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.

14101–14125 of 29192

  • SevereFDA (Devices)·Z-2302-2018·2018-07-04

    Intersurgical Flexible Breathing Circuit Recall Due to Exhalation Port Blockage Risk

    Intersurgical Inc is recalling 1,340 Flexible Smoothbore Breathing Circuits because the tubing may block the exhalation port during assembly, posing a serious health risk to patients.

    Product
    Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-2300-2018·2018-07-04

    Philips OmniDiagnost-Eleva X-ray System Recalled Due to Table Rotation Hazard

    Philips is recalling 508 OmniDiagnost-Eleva X-ray systems because a broken actuator fixation can cause the table to rotate uncontrollably, posing a risk of injury.

    Product
    OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V439000·2018-06-28

    BMW Recalls 2018 X5 and X6 Models for Front Control Arm Defect

    BMW is recalling 2018 X5 and X6 vehicles because a front lower-left control arm pivot bolt may not be properly hardened, potentially causing the arm to break and increasing crash risk.

    Product
    BMW — BMW X6, X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0882-2018·2018-06-27

    ICU Medical Recalls Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 941,496 bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.

    Product
    0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2238-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling 11 trauma guide wires due to packaging defects that may compromise sterility, posing an infection risk.

    Product
    G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2234-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling 449 trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0884-2018·2018-06-27

    ICU Medical Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical Inc is recalling 0.9% Sodium Chloride Injection bags because they may leak, compromising sterility. The recall covers lots distributed nationwide and in Canada.

    Product
    0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2269-2018·2018-06-27

    Olympus JF-140F Duodenoscopes Recalled for New Reprocessing Procedures

    Olympus is recalling 994 JF-140F duodenoscopes nationwide to implement new reprocessing procedures following reported patient infections.

    Product
    Olympus JF-140F duodenoscopes (Model NumberJF-140F)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V435000·2018-06-27

    Altec Recalls 2017 Aerial Devices Due to Fastener Corrosion Risk

    Altec is recalling 153 2017 aerial devices because high-strength fasteners may corrode and fail, potentially causing the pedestal to separate from the vehicle.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2271-2018·2018-06-27

    CryoLife Recalls Cryovalve SG Pulmonary Human Heart Valve

    CryoLife, Inc. is recalling one unit of the Cryovalve SG Pulmonary Human Heart Valve because final autopsy and toxicology reports indicated the presence of morphine in the donor's urine.

    Product
    Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0881-2018·2018-06-27

    ICU Medical Recalls 0.45% Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical Inc. is recalling 88,960 bags of 0.45% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.

    Product
    0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2254-2018·2018-06-27

    Draeger Perseus A500 Anesthesia Machine Recalled for Hypoxic Mixture Risk

    Draeger Medical is recalling 33 Perseus A500 anesthesia machines because a fault could allow the device to deliver a hypoxic gas mixture to patients.

    Product
    Perseus A500 Anesthesia Machine; Cat. no. MK06000 Product V Product Usage: Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressuresupported spontaneous breathing, and spontaneous breathing. Perseus is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0885-2018·2018-06-27

    ICU Medical Recalls 5% Dextrose Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 5% Dextrose Injection bags because they may leak, compromising sterility. The recall covers 267,288 bags distributed nationwide and in Canada.

    Product
    5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0883-2018·2018-06-27

    ICU Medical Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 525,984 bags of 0.9% Sodium Chloride Injection due to potential leaks that compromise sterility. The product was distributed nationwide and in Canada.

    Product
    0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V433000·2018-06-26

    KME Predator Emergency Vehicles Recalled for Lifting Device Defect

    KME is recalling 13 Predator emergency vehicles because tip-mounted lifting devices do not meet safety load ratings, posing an injury risk.

    Product
    KME — KME PREDATOR, PREDATOR SS AERIAL, PREDATOR SS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·056-2018·2018-06-26

    Aunt Kitty's Recalls Canned Chicken Gravy Due to Processing Deviation

    Aunt Kitty's Foods Inc. is recalling approximately 10,805 pounds of canned chicken gravy products due to a possible processing deviation that may have led to underprocessing.

    Product
    Aunt Kitty's Foods Inc — Aunt Kitty's Foods Inc. Recalls Canned Chicken Products Due to Possible Processing Deviation
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·18V432000·2018-06-26

    Lexus Recalls Vehicles for Fuel Leak Fire Risk

    Toyota is recalling specific Lexus models because fuel pulsation dampers may crack and leak, increasing the risk of a fire.

    Product
    LEXUS — LEXUS GS 350, IS 350, IS 350C, GS HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V430000·2018-06-25

    Audi Recalls 2013-2015 S8 and A8 Models for Fuel Leak Risk

    Volkswagen Group of America is recalling 2013-2015 Audi S8 and A8 vehicles because a fuel supply line may leak, increasing fire risk.

    Product
    AUDI — AUDI A8, S8
    Category
    Vehicle
    Distribution
    Distributed nationwide