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.

28451–28475 of 32252

  • SevereNHTSA·13V175000·2013-05-07

    Chrysler Recalls Jeep Grand Cherokee and Commander for Electrical Defect

    Chrysler is recalling 2005-2010 Jeep Grand Cherokee and 2006-2010 Jeep Commander vehicles because an electrical failure may cause the transfer case to shift into neutral, increasing crash risk.

    Product
    JEEP — JEEP GRAND CHEROKEE, COMMANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V174000·2013-05-06

    Dutchmen Recalls 2013 Breckenridge RVs Due to Awning Motor Defect

    Dutchmen is recalling 2013 Breckenridge recreational vehicles because an awning motor defect may cause the awning to unfurl unexpectedly, increasing the risk of injury or a crash.

    Product
    BRECKENRIDGE — BRECKENRIDGE BRECKENRIDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·13182·2013-05-02

    LEM 5-Tray Food Dehydrators Recalled Due to Fire Hazard

    LEM Products Distribution is recalling 5-Tray Food Dehydrators because a fan failure can cause the unit to overheat and start a fire. Consumers should stop using the product and contact the company for repair.

    Product
    5-Tray Dehydrator with Digital Timer
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V172000·2013-05-02

    BMW Recalls 2002-2003 Models Due to Passenger Air Bag Defect

    BMW is recalling 2002-2003 models because the passenger air bag inflator may rupture, sending metal fragments into the cabin during a crash.

    Product
    BMW — BMW 325XI, 325IT, M3, 325XIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-283-2013·2013-05-01

    BiMix Standard Injectable Recalled for Lack of Sterility Assurance

    Axium Healthcare Pharmacy is recalling BiMix Standard Injectable due to lack of sterility assurance and quality control concerns.

    Product
    BiMix Standard Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-285-2013·2013-05-01

    FDA Recalls Quadmix Custom Injectable Due to Sterility Assurance Concerns

    Axium Healthcare Pharmacy is recalling Quadmix Custom Injectable vials due to lack of sterility assurance and quality control concerns.

    Product
    Quadmix Custom Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-1347-2013·2013-05-01

    Wild Blue Yonder Recalls Gluten-Free Granola for Undeclared Almonds

    Wild Blue Yonder Foods is recalling Chappaqua Crunch GF Simply Granola with Flax & Fruit due to undeclared almonds. The product was distributed in nine states.

    Product
    Chappaqua Crunch GF(Gluten Free) Simply Granola with Flax & Fruit , 12 ounce pouch UPC: 786516-76002 6
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Drugs)·D-281-2013·2013-05-01

    Axium Healthcare Recalls Mono-mix Injectable Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Mono-mix (Prostaglandin) Injectable due to lack of assurance of sterility and quality control concerns.

    Product
    Mono-mix (Prostaglandin) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1168-2013·2013-05-01

    GE Healthcare Recalls Ventri Discovery NM 530c Nuclear Imaging Systems

    GE Healthcare is recalling 556 Ventri Discovery NM 530c nuclear imaging systems because a moving table mechanism can pinch patient fingers during an exam.

    Product
    Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures.
    Category
    Medical Device
    Distribution
    40 states
  • SevereFDA (Drugs)·D-275-2013·2013-05-01

    Axium Healthcare Recalls Cyanocobalamin Injectables Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Cyanocobalamin (CMP) Injectable vials due to a lack of assurance of sterility and quality control concerns.

    Product
    Cyanocobalamin (CMP) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-276-2013·2013-05-01

    FDA Recalls Methylcobalamin and Folic Acid Injectables Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Methylcobalamin and Folic Acid Injectables because the products may lack sterility assurance.

    Product
    Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1157-2013·2013-05-01

    Spinal Solutions Recalls APLIF Implants Due to Inadequate Testing

    Spinal Solutions is recalling 220 APLIF implants because they lack adequate testing to prove safety. The defect could cause implant breakage or movement.

    Product
    APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - 10degree 184010-10 Anterior Psoas Lumbar 18 x 40 x 10mm - 10degree 184012-10 Anterior Psoas Lumbar 18 x 40 x 12mm - 10degree 184014-10 Anterior Psoas Lumbar 18 x 40 x 14mm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-286-2013·2013-05-01

    Axium Healthcare Recalls 17 Alpha Hydroxyprogesterone Caproate Injectable Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling 17 Alpha Hydroxyprogesterone Caproate Injectable vials due to lack of sterility assurance and quality control concerns.

    Product
    17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-287-2013·2013-05-01

    QuadMix Injectable Recalled for Lack of Sterility Assurance

    Axium Healthcare Pharmacy is recalling QuadMix Injectable due to lack of sterility assurance and quality control concerns.

    Product
    QuadMix Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-273-2013·2013-05-01

    Betamethasone Injectable Recalled Due to Lack of Sterility Assurance

    Axium Healthcare Pharmacy is recalling Betamethasone Injectable due to lack of sterility assurance and quality control concerns.

    Product
    Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-295-2013·2013-05-01

    Axium Healthcare Recalls Cyclosporin Injectable Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling all lots of Cyclosporin in Corn Oil Injectable due to lack of assurance of sterility and quality control concerns.

    Product
    Cyclosporin in Corn Oil Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-284-2013·2013-05-01

    BiMix Plus Injectable Recalled Due to Lack of Sterility Assurance

    Axium Healthcare Pharmacy is recalling BiMix Plus Injectable due to lack of sterility assurance and quality control concerns.

    Product
    BiMix Plus Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-280-2013·2013-05-01

    Axium Healthcare Recalls Comprehensive Injection #4 Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Comprehensive Injection #4 because the compounding process lacked assurance of sterility. The product was distributed in Colorado, Georgia, Michigan, and Puerto Rico.

    Product
    Comprehensive injection #4 - SS varied injectable Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1156-2013·2013-05-01

    Orthopedic Alliance Recalls Blue & Gold Spine System Implants

    Orthopedic Alliance LLC is recalling Blue & Gold Spine System implants and instruments because the system lacks adequate testing and documentation to demonstrate it meets performance or safety standards.

    Product
    Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BGC3010 Screw Cap BGR0040 Straight Rod 5.5 x 40mm BGR0050 Straight Rod 5.5 x 50mm BGR0060 Straight Rod 5.5 x 60mm BGR0070 Straight Rod 5.5 x 70mm BGR0080 Straight Rod 5.5 x 80mm BGR0090 Straight Rod…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-290-2013·2013-05-01

    FDA Recalls Triamcinolone Diacetate Injectable Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling 172 vials of Triamcinolone Diacetate Injectable due to lack of sterility assurance and quality control concerns.

    Product
    Triamcinolone Diacetate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-293-2013·2013-05-01

    Axium Healthcare Recalls Sodium Tetradecyl Sulfate Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Sodium Tetradecyl Sulfate for Injectable due to lack of assurance of sterility and quality control concerns.

    Product
    Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-292-2013·2013-05-01

    HCG Lyophilized Powder Recalled for Lack of Sterility Assurance

    Axium Healthcare Pharmacy is recalling HCG Lyophilized Powder 10,000 unit for Injectable due to lack of sterility assurance. The product was distributed in Colorado, Georgia, Michigan, and Puerto Rico.

    Product
    HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-277-2013·2013-05-01

    Progesterone Injectable Recalled Due to Lack of Sterility Assurance

    Axium Healthcare Pharmacy is recalling all lots of Progesterone in Olive Oil Injectable due to lack of sterility assurance and quality control concerns.

    Product
    Progesterone in Olive Oil Injectable Balanced Solutions, Compounding Pharmacy a division ofAxium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereNHTSA·13V171000·2013-05-01

    Volvo Bus 9700 Recall: Software Defect May Fix Throttle Speed

    Volvo Bus is recalling 2009-2013 9700 coaches because a software defect may fix the throttle at 1750 RPMs, preventing drivers from controlling speed.

    Product
    VOLVO BUS — VOLVO BUS 9700
    Category
    Vehicle
    Distribution
    Distributed nationwide