicles because a leaking ABS module may cause an engine compartment fire. Owners should park outside until the repair is complete.

    Product
    HYUNDAI — HYUNDAI ELANTRA, AZERA, SANTA FE, GENESIS COUPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V647000·2023-09-21

    2023 Subaru Driveshaft Center Support Bolts May Loosen

    Subaru is recalling certain 2023 Ascent, Legacy, Impreza, and Outback vehicles because center support bolts for the driveshaft may loosen, potentially causing the driveshaft to disconnect and increasing crash risk. Dealers will clean and replace the bolts at no charge.

    Product
    SUBARU — SUBARU OUTBACK, ASCENT, LEGACY, IMPREZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23294·2023-09-21

    Shimano 11-Speed Road Cranksets Recalled for Crash Hazard

    Shimano is recalling about 680,000 bonded 11-speed road cranksets because the crank parts can separate and break, posing a crash hazard. Six injuries including bone fractures have been reported.

    Product
    11-Speed Bonded Hollowtech II Road Cranksets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2507-2023·2023-09-20

    Abbott Proclaim Plus 5 Implantable Pulse Generator MRI Mode Exit Failure

    Abbott Medical is recalling Proclaim Plus 5 Implantable Pulse Generators (Model 3670) due to reports that patients are unable to exit MRI mode on the devices.

    Product
    Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2511-2023·2023-09-20

    Infinity 7 Implantable Pulse Generator Recall Due to MRI Mode Exit Failure

    Abbott Medical recalls Infinity 7 Implantable Pulse Generators due to reports that patients cannot exit MRI mode. The FDA has classified this as a Class I recall affecting devices distributed worldwide.

    Product
    Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2508-2023·2023-09-20

    Proclaim Plus 7 Implantable Pulse Generator Cannot Exit MRI Mode

    Abbott Medical recalled Proclaim Plus 7 Implantable Pulse Generators due to a defect preventing patients from exiting MRI mode. This operational failure could compromise device functionality during or after magnetic resonance imaging procedures.

    Product
    Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V642000·2023-09-20

    2023 Chevrolet Tahoe and Related Models Suspension Bolt Recall

    General Motors is recalling certain 2023 Tahoe, Suburban, Escalade, Escalade ESV, Yukon, and Yukon XL vehicles due to improperly heat-treated rear suspension bolts that may break, risking wheel misalignment and crash.

    Product
    CADILLAC — CADILLAC, CHEVROLET, GMC ESCALADE ESV, SUBURBAN, TAHOE, YUKON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1513-2023·2023-09-20

    Natural Products Supplement Recalled Due to Mislabeling with Toxic Plant

    Todorganic Inc. is recalling TODRGANIC Natural Products NUEZ DE LA INDIA (Lot 168, EXP 10/24) because the product contains Yellow Oleander instead of the labeled ingredient. Yellow Oleander is toxic if ingested.

    Product
    TODRGANIC Natural Products, NUEZ DE LA INDIA, Natural Products, 12 Seeds 12 Semillas
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2510-2023·2023-09-20

    Abbott Infinity 5 Implantable Pulse Generator Patients Unable to Exit MRI Mode

    Some Abbott Infinity 5 implantable pulse generator patients report being unable to exit MRI mode on their devices. This Class I recall affects 5,932 devices distributed globally.

    Product
    Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1495-2023·2023-09-20

    Zespri Organic Green Kiwi Recalled Due to Listeria Contamination

    Zespri Organic Green Kiwi from New Zealand has been recalled due to potential Listeria monocytogenes contamination. The recalled pallet was distributed across 14 U.S. states.

    Product
    Zespri Organic Green Kiwi, product of New Zealand, one pallet of bulk loose organic green kiwifruit was shipped to one consignee in Chicago, IL. The master carton has the barcode 067834 and the kiwi PLU label has the code GTIN 9400 9552.
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Devices)·Z-2514-2023·2023-09-20

    FDA Recalls Medline Hudson RCI Addipak Inhalation Solution for Sterility Failure

    Medline Industries is recalling HUDSON RCI Addipak 5mL sterile saline inhalation solution due to sterility failure. Approximately 18,000 units were distributed nationwide; the product was intended for scrap but was inadvertently shipped to customers.

    Product
    HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1494-2023·2023-09-20

    Zespri Organic Green Kiwi recalled for Listeria monocytogenes contamination

    Zespri Organic Green Kiwi from New Zealand is being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed across 14 states.

    Product
    Zespri Organic Green Kiwi, product of New Zealand, perishable, packaged in plastic clamshell, net wt. 1lb. UPC 818849020093. Distributed by The Oppenheimer Group, 180 Nickerson Street, Suite 211 Seattle WA. Zespri Organic Green Kiwi, product of New Zealand, perishable, packaged
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Devices)·Z-2506-2023·2023-09-20

    Proclaim XR 7 Implantable Pulse Generators unable to exit MRI mode

    Abbott Medical is recalling Proclaim XR 7 Implantable Pulse Generators due to a malfunction that prevents patients from exiting MRI (Magnetic Resonance Imaging) mode, potentially disrupting normal device operation and therapy delivery.

    Product
    Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1522-2023·2023-09-20

    Texas Tamale Company Black Bean Tamales Recalled for Undeclared Milk

    Texas Tamale Company is recalling Black Bean Tamales due to undeclared milk. The product poses a risk to consumers with milk allergies.

    Product
    Texas Tamale Black Bean Tamales 18 oz, (1 lb. 2 oz), 510 g
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2450-2023·2023-09-20

    Mallinckrodt One-Way Valve Recalled Due to Potential Oxygen Flow Failure

    Mallinckrodt Manufacturing is recalling approximately 13,600 One-Way Valves used with ventilators due to risk of valve sticking and oxygen flow reduction. The Class I recall affects worldwide distribution.

    Product
    Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2505-2023·2023-09-20

    Proclaim XR 5 Implantable Pulse Generators Cannot Exit MRI Mode

    Abbott Medical recalled the Proclaim XR 5 Implantable Pulse Generator after patients reported being unable to exit MRI mode on their devices. Approximately 113,784 units were distributed worldwide.

    Product
    Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes
    Category
    Medical Device
    Distribution
    Distributed nationwide