The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

30201–30225 of 50499

  • HighFDA (Drugs)·D-0141-2018·2018-01-03

    SSM St. Clare Recalls Neostigmine Methylsulfate Syringes Due to Sterility Concerns

    SSM St. Clare Health Center is recalling compounded Neostigmine Methylsulfate syringes because microbial growth was detected during a routine manufacturing simulation. No distributed product has been confirmed to contain microorganisms.

    Product
    Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0329-01
    Category
    Drug
    Distribution
    1 state
  • HighCPSC·18076·2018-01-02

    Comfort Research Recalls Ultra Lounge Bean Bag Chair Covers

    Comfort Research is recalling about 1,200 Ultra Lounge bean bag chair covers due to risks of entrapment and suffocation to children.

    Product
    Ultra Lounge bean bag chair covers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V001000·2018-01-02

    Erwin Hymer Recalls Motorhomes With Defective Fire Extinguishers

    Erwin Hymer is recalling 2012-2018 motorhomes because the installed fire extinguishers may clog and fail to discharge properly.

    Product
    ROADTREK — ROADTREK, CARADO, SUNLIGHT ZION, RS ADVENTUROUS, BANFF, AXION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V847000·2017-12-29

    ShowHauler Recalls 2003-2018 Motorhomes Due to Fire Extinguisher Defect

    ShowHauler is recalling 2003-2018 Garage Coach, Toter Coach, and Motorhome vehicles because their fire extinguishers may clog or detach, posing injury risks during a fire.

    Product
    SHOWHAULER — SHOWHAULER GARAGE COACH, TOTER COACH, MOTORHOME
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18073·2017-12-28

    Western Gas Recalls Propane Due to Fire and Burn Hazards

    Western Gas is recalling under-odorized propane gas due to fire, explosion, and burn hazards. Consumers should contact their supplier for a free inspection.

    Product
    Propane (LP) Gas
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0513-2018·2017-12-27

    Kroger Dark Chocolate Covered Raisins Recalled for Undeclared Milk Allergen

    The Kroger Co is recalling All Natural Dark Chocolate Covered Raisins because they may contain an undeclared milk allergen. The product was distributed in Michigan.

    Product
    All Natural Dark Chocolate Covered Raisins INGREDIENTS: Dark Chocolate (Sugar Chocolate Liquor, Cocoa Butter, Chocolate Liquor Processed W/Alkali, Soy Lecithin (An Emulsifier), Vanilla, Salt,), raisins And Confectioners Glaze. DIST BY THE KROGER CO CINCINNATI, OHIO 45201
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0264-2018·2017-12-27

    BioMerieux Recalls ETEST Oxacillin Strips Due to Quality Control Failures

    BioMerieux SA is recalling ETEST Oxacillin strips due to quality control failures that may cause false resistant results.

    Product
    ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0265-2018·2017-12-27

    BioMerieux Recalls ETEST OXACILLIN Strips Due to Quality Control Failures

    BioMerieux SA is recalling ETEST OXACILLIN OX 256 WW F100 in vitro diagnostic strips due to quality control failures that may cause false resistant results.

    Product
    ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0512-2018·2017-12-27

    Kroger Dark Chocolate Covered Pretzel Balls Recalled for Undeclared Milk

    The Kroger Co is recalling All Natural Dark Chocolate Covered Pretzel Balls because they may contain an undeclared milk allergen. The product was distributed in Michigan.

    Product
    All Natural Dark Chocolate Covered Pretzel Balls INGREDIENTS: DARK CHOCOLATE (SUGAR, CHOCOLATE LIQUOR, COCOA BUTTER, CHOCOLATE LIQUOR PROCESSED WITH ALKALI, SOY LECITHIN (EMULSIFIER), SALT, VANILLA), PRETZEL BALLS (ENRICHED WHEAT FLOUR (WHEAT FLOUR, NIACIN, REDUCED IRON…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0503-2018·2017-12-27

    Sensations Cinnamon Roll Dough Recalled for Undeclared Pecans

    AMS LLC dba Gagne Foods is recalling 37 cases of Sensations cinnamon roll UNCOOKED DOUGH 450g in Canada due to undeclared pecans.

    Product
    Sensations cinnamon roll UNCOOKED DOUGH 450g, UPC: 236821197
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0279-2018·2017-12-27

    Zimmer Dental GemLock Hex Driver Recalled for Manufacturing Defect

    Zimmer Dental Inc. is recalling 356 GemLock RHD2.5 Hex Drivers because a manufacturing defect may prevent the tool from properly engaging dental fixtures.

    Product
    Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0510-2018·2017-12-27

    Kroger Recalls Dark Chocolate Covered Cranberries Due to Undeclared Milk Allergen

    The Kroger Co is recalling 4,127 pounds of All Natural Dark Chocolate Covered Cranberries because the product may contain an undeclared milk allergen.

    Product
    All Natural Dark Chocolate Covered Cranberries INGREDIENTS: DARK CHOC (SUGAR, CHOC LIQUOR, COCOA BUTTER, SALT, VANILLA) CRANBERRIES, CONFECTIONERS GLAZE. DIST BY THE KROGER CO CINCINNATI, OHIO 45201
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0262-2018·2017-12-27

    Rezum System Recall Due to Potential Needle Bond Failure During Prostate Treatment

    NxThera is recalling 113 Rezum System units because the needle bond may fail during deployment, posing a risk of injury to patients.

    Product
    Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. Intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for…
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Food)·F-0508-2018·2017-12-27

    Kroger Dark Chocolate Covered Almonds Recalled for Undeclared Milk Allergen

    The Kroger Co is recalling All Natural Dark Chocolate Covered Almonds because the product may contain an undeclared milk allergen.

    Product
    All Natural Dark Chocolate Covered Almonds INGREDIENTS: Natural Dark Chocolate (Sugar Chocolate Liquor, Cocoa Butter, Chocolate Liquor Processed W/Alkali, Soy Lecithin (An Emulsifier), Vanilla, Salt,), Almonds And Confectioners Glaze. DIST BY THE KROGER CO CINCINNATI, OHIO 45201
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0257-2018·2017-12-27

    Terumo Overpressure Safety Valve Recall Due to No Flow Reports

    Terumo CVS is recalling custom surgical kits containing Overpressure Safety Valves due to reports of no flow through the valve.

    Product
    Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130 74369 71156 71551-02 71413 71692…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0274-2018·2017-12-27

    Qiagen QIAamp DSP Virus Kit Recalled for Decreased Performance

    Qiagen is recalling specific lots of the QIAamp DSP Virus Kit because they may result in decreased performance in analytic workflows.

    Product
    QIAamp DSP Virus Kit Cat. No. 60704
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0509-2018·2017-12-27

    Kroger Dark Chocolate Covered Coffee Beans Recalled for Undeclared Milk Allergen

    The Kroger Co is recalling All Natural Dark Chocolate Covered Coffee Beans because they may contain an undeclared milk allergen. The product was distributed in Michigan.

    Product
    All Natural Dark Chocolate Covered Coffee Beans INGREDIENTS: DARK CHOCOLATE (SUGAR, CHOCOLATE LIQUOR, COCOA BUTTER, CHOCOLATE LIQUOR PROCESSED WITH ALKALI, SOY LECITHIN (AN EMULSIFIER), VANILLA, SALT, AND ARTIFICIAL FLAVORING ADDED), DRY ROASTED COFFEE BEANS AND CONFECTIONERS…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0266-2018·2017-12-27

    Medacta Recalls GMK Knee System Inserts Due to Screw Back-Out Risk

    Medacta is recalling 12,768 GMK knee system inserts nationwide due to a reported 0.1% occurrence rate of post-operative screw back-out.

    Product
    The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0256-2018·2017-12-27

    Terumo Overpressure Safety Valve Recalled Due to No Flow Reports

    Terumo CVS is recalling 297,222 Overpressure Safety Valves worldwide after receiving reports of no flow through the device.

    Product
    TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·18069·2017-12-27

    Rocky Mountain Bicycles Recall Mountain Bikes Due to Crash Hazard

    Rocky Mountain Bicycles is recalling 2018 Altitude, Instinct, and Pipeline models because improperly secured brake cable housing can cause brake failure and crashes.

    Product
    Mountain bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0280-2018·2017-12-27

    Zimmer Dental Surgical Kits Recalled for Manufacturing Defect

    Zimmer Dental Inc. is recalling 30 surgical kits because a manufacturing defect may prevent the driver from properly engaging dental implants.

    Product
    Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or…
    Category
    Medical Device
    Distribution
    Distributed nationwide