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.

18051–18075 of 29217

  • SevereNHTSA·16V557000·2016-07-26

    Load Trail Triple Axle Tilt Deck Trailers Recalled for Weld Defects

    Load Trail is recalling 2014-2016 Triple Axle Tilt Deck trailers because weld joints may crack, potentially causing equipment to disengage and increasing crash risk.

    Product
    LOAD TRAIL — LOAD TRAIL TRIPLE AXLE TILT DECK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E065000·2016-07-25

    ZF Transmission Sensor Clusters Recalled for Unexpected Neutral Shifts

    ZF North America is recalling certain 9-speed automatic transmission sensor clusters due to insufficient wire harness crimps that may cause the vehicle to unexpectedly shift to neutral.

    Product
    POWER TRAIN:AUTOMATIC TRANSMISSION:CONTROL MODULE (TCM/PCM/TECM) recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V550000·2016-07-22

    2017 Coachmen Freedom Express Recalled for Tire Rubbing Hazard

    Forest River is recalling 2017 Coachmen Freedom Express recreational vehicles because insufficient space between the driveshaft and tires may cause tire failure and loss of control.

    Product
    COACHMEN — COACHMEN FREEDOM EXPRESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V548000·2016-07-22

    Mitsubishi Outlander Sport Recall for CVT Hose Clamp Defect

    Mitsubishi is recalling 2015 Outlander Sport vehicles because a CVT hose clamp may not be secured, risking fluid leaks, inoperability, or fire.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1646-2016·2016-07-20

    Dr. Praeger's California Veggie Burgers Recalled for Listeria Risk

    Dr. Praeger's Sensible Foods is voluntarily recalling California Veggie Burgers because they may be contaminated with Listeria monocytogenes.

    Product
    Dr. Praeger's California Veggie Burgers, 26 x 10 oz./box, Best if used by: May-18-2018, UPC 0 80868 00010, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1335-2016·2016-07-20

    Pharmakon Recalls Cefazolin Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Cefazolin 1GM syringes because the company cannot ensure the product is sterile.

    Product
    Cefazolin 1GM in Sterile Water, 10 ml BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0960-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1302-2016·2016-07-20

    Pharmakon Recalls Magnesium Sulfate Injection Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 10 bags of Magnesium Sulfate 1GM in 0.9% Sodium Chloride due to a lack of assurance of sterility.

    Product
    Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride, 50 mL bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0803-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1172-2016·2016-07-20

    Medaus Recalls B-Complex 50 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling B-Complex 50 in NaCl 0.9% vials because the company cannot assure the sterility of the product.

    Product
    B-COMPLEX 50 IN NACL 0.9% (PF) B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 2ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1343-2016·2016-07-20

    Pharmakon Recalls Bupivacaine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 70 units of Bupivacaine HCI 0.25% bags because the company cannot assure the products are sterile.

    Product
    Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0994-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1652-2016·2016-07-20

    Dr. Praeger's Recalls Black Bean Veggie Burgers Due to Listeria Risk

    Dr. Praeger's Sensible Foods is voluntarily recalling specific lots of Black Bean Veggie Burgers because they may be contaminated with Listeria monocytogenes.

    Product
    Dr. Praeger's Black Bean Veggie Burger, 12 x 10 oz. (283 g)/box, Best if used by: May-12-2018, UPC 0 80868 06019 4, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1199-2016·2016-07-20

    Medaus Recalls L-Phenylalanine Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of L-Phenylalanine 15mg/mL vials because the FDA cannot assure the product is sterile.

    Product
    L-PHENYLALANINE 15MG/ML (PF), 50ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1631-2016·2016-07-20

    Dr. Praeger's Organic Harvest Veggie Burgers Recalled for Listeria Risk

    Dr. Praeger's is voluntarily recalling Organic Harvest Veggie Burgers because they may be contaminated with Listeria monocytogenes.

    Product
    Dr. Praeger's Purely Sensible Foods Organic Harvest Veggie Burgers, 10 x 48 oz (1.36kg), Best if used by: May 16, 2017, UPC 0 8086830110 5, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2142-2016·2016-07-20

    Hospira LifeCare Pump Model 4200 PCA Infuser Recalled for Occlusion Detection Failure

    Hospira is recalling 6,268 LifeCare Pump Model 4200 PCA Infusers because they may fail to detect distal occlusions, a defect that caused one serious injury.

    Product
    The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1213-2016·2016-07-20

    Medaus Recalls Manganese Sulfate Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Manganese Sulfate vials because the company cannot guarantee the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    MANGANESE SO4 0.1MG/ML (PF), In a) 2MLVials and b) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1328-2016·2016-07-20

    Pharmakon Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 340 units of Morphine Sulfate syringes due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD locations.

    Product
    Morphine Sulfate 5mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0935-67
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1315-2016·2016-07-20

    Pharmakon Recalls Morphine Sulfate Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 215 bags of Morphine Sulfate in Dextrose due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Morphine Sulfate 1 mg/mL in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0875-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1169-2016·2016-07-20

    Medaus Recalls B-Complex Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling B-Complex (Lieberman) in NaCl 0.9% (PF) 2 mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.

    Product
    B-COMPLEX (LIEBERMAN) IN NACL 0.9% (PF), B1-12.5MG, B2-5-PO4-10MG, B3-12.5MG, B5-12.5MG, B6-12.5MG/ML, 2ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1257-2016·2016-07-20

    Pharmakon Recalls Bupivacaine Injection Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 130 bags of Bupivacaine 1mg/mL injection due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.

    Product
    Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0019-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1174-2016·2016-07-20

    Medaus Recalls B-Complex Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of B-Complex with Cyanocobalamin vials because the company cannot ensure the product is sterile.

    Product
    B-COMPLEX W/CYANO B12 W/PRES., (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, CYANO B12 1MG/ML, In a) 2ML Vials, b) 5MLVials, c) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1167-2016·2016-07-20

    Medaus Recalls B-Complex #3 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling B-Complex #3 vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    B-COMPLEX #3 (PF), B1-100MG, B2-2-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 2ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1243-2016·2016-07-20

    Medaus Recalls Testosterone Cypionate Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Testosterone Cypionate vials because the company cannot guarantee the product is sterile.

    Product
    TESTOSTERONE CYP 20 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials and b) 3ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1268-2016·2016-07-20

    Pharmakon Recalls Adenosine Injection Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 12 units of Adenosine 1mg/ml injection due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.

    Product
    Adenosine 1mg/ml (PF) in 0.9% Sodium Chloride (Total 90 mg/90 ml in 100 mL PAB Container); Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0146-47
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1341-2016·2016-07-20

    Pharmakon Recalls Midazolam HCl Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 10 bags of Midazolam HCl 1mg/mL due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Midazolam HCl 1mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0989-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1225-2016·2016-07-20

    Medaus Recalls M.I.C 25/50/50 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling M.I.C 25/50/50 vials because the product lacks assurance of sterility. The recall affects 2,000 mL in vials distributed in the U.S., Japan, and New Zealand.

    Product
    M.I.C 25/50/50 W/METHYL B12 1MG/PYRIDOXAL 50MG/ML (PF), 1ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide