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.

12151–12175 of 29164

  • SevereFDA (Devices)·Z-1117-2019·2019-05-01

    Edwards Miller Balloon Atrioseptostomy Catheter Recalled for Deflation Issues

    Edwards Lifesciences is recalling Miller Balloon Atrioseptostomy Catheters due to difficulty deflating the balloon and reports of fragmentation or detachment.

    Product
    Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F Product Usage: The Miller balloon atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1209-2019·2019-05-01

    Dexmedetomidine Bags Recalled for Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 5,678 bags of Dexmedetomidine 400 mcg in NS 100 mL due to a lack of sterility assurance. The affected products were distributed in North Carolina.

    Product
    Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1232-2019·2019-05-01

    Phenylephrine IV Bags Recalled for Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 215 bags of Phenylephrine 40 mg in 0.9% Sodium Chloride due to a lack of sterility assurance. The product was distributed in North Carolina.

    Product
    Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1239-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Vancomycin Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 532 bags of Vancomycin 2000 mg in 0.9% Sodium Chloride due to a lack of sterility assurance.

    Product
    Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1216-2019·2019-05-01

    Magnesium Sulfate IV Bags Recalled Due to Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 196 bags of Magnesium Sulfate 6 GM in NS 50 mL due to a lack of sterility assurance. The product was distributed in North Carolina.

    Product
    Magnesium Sulfate 6 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1218-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Norepinephrine Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 2,567 bags of Norepinephrine 16 mg in NS 250 mL due to a lack of sterility assurance. The affected products were distributed in North Carolina.

    Product
    Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1233-2019·2019-05-01

    Sodium Bicarbonate IV Bags Recalled for Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 100 bags of Sodium Bicarbonate 150 mEq in D5W 1000 mL due to lack of sterility assurance.

    Product
    Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1240-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls DelNido Cardioplegia Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 110 bags of DelNido Cardioplegia in North Carolina due to a lack of sterility assurance.

    Product
    DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Mannitol 20%-16.3 mL, Potassium Chloride 2 meq/mL-13 mL, Sodium Bicarbonate 8.4%-Lidocaine 1%-1:1 Dilution-26 mL, Magnesium Sulfate 500 mg/mL-4 mL, Cardiac Perfusion Only - Not for IV Use, Made by…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1211-2019·2019-05-01

    Diltiazem 250 mg IV Bags Recalled for Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 1,475 bags of Diltiazem 250 mg in NS 250 mL due to a lack of sterility assurance. The product was distributed in North Carolina.

    Product
    Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·19V337000·2019-04-30

    Smeal Recalls 2017-2019 Aerial Fire Apparatus Due to Missing Welds

    Smeal is recalling 2017-2019 Aerial Fire Apparatus vehicles because missing joint welds in the base rail may cause the aerial device to collapse.

    Product
    SMEAL — SMEAL AERIAL FIRE APPARATUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V338000·2019-04-30

    Spartan Gladiator Aerial Vehicles Recalled for Frame Cracks

    Spartan Motors is recalling 2004-2016 Gladiator aerial vehicles because cracks in the tiller frame may cause the device to fall, risking injury.

    Product
    SPARTAN — SPARTAN GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V334000·2019-04-29

    Airstream Recalls 2018-2020 Travel Trailers Due to Spare Tire Carrier Defect

    Airstream is recalling 2018-2020 travel trailers because the spare tire carrier may contact the ground, causing the tire to detach and create a road hazard.

    Product
    AIRSTREAM — AIRSTREAM TOMMY BAHAMA, FLYING CLOUD, INTERNATIONAL, NEST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V330000·2019-04-26

    Mitsubishi Recalls 2017-2018 Mirage G4 for Air Bag Software Defect

    Mitsubishi is recalling 26,016 2017-2018 Mirage G4 vehicles because a software error may disable air bags. Dealers will reprogram the system free of charge.

    Product
    MITSUBISHI — MITSUBISHI MIRAGE G4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V324000·2019-04-25

    Ram 1500 Recall: Rear Driveshaft Weld Defect May Cause Fracture

    FCA US is recalling 2018-2019 Ram 1500 trucks because an incomplete weld on the rear driveshaft may crack or fracture, creating a road hazard or loss of drive power.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V328000·2019-04-25

    GM Recalls 2017-2019 Chevrolet and GMC Trucks for Fire Risk

    General Motors is recalling specific 2017-2019 Chevrolet Silverado and GMC Sierra trucks because a short circuit in the engine block heater could cause a fire.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 4500, SILVERADO 2500, SILVERADO 3500, SIERRA 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V327000·2019-04-25

    Volvo Recalls 2019 S60 Vehicles for Rear Suspension Lock Nut Issue

    Volvo is recalling 2019 S60 vehicles because rear suspension lock nuts may not be properly tightened, which could cause sudden handling changes and increase crash risk.

    Product
    VOLVO — VOLVO S60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1184-2019·2019-04-24

    Serum Tears 50% Ophthalmic Drops Recalled for Sterility Assurance Issues

    Anderson Compounding Pharmacy is recalling Serum Tears 50% Ophthalmic Drops due to a lack of sterility assurance. All lots are affected nationwide.

    Product
    Serum Tears 50% Ophthalmic Drops, 1 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1204-2019·2019-04-24

    FDA Recalls Prostaglandin Tri-Mix Injection Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling Prostaglandin Tri-Mix 30:30:1 Injection vials nationwide due to a lack of sterility assurance.

    Product
    Prostaglandin Tri-Mix 30:30:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1183-2019·2019-04-24

    Methylcobalamin Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Methylcobalamin 3000 mcg/mL Injection Solution due to a lack of sterility assurance.

    Product
    Methylcobalamin 3000 mcg/mL Injection Solution, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1187-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Neomycin and Polymixin B Bladder Irrigation Solution

    Anderson Compounding Pharmacy is recalling Neomycin 40 mg/Polymixin B 200,000 Bladder Irrigation Solution due to a lack of sterility assurance.

    Product
    Neomycin 40 mg/Polymixin B 200,000 Bladder Irrigation Solution, 1000 mL bottle, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1174-2019·2019-04-24

    FDA Recalls Prostaglandin Tri-Mix Vials Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling Prostaglandin Tri-Mix 50:30:1 vials nationwide due to a lack of sterility assurance.

    Product
    Prostaglandin Tri-Mix 50:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide