The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. 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.

676–700 of 32246

  • SevereFDA (Devices)·Z-2548-2026·2026-07-08

    Hillrom VOLARA System P.CIRCUIT KIT Medical Device Recall for Oxygen Drop Risk

    Baxter Healthcare is recalling the Hillrom VOLARA System P.CIRCUIT KIT (Model REF M08085) due to reports of air and medication leakage from the nebulizer cup, which can cause oxygen level drops and reduce treatment effectiveness.

    Product
    Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2551-2026·2026-07-08

    Hillrom VOLARA System patient circuits recalled for nebulizer cup leakage

    Baxter Healthcare is recalling Hillrom VOLARA System patient circuits due to reports of air and medication leakage from the nebulizer cup, which can cause oxygen level drops and ineffective medication delivery.

    Product
    Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-1137-2026·2026-07-08

    NARA ORGANICS Whole Milk Organic Infant Formula Recalled for Botulinum Contamination

    NARA ORGANICS Whole Milk Organic Infant Formula in 24.7 oz and 14.1 oz sizes is being recalled nationwide because the product may be contaminated with Clostridium botulinum.

    Product
    a.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 24.7 OZ (700 G); UPC: 860013251901 b.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 14.1 OZ (400 G); UPC…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2644-2026·2026-07-08

    Cyberknife Treatment Delivery System Collimator Docking and Fall Hazard Recall

    Accuray Incorporated is recalling Cyberknife Treatment Delivery Systems with the Xchange Robotic Collimator Changer because a collimator may fail to fully dock and fall from the housing if room-control pendant motion is initiated while the system interlock is bypassed.

    Product
    Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2632-2026·2026-07-08

    CRE Wireguided 6-8mm 240cm Medical Device Recall Worldwide

    Boston Scientific Corporation is recalling the CRE Wireguided 6-8mm 240cm device worldwide due to a potential sterile breach of the packaging pouches.

    Product
    CRE Wireguided 6-8mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2634-2026·2026-07-08

    Boston Scientific CRE Wireguided Medical Device Recall Sterile Breach

    Boston Scientific is recalling CRE Wireguided 10-12mm 240cm medical devices due to a potential sterile breach in the product packaging. The breach could compromise device sterility and affect patient safety.

    Product
    CRE Wireguided 10-12mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0652-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled for Lack of Sterile Assurance

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, creating a lack of assurance of sterility.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V441000·2026-07-08

    BMW Recalls 29,119 Vehicles Due to Starter Relay Fire Risk

    BMW is recalling 29,119 vehicles because a corroded starter relay may overheat and short circuit, increasing the risk of a fire.

    Product
    BMW — BMW 530E XDRIVE IPERFORMANCE, 740LE XDRIVE IPERFORMANCE, 530E IPERFORMANCE, 330E IPERFORMANCE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0651-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Loss

    CareFusion 213, LLC is recalling ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol applicators distributed nationwide because unsterilized units intended for further processing were distributed through the wrong channels.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0647-2026·2026-07-08

    ChloraPrep One-Step Antiseptic Applicators Distributed Without Sterilization

    CareFusion 213, LLC is recalling 7,650 units of ChloraPrep One-Step antiseptic applicators distributed nationwide because unsterilized product intended for further processing was distributed through incorrect channels.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V434000·2026-07-07

    Braun Recalls 2026 Chevrolet Traverse Vehicles Due to Fuel Leak Risk

    Braun is recalling 2026 Chevrolet Traverse vehicles because a missing braze connection on the fuel fill line may allow fuel to leak, increasing the risk of fire.

    Product
    BRAUN — BRAUN CHEVROLET TRAVERSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V435000·2026-07-07

    Wabash Recalls Econex Refrigerated Bodies Due to Detaching Steps

    Wabash is recalling 2021-2026 Econex Refrigerated Bodies because side door stirrup steps may detach, increasing the risk of injury or a crash.

    Product
    WABASH — WABASH ECONEX REFRIGERATED BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·26601·2026-07-02

    Metal Wire Bristle Grill Brushes Recalled Over Detachable Bristle Ingestion Hazard

    Conair is recalling about 1.7 million Cuisinart metal wire bristle grill brushes because small wire bristles can detach and be swallowed, posing a risk of serious internal injury. Three consumers have already swallowed bristles and required medical treatment.

    Product
    Metal Wire Bristle Grill Brushes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·26593·2026-07-02

    CVS Health Medicated Hemorrhoidal Wipes Lack Child-Resistant Packaging

    CVS Health Medicated Hemorrhoidal Wipes lack required child-resistant packaging despite containing lidocaine, a substance that poses risk of serious injury or death if ingested by young children.

    Product
    CVS Health Medicated Hemorrhoidal Wipes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·26591·2026-07-02

    VEVOR Baby Loungers Recalled for Entrapment and Fall Hazards

    VEVOR baby loungers sold through multiple retailers from November 2024 through January 2026 are being recalled due to violations of mandatory infant sleep product safety standards. The loungers pose serious risks of fall and entrapment hazards that can cause death or serious injury.

    Product
    VEVOR baby loungers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V426000·2026-07-02

    Jayco Recalls 2026 Seismic Fifth Wheel Toy Haulers Due to Fire Risk

    Jayco is recalling 2026 Seismic fifth wheel toy haulers because the inverter may lack a grounding connection, increasing the risk of fire and electrical shock.

    Product
    JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL SEISMIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·26599·2026-07-02

    Metalux Optimized High Bay LED Light Fixtures Recalled for Fire Hazard

    Cooper Lighting recalls about 42,000 Metalux Optimized High Bay LED light fixtures due to a fire hazard. The LED board can overheat or contact combustible materials; nine fires have been reported with no injuries or property damage.

    Product
    Metalux Optimized High Bay (OHB) LED Light Fixtures
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V431000·2026-07-02

    Kia Recalls EV6 and EV9 Models Due to Battery Fire Risk

    Kia is recalling 2022-2024 EV6 and 2024 EV9 vehicles because high voltage battery cells may contain misaligned electrodes, creating a fire hazard.

    Product
    KIA — KIA EV9, EV6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V432000·2026-07-02

    Hyundai Recalls 2023-2024 Ioniq 5 Vehicles Due to Battery Fire Risk

    Hyundai is recalling 2023-2024 Ioniq 5 vehicles because high voltage battery cells may contain misaligned electrodes, posing a fire risk while parked or driving.

    Product
    HYUNDAI — HYUNDAI IONIQ 5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-1094-2026·2026-07-01

    Joy Saffron Cardamom Lassi recalled for inadequate pasteurization

    Joy Saffron Cardamom Lassi 16 oz. is being recalled because it was not adequately pasteurized. The product was distributed in New York, New Jersey, and Pennsylvania.

    Product
    Joy Saffron Cardamon Lassi 16 oz.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0623-2026·2026-07-01

    ChloraPrep One-Step Topical Solution Sterility Assurance Recall

    CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) due to wrinkles in the paper lidding that may breach the seal, compromising sterility assurance.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2521-2026·2026-07-01

    Da Vinci surgical system operative components with E-brake retainer pin defect

    Intuitive Surgical recalls certain Da Vinci surgical system operative components due to a defective E-brake retainer pin that may fail to engage the E-brake, potentially causing uncontrolled motion and patient injury.

    Product
    Da Vinci ASSY, PSS, SP1098, Part Number: 380601
    Category
    Medical Device
    Distribution
    Distributed nationwide