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.

26101–26125 of 32215

  • SevereFDA (Food)·F-1457-2014·2014-02-05

    Health Wright Recalls Zinc Plus Supplements Contaminated with Chloramphenicol

    Health Wright Products Inc is recalling Zinc Plus dietary supplements because they were made from an ingredient contaminated with Chloramphenicol.

    Product
    Zinc Plus, Mineral/Enzyme supplement, 90 vegetable capsules per bottle. They are sold under brand Enzyme Research Products.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0838-2014·2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 2 units of the Aquarius Hot/Cold Therapy Combo Unit due to temperature monitoring failures and electric shock reports.

    Product
    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1459-2014·2014-02-05

    Health Wright Enzyme Formula Recalled for Chloramphenicol Contamination

    Health Wright Products Inc. is recalling Enzyme Formula dietary supplements because they were made from ingredients contaminated with Chloramphenicol.

    Product
    Enzyme Formula, dietary supplement, 100 capsules or 250 capsules per bottles, sold unlabeled to Rich Distributing.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1039-2014·2014-02-05

    Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns

    The Mentholatum Company is recalling several Rohto eye drop products due to concerns about the quality assurance of sterility controls.

    Product
    ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01096 1, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1454-2014·2014-02-05

    Health Wright B-Complex Supplement Recalled for Chloramphenicol Contamination

    Health Wright Products Inc. is recalling B-Complex with Enzymes supplements contaminated with Chloramphenicol. The affected product was distributed to five US states and Mexico.

    Product
    B-Complex with Enzymes, Vitamin/Enzyme Supplement. Packaged 60 vegetable capsules per bottle. They are sold under brand Enzyme Research Products.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0834-2014·2014-02-05

    DeRoyal Aquarius Temperature Therapy Units Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 738 Aquarius Temperature Therapy units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

    Product
    Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0859-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff is recalling 895 Certas Programmable Valves used for hydrocephalus because they may not operate properly.

    Product
    Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0836-2014·2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 409 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

    Product
    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1455-2014·2014-02-05

    Health Wright B-Complex Plus Recalled Due to Chloramphenicol Contamination

    Health Wright Products Inc is recalling B-Complex Plus dietary supplements because they were made from an ingredient contaminated with Chloramphenicol.

    Product
    B-Complex Plus. They are sold under brand Enzyme Research Products
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0839-2014·2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 25 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

    Product
    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1051-2014·2014-02-05

    NuVision Pharmacy Recalls HCG Vials Due to Sterility Assurance Concerns

    NuVision Pharmacy is recalling 285 vials of HCG (Lyophilized) nationwide due to a lack of sterility assurance identified during an FDA inspection.

    Product
    HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1041-2014·2014-02-05

    Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns

    The Mentholatum Company is recalling several Rohto eye drop products due to concerns about the quality assurance of sterility controls.

    Product
    ROHTO Redness Relief, Cool, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01074 9, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1037-2014·2014-02-05

    Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns

    The Mentholatum Company is recalling Rohto eye drops because of concerns about sterility controls. The recall covers nationwide distribution and Puerto Rico.

    Product
    ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 10909 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1040-2014·2014-02-05

    Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns

    The Mentholatum Company is recalling several Rohto eye drop products due to concerns about the quality assurance of sterility controls.

    Product
    ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent, Lubricant, Redness Reliever Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01099 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0837-2014·2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature and Shock Risks

    DeRoyal Industries is recalling 48 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature and have caused electric shocks.

    Product
    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1038-2014·2014-02-05

    Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns

    The Mentholatum Company is recalling Rohto eye drops because of concerns about the quality assurance of sterility controls.

    Product
    ROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01086 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0862-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff is recalling 369 Certas Programmable Valves used for hydrocephalus because they may not operate properly.

    Product
    Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code: 82-8805 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0860-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff, Inc. is recalling 431 Codman Certas Programmable Valves because they may not operate properly. These implantable devices are used to manage hydrocephalus.

    Product
    Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1461-2014·2014-02-05

    YOR Digest Ultra Recalled Due to Chloramphenicol Contamination

    Health Wright Products Inc. is recalling YOR Digest Ultra dietary supplements because they were made with ingredients contaminated with Chloramphenicol.

    Product
    Digest Ultra, dietary supplement, packaged 56 capsules per bottle or distributed in bulk, sold under brand YOR. Product distributed OUTSIDE the US has Spanish label.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1458-2014·2014-02-05

    Digestaze dietary supplement recalled due to Chloramphenicol contamination

    Health Wright Products Inc is recalling Digestaze dietary supplements because they were made from an ingredient contaminated with Chloramphenicol.

    Product
    Digestaze, dietary supplement, 90 vegetable capsules per bottle. They are sold under brand DESBIO
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1035-2014·2014-02-05

    Hospira Recalls Aminosyn 3.5% Bags Due to Sterility Concerns

    Hospira Inc. is recalling 15,258 bags of Aminosyn 3.5% M Sulfite-Free due to a lack of assurance of sterility and potential leakage from the administrative port.

    Product
    Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc, Lake Forest, IL, 60045. NDC: 0409-4196-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1036-2014·2014-02-05

    Hospira Recalls Heparin Sodium Bags Due to Sterility Concerns

    Hospira is recalling 27,780 bags of Heparin Sodium 2000 USP Units per 1000 mL due to a lack of assurance of sterility and potential leakage from the administrative port.

    Product
    HEPARIN SODIUM — HEPARIN SODIUM (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1460-2014·2014-02-05

    Health Wright Recalls XymoZyme Dietary Supplements Due to Chloramphenicol Contamination

    Health Wright Products Inc is recalling XymoZyme dietary supplements because the ingredients were contaminated with Chloramphenicol. The affected products were distributed to California, Florida, Oregon, Utah, and Mexico.

    Product
    XymoZyme, dietary supplement, packaged 60 capsules per bottte, 120 capsules per bottle, sold under brand ZYMOGEN.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0835-2014·2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 121 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

    Product
    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide