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.

15176–15200 of 29202

  • SevereFDA (Devices)·Z-0143-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 333 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0126-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility

    Exactech is recalling 57 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0072-2018·2017-11-29

    Spacelabs Arkon Anesthesia Workstation Recalled for Mechanical and Display Failures

    Spacelabs Healthcare is recalling 110 Arkon Anesthesia Workstations due to failures in ventilation, gas delivery, and display alarms.

    Product
    Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0144-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 317 Optetrak Offset Tibial Trays because a design incompatibility exists with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • SevereNHTSA·17V768000·2017-11-29

    Ford Recalls 2017 F-53 and F-59 Chassis for Brake Fluid Leak Risk

    Ford is recalling 2017 F-53 and F-59 chassis because missing plugs in the brake control unit may cause fluid leaks or air ingestion, increasing stopping distance.

    Product
    FORD — FORD F-59, F-53
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V766000·2017-11-29

    Volkswagen Recalls 2018 Atlas Vehicles Due to Fuel Tank Leak Risk

    Volkswagen is recalling 2018 Atlas vehicles because the fuel tank may have insufficient wall thickness, potentially causing a fuel leak and increasing fire risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0076-2018·2017-11-22

    Amneal Recalls Fosphenytoin Sodium Injection Due to Particulate Matter

    Amneal Pharmaceuticals is recalling 14,000 vials of Fosphenytoin Sodium Injection because of the presence of particulate matter.

    Product
    Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0080-2018·2017-11-22

    PharMEDium Recalls Hydromorphone Injection Due to Potency Failure

    PharMEDium Services is recalling 499 syringes of Hydromorphone HCl injection because the product failed potency specifications.

    Product
    Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Davis Ave Cleveland, MS 38732, NDC 61553-352-40
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0244-2018·2017-11-22

    Etai's Recalls Veggie Wrap and Caprese Panini for Undeclared Tree Nuts

    Etai's Food, Inc. is recalling specific lots of Veggie Wrap and Caprese Panini due to undeclared tree nuts, posing a risk to consumers with allergies.

    Product
    Veggie Wrap, Net Wt: 8 oz/227g, UPC 7 62089 10655 3, Etai's, individual plastic container, keep under refrigeration
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0254-2018·2017-11-22

    Meijer Recalls Vegetable Products Due to Listeria Contamination Risk

    Meijer Distribution is voluntarily recalling specific vegetable products, including a Fiesta Tray with Red Pepper Hummus, due to potential Listeria monocytogenes contamination.

    Product
    Vegetable products including: FIESTA TRAY WITH RED PEPPER HUMMUS
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0246-2018·2017-11-22

    Meijer Recalls Broccoli Florets Due to Listeria Contamination Risk

    Meijer is voluntarily recalling specific broccoli floret products due to potential Listeria monocytogenes contamination identified by a supplier.

    Product
    Vegetable products including: BROCCOLI FLORETS 3 LB BROCCOLI FLORETS LB BROCCOLI FLORETS PLU 4548 PRE-PACKAGED BROCCOLI FLORETS BROCCOLI FLORETS 3 LB BAG
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0081-2018·2017-11-22

    Llorens Pharmaceutical Recalls Urin D/S Tablets Due to Potency Issues

    Llorens Pharmaceutical Corp. is recalling Urin D/S Tablets because FDA analysis found the product to be out of specification for assay, resulting in subpotent or superpotent tablets.

    Product
    Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, Rx Only, 100-count bottle, Manufactured For: Llorens Pharmaceutical Corp., International Division, Miami, FL 33166. NDC: 54859-701-10
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0249-2018·2017-11-22

    Meijer Recalls Asparagus Products Due to Listeria Contamination Risk

    Meijer is voluntarily recalling asparagus products due to potential Listeria monocytogenes contamination identified by a supplier.

    Product
    Vegetable products including: ASPARAGUS SPEARS & ASPARAGUS SPEARS WITH GARLIC PARMESAN
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0256-2018·2017-11-22

    Meijer Recalls Vegetable Trays Due to Listeria Contamination Risk

    Meijer is voluntarily recalling Large, Medium, and Small Veggie Trays due to potential Listeria monocytogenes contamination from a supplier.

    Product
    Vegetable products including:Large Veggie Tray Medium Veggie Tray Small Veggie Tray
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0366-2018·2017-11-22

    CFS West BBQ Sauce Recalled for Undeclared Egg

    CFS West Holdings Inc is recalling BBQ Sauce packed for Carl's Jr. and Hardee's because it may contain undeclared egg.

    Product
    BBQ Sauce, 200/0.88 oz Net Wt 11 lbs, Packed exclusively for Carl's Jr. Restaurants LLC, Hardee's Restaurants LLC, Carpinteria, CA. Packed packaged in plastic cups.
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Food)·F-0255-2018·2017-11-22

    Meijer Recalls Vegetable Trays with Hummus Due to Listeria Risk

    Meijer is voluntarily recalling fresh vegetable trays with hummus due to potential Listeria monocytogenes contamination from a supplier.

    Product
    Vegetable products including: Fresh Vegetable Tray with HUMMUS
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·17V741000·2017-11-21

    Chrysler Recalls 2014 Models for Alternator Failure Risk

    Chrysler is recalling 17,116 2014 Dodge, Jeep, and Chrysler vehicles because the alternator may fail, causing the vehicle to stall without warning.

    Product
    JEEP — JEEP, CHRYSLER, DODGE GRAND CHEROKEE, 300, CHALLENGER, CHARGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V732000·2017-11-21

    Jeep Recalls 2018 Compass Models Due to Loose Air Bag Mounting Nuts

    Chrysler is recalling 2018 Jeep Compass vehicles because loose passenger air bag inflator nuts could become projectiles in a crash, posing a risk of serious injury or death.

    Product
    JEEP — JEEP COMPASS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·18044·2017-11-21

    Plycem Recalls Allura Decking Due to Fall and Injury Hazards

    Plycem is recalling Allura fiber cement decking and fascia because the materials can crack, causing consumers to fall through and suffer injuries.

    Product
    Allura decking
    Category
    Consumer Product
    Distribution
    Distributed nationwide