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.

1976–2000 of 29084

  • SevereFDA (Devices)·Z-1637-2025·2025-05-07

    GE Healthcare CARESTATION 750c A1 Anesthesia System Ventilation Defect

    GE Healthcare CARESTATION 750c A1 anesthesia systems may not provide effective ventilation in Volume Control Ventilation mode. Affected units can achieve ventilation through alternative modes or manual operation.

    Product
    GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1624-2025·2025-05-07

    GE Healthcare CARESTATION anesthesia systems ventilation malfunction recall

    GE Healthcare CARESTATION 620 A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Effective ventilation is available in Pressure Control or Manual ventilation modes.

    Product
    GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1699-2025·2025-05-07

    Distal Femoral Augment medical device recall for defective screw

    Waldemar Link GmbH & Co. KG is recalling Distal Femoral Augment devices because the preassembled femoral augment screw was missing its thread. The defect may affect proper device function.

    Product
    Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 - cemented sm), (6) 880-303/12 (Sz. 3-4 - cemented md), (7) 88
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1702-2025·2025-05-07

    Tibial Augment devices recalled for missing screw thread

    Waldemar Link GmbH & Co. KG is recalling Tibial Augment devices distributed nationwide because preassembled Femoral Augment screws were delivered missing their threads.

    Product
    Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - cemented x-lg), (6) 880-331/23 (Sz. 1-2 - cemented xx-lg), (7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1632-2025·2025-05-07

    GE Healthcare CARESTATION 650C A1 Anesthesia System Ventilation Recall

    GE Healthcare CARESTATION 650C A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Ventilation can be achieved using alternate modes or manual ventilation.

    Product
    GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1633-2025·2025-05-07

    GE Healthcare CARESTATION Anesthesia Systems Volume Control Ventilation Failure

    GE Healthcare CARESTATION anesthesia delivery systems may fail to provide effective ventilation in Volume Control Ventilation mode. Affected units can deliver ventilation through Pressure Control Ventilation modes or manual ventilation.

    Product
    GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1634-2025·2025-05-07

    GE Healthcare Carestation 650c A1 Anesthesia System Ventilation Failure

    GE Healthcare is recalling certain Carestation 650c A1 anesthesia systems worldwide because they may not provide effective ventilation in Volume Control Ventilation mode, limiting patient ventilation options during anesthesia delivery.

    Product
    GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1628-2025·2025-05-07

    GE Healthcare Carestation 650 A1 Anesthesia System Ventilation

    Certain GE Healthcare Carestation 650 A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Alternative ventilation modes or manual ventilation can be used.

    Product
    GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1636-2025·2025-05-07

    GE Healthcare CARESTATION Anesthesia Systems Ventilation Mode Failure Recall

    Certain GE Healthcare CARESTATION 750 A2 anesthesia systems may not provide effective ventilation in Volume Control Ventilation mode. Users should switch to Pressure Control Ventilation or Manual ventilation modes.

    Product
    GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1700-2025·2025-05-07

    Posterior Femoral Augment with Missing Screw Thread Recalled

    Waldemar Link is recalling Posterior Femoral Augments used in knee surgery because some units were delivered with a preassembled screw missing its thread, which could compromise surgical fixation.

    Product
    Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) 880-313/11 (Sz. 3-4 - cemented sm), (6) 880-313/12 (Sz. 3-4 - cemented md), (7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1627-2025·2025-05-07

    GE Healthcare Anesthesia Systems Recalled Over Ventilation Failure

    GE Healthcare is recalling certain Carestation 620/650/650c and 750/750c anesthesia delivery systems because they may not provide effective ventilation in Volume Control Ventilation (VCV) mode. The issue does not affect Pressure Control Ventilation (PCV), PCV-VG, or manual ventilation modes.

    Product
    GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V291000·2025-05-06

    2025 Hyundai Palisade vehicles recalled for electric oil pump fire risk

    Hyundai is recalling certain 2025 Palisade vehicles because an insufficient seal on the electric oil pump controller can allow moisture to accumulate and cause an electrical short that may result in fire. Owners should park vehicles outside and away from structures until the repair is completed.

    Product
    HYUNDAI — HYUNDAI PALISADE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·014-2025·2025-05-02

    Ferrarini USA Recalls Ready-to-Eat Prosciutto for Import Violation

    Ferrarini USA is recalling approximately 70 pounds of ready-to-eat sliced prosciutto imported without required reinspection. No illnesses have been reported.

    Product
    Ferrarini USA, Inc., Recalls Ready-to-Eat Prosciutto Products Imported Without Benefit of Import Reinspection
    Category
    Food
    Distribution
    1 state
  • SevereCPSC·25248·2025-05-01

    Baseus 65W Portable Chargers Recalled Due to Fire Hazard

    Baseus 65W 30000mAh portable chargers (model BS-30KP365) are being recalled because the lithium-ion battery can overheat and catch fire. The manufacturer has received 76 reports of incidents, including 4 fires and 3 reports of property damage.

    Product
    Baseus 65W 30000mAh Portable Chargers (model number BS-30KP365)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·25247·2025-05-01

    SharkNinja Foodi Multi-Function Pressure Cookers Recalled for Burn Hazard

    SharkNinja is recalling about 1.8 million Foodi OP300 Series pressure cookers because the pressure-cooking lid can open during use, causing hot contents to escape and burn injuries. The company has received 106 reports of burn injuries, including more than 50 second- or third-degree burns.

    Product
    SharkNinja Foodi OP300 Series Multi-Function Pressure Cookers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0373-2025·2025-04-30

    Ketamine HCl Syringes Recalled for Lack of Sterility Assurance

    Denver Solutions, LLC is recalling Ketamine HCl 50mg per 5mL single-dose syringes nationwide due to leaking or damaged syringes that may lack sterility assurance. Two affected lots are identified with expiration dates in July 2025.

    Product
    Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0371-2025·2025-04-30

    Dexmedetomidine HCl Syringes Recalled for Potential Sterility Issue

    Leiters Health is recalling dexmedetomidine HCl PF syringes nationwide due to leaking or damaged syringes that may not maintain sterility. Affected lot 2431276A has an expiration date of 4/20/2025.

    Product
    dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0721-2025·2025-04-30

    Zaarah Herbals Bhringraj Powder Recalled for Elevated Lead and Arsenic

    Zaarah Herbals brand Bhringraj Powder contains elevated levels of lead and arsenic. Consumers should not use the product and should contact the recalling firm for instructions.

    Product
    Zaarah Herbals brand Bhringraj Powder; packaged in 100g clear jars with gold lids; UPC: 6 35028 99973 1
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0730-2025·2025-04-30

    Walker's Wine Juice Pumpkin Juice recalled for potential botulinum contamination

    Walker's Wine Juice Pumpkin Juice in 2.5, 5, 30, 60, and 275 gallon bulk containers is being recalled due to potential contamination with Clostridium botulinum. The product was distributed across multiple states.

    Product
    Walker's Wine Juice Pumpkin Juice 2.5, 5, 30, 60, 275 gallon bulk containers
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Food)·F-0724-2025·2025-04-30

    Zaarah Herbals Rasayan Churan Recalled for Elevated Lead Levels

    Zaarah Herbals brand Rasayan Churan (100g jars) is recalled due to elevated lead levels of 88.038 ppm. The product was distributed in New York, Connecticut, New Jersey, and California.

    Product
    Zaarah Herbals brand Rasayan Churan; packaged in 100g clear jars with gold lids; UPC:6 35028 99966 3
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0367-2025·2025-04-30

    Haloperidol Decanoate Injection Recalled Due to Sterility Concerns

    Amerisource Health Services LLC is recalling Haloperidol Decanoate Injection due to lack of assurance of sterility and bacterial contamination detected in some media fill units. The drug is used for intramuscular injection to treat psychiatric conditions.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0369-2025·2025-04-30

    Haloperidol Decanoate Injection Recalled Due to Sterility Concerns

    Amerisource Health Services LLC is recalling Haloperidol Decanoate Injection vials nationwide because some media fill units showed bacterial contamination, indicating a lack of sterility assurance. The affected product is a 100mg/mL injectable antipsychotic medication.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0368-2025·2025-04-30

    Haloperidol Decanoate Injection Recalled for Lack of Sterility Assurance

    Amerisource Health Services LLC is recalling Haloperidol Decanoate Injection due to lack of assurance of sterility and bacterial contamination detected in some media fill units. The affected product was distributed nationwide.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide