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.

24801–24825 of 32193

  • SevereFDA (Devices)·Z-2620-2014·2014-10-01

    ICU Medical Recalls STAT 2 Flow Controllers Due to High Flow Rate Risk

    ICU Medical is recalling STAT 2 Flow Controllers because they may deliver a significantly higher flow rate than intended.

    Product
    STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V615000·2014-10-01

    Entegra Aspire and Anthem Motorhomes Recalled for Fuel Filter Defect

    Entegra is recalling 2015 Aspire and Anthem motorhomes because a fuel filter defect may cause the engine to stall without warning, increasing crash risk.

    Product
    ENTEGRA — ENTEGRA ASPIRE, ANTHEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2702-2014·2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leaks

    Vapotherm is recalling 387 Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2622-2014·2014-10-01

    ICU Medical Recalls Stat 2 Flow Controllers Due to Flow Rate Issues

    ICU Medical is recalling specific IV administration sets because the Stat 2 flow controller may deliver a significantly higher flow rate than intended.

    Product
    98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2593-2014·2014-10-01

    CareFusion EnVe and ReVel Ventilators Recalled for Power Connector Damage Risk

    CareFusion is recalling 1,729 EnVe and ReVel ventilators because operator misconnection can damage the power connector, potentially shorting the power adapter.

    Product
    CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2619-2014·2014-10-01

    ICU Medical Recalls STAT 2 Flow Controllers Due to High Flow Rate

    ICU Medical is recalling STAT 2 Flow Controllers because they may deliver a significantly higher flow rate than intended.

    Product
    STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2707-2014·2014-10-01

    Spacelabs Patient Monitor Recall for Missing Audible Alarms in End Case Mode

    Spacelabs Healthcare is recalling 222 patient monitors because they may fail to provide audible alarms in End Case mode, a defect missed in a previous recall.

    Product
    Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1606-2014·2014-10-01

    Baxter Recalls Potassium Chloride Bags Due to Mispackaging Error

    Baxter Healthcare is recalling 148,632 bags of Potassium Chloride Injection because shipping cartons were incorrectly labeled and contained Gentamicin Sulfate Injection instead.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2491-2014·2014-10-01

    4C HomeStyle Parmesan Grated Cheese Recalled for Salmonella Contamination

    4C Foods Corp. is recalling 4C HomeStyle Parmesan Grated Cheese due to Salmonella contamination. The product was distributed in eight states.

    Product
    4C GRATED CHEESE HOMESTYLE 100% NATURAL PARMESAN, NET WT. 6 OZ. (170g) glass jars, UPC Number:0-41387-32790-8. Manufactured by 4C FOOD CORP., BROOKLYN, NY 11208. Product of USA.
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2695-2014·2014-10-01

    PDG Fuze Manual Tilt Wheelchairs Recalled for Axle Plate Detachment Risk

    PDG Product Design Group is recalling Fuze T50, T20, and T50 Jr manual tilt wheelchairs because a hex bolt head might shear, causing the axle plate to detach and the wheels to collapse.

    Product
    Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Food)·F-2507-2014·2014-10-01

    Supreme Choice Pasteurized Crab Meat Recalled for Botulism Risk

    Supreme Distributors, Inc. is recalling Supreme Choice brand Premium Pasteurized Crab Meat due to a potential hazard of Clostridium botulinum toxin formation from temperature abuse.

    Product
    Supreme Choice brand Special, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14V606000·2014-09-29

    Navistar Recalls 2015 International TranStar Trucks for Clutch Nut Issue

    Navistar is recalling 78 model year 2015 International TranStar vehicles because a clutch rod nut may be missing or loose, which could cause the vehicle to lunge unexpectedly and increase crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL TRANSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E066000·2014-09-29

    Emerson Recalls Fisher Pressure Relief Valves Used in Cargo Tank Trailers

    Emerson is recalling specific Fisher pressure relief valves used in cargo tank trailers because they may break and eject, posing risks of injury, fire, or road hazards.

    Product
    FUEL SYSTEM, OTHER:STORAGE:TANK ASSEMBLY:PRESSURE RELIEF DEVICES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·062-2014·2014-09-27

    Delicious Beef Jerky Recalled for Missing Inspection Mark

    Delicious Beef Jerky, LLC is recalling 8 pounds of Lemon Pepper Seasoned Beef Jerky because the products were produced and shipped without the required USDA inspection.

    Product
    Delicious Beef Jerky — New Mexico Firm Recalls Beef Jerky Products Incorrectly Produced and Shipped with the Mark of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14V597000·2014-09-26

    Ford Recalls 2013-2014 Models for Restraint Control Module Defect

    Ford is recalling 2013-2014 C-Max, Fusion, Escape, and Lincoln MKZ vehicles because a defect in the Restraint Control Module may prevent airbags and seat belt pretensioners from functioning in a crash.

    Product
    FORD — FORD, LINCOLN ESCAPE, FUSION, MKZ, C-MAX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V596000·2014-09-26

    Polaris Recalls 2015 Victory Motorcycles Due to Transmission Defect

    Polaris is recalling 2015 Victory motorcycles because a transmission spring may be installed incorrectly, potentially causing loss of control.

    Product
    VICTORY — VICTORY VISION TOUR ABS, MAGNUM, CROSS COUNTRY TOUR, CROSS COUNTRY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V598000·2014-09-26

    Mercedes-Benz Recalls 2015 C300 and C400 for Steering Defect

    Mercedes-Benz is recalling 2015 C300 and C400 vehicles because a steering component may disengage, potentially causing loss of control.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ C400, C300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·061-2014·2014-09-25

    Caviness Beef Packers Recalls Beef Trimmings Due To E. Coli O157:H7

    Caviness Beef Packers is recalling approximately 23,100 pounds of beef trimmings produced in August 2014 due to possible E. coli O157:H7 contamination.

    Product
    Caviness Beef Packers, Ltd. — Texas Firm Recalls Beef Products Due To Possible E. Coli O157:H7
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2484-2014·2014-09-24

    Raw Goat Milk Cheddar Cheese Recalled for E. coli O111:H8 Contamination

    Mt. Sterling Coop Creamery is recalling specific lots of raw goat milk cheddar cheese due to potential contamination with Shiga toxin-producing E. coli O111:H8.

    Product
    Raw Milk Mild Cheddar Cheese, in 8 oz, (UPC 79004-10002) and 5 lb. (no UPC) size packages.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1587-2014·2014-09-24

    Unique Pharmaceutical Recalls Repinephrine IV Bags Due to Sterility Concerns

    Unique Pharmaceutical is recalling 430 bags of Repinephrine 4 mg in 250 mL Sodium Chloride 0.9% because a mold-like substance was found on an unopened bag during production.

    Product
    NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1590-2014·2014-09-24

    Oxcarbazepine Tablets Recalled Due to Labeling Error

    American Health Packaging is recalling Oxcarbazepine Tablets due to a label mix-up with Ibuprofen tablets.

    Product
    Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 62584-143-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1593-2014·2014-09-24

    Baxter Recalls Potassium Chloride Injection Due to Particulate Matter

    Baxter Healthcare is recalling 171,672 bags of Potassium Chloride Injection due to the presence of particulate matter, including fibers and plastics.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1602-2014·2014-09-24

    XZONE GOLD recalled for undeclared erectile dysfunction drug ingredients

    Nova Products, Inc. is voluntarily recalling XZONE GOLD capsules because FDA testing found undeclared sildenafil and tadalafil.

    Product
    XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orlando, FL 32789
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2642-2014·2014-09-24

    EMG Technology Recalls Vac-Assist Suction Units Due to Occluded Ports

    EMG Technology is recalling 1,452 Vac-Assist Suction Units because the canister lids may have occluded ports, potentially preventing proper fluid removal.

    Product
    Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.
    Category
    Medical Device
    Distribution
    1 state