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.

41701–41725 of 50511

  • HighFDA (Devices)·Z-1092-2014·2014-03-05

    Zimmer Trabecular Metal Shoulder Humeral Stem Recalled for Bond Strength Defect

    Zimmer, Inc. is recalling 10 units of Trabecular Metal Shoulder Humeral Stems because testing found bond strength below the minimum required specification in one zone.

    Product
    00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem Length Trabecular Metal Humeral Stem 48 Degree 11mm x 130mm, Sterile, QTY 1, Rx Product Usage: Zimmer Trabecular Metal TM Humeral Stem is a shoulder…
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·14E006000·2014-03-05

    Meritor Wabco Recalls Trailer Spring Brake Control Valves

    Meritor Wabco is recalling specific trailer spring brake control valves sold as replacement parts because the intake/exhaust valve may come apart, preventing the parking brake from engaging.

    Product
    PARKING BRAKE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2014·2014-03-05

    Elekta Recalls DMLC IV-ERGO Systems Due to Gantry Sensor Error

    Elekta, Inc. is recalling 35 DMLC IV-ERGO systems because an intermittent error may occur in the gantry sensor. The devices are used with linear accelerators for radiation therapy.

    Product
    DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1118-2014·2014-03-05

    Philips HeartStart MRx Monitor/Defibrillator Recalled for ECG Cable Wear

    Philips is recalling HeartStart MRx Monitor/Defibrillators because the ECG trunk cable and connector block may wear prematurely, causing an interrupted ECG signal.

    Product
    Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC. Used for the termination of ventricular tachycardia and ventricular fibrillation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1580-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Cakes for Undeclared Wheat

    E. Franco & Co. Inc is recalling Brazo gitano (rolled cake) with bavarian cream filling due to undeclared wheat allergens. The product was distributed in Puerto Rico.

    Product
    "***Brazo gitano (rolled cake)***bavarian cream cake filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1562-2014·2014-03-05

    Newman's Own Salsa Con Queso Recalled for Undeclared Wheat

    Newman's Own is recalling Salsa Con Queso, Medium All Natural, 16 oz. jars nationwide due to undeclared wheat.

    Product
    Newman's Own Salsa Con Queso, Medium All Natural Net Wt.16 oz., packaged in a glass jar UPC 0 20662 00353 9
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1573-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Cakes for Undeclared Wheat

    E. Franco & Co. Inc. is recalling Brazo gitano (rolled cake) with pumpkin paste filling because it contains undeclared wheat. The product was distributed in Puerto Rico.

    Product
    "***Brazo gitano (rolled cake)***pumpkin paste filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1581-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Cakes for Undeclared Wheat

    E. Franco & Co. Inc is recalling approximately 2,300 rolls of Brazo Gitano lemon filling cakes sold in Puerto Rico due to undeclared wheat.

    Product
    "***Brazo gitano (rolled cake)***lemon filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1561-2014·2014-03-05

    Creation Special Snack Mix Recalled for Missing Allergen Labeling

    Creation Gardens is recalling Creation Special Snack Mix because the packaging lacks required ingredient and allergen statements, including peanuts, tree nuts, soy, and wheat.

    Product
    Creation Special Snack Mix 25 lb plastic bags in a cardboard box. Box labeled "DAYTON'S ESTABLISHED 1923 DAYTON NUT SPECIALTIES, INC. 919 N. MAIN DAYTON, OHIO 45405" with a white stick on label which reads, "25# CREATION SPECIAL MIX
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1114-2014·2014-03-05

    Winco Premier Care Recliner 5570 Recalled for Lock Bar Defect

    Winco Mfg. is recalling 369 Premier Care Recliner 5570 units due to a manufacturing defect that may cause the lock bar to fail.

    Product
    PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or Heat & Massage, OPTIONAL LiquiCell. The products are a multi position recliners with a steel frame used primarily in long term care or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1576-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Rolls for Undeclared Wheat

    E. Franco & Co. is recalling Brazo Gitano rolled cakes with coconut filling because they contain undeclared wheat. The product was distributed in Puerto Rico.

    Product
    "***Brazo gitano (rolled cake)***coconut filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1120-2014·2014-03-05

    Philips HeartStart MRx Defibrillator Batteries Recalled for Shutdown Risk

    Philips is recalling 43,792 HeartStart MRx defibrillator batteries because they may shut down unexpectedly when exposed to high electromagnetic interference.

    Product
    HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1582-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Cakes for Undeclared Wheat

    E. Franco & Co. Inc is recalling Brazo gitano (rolled cake) with guava-cheese filling because it contains undeclared wheat.

    Product
    "***Brazo gitano (rolled cake)***guava-cheese filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1097-2014·2014-03-05

    Ossur Recalls Symbionic Leg Due to Battery Warning Failure

    Ossur is recalling 144 Symbionic Leg prosthetics because they fail to display a low battery warning before powering down.

    Product
    The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1553-2014·2014-03-05

    Popcorn Factory Recalls Heart-Shaped Popcorn Balls Due to Missing Allergen Labels

    The Popcorn Factory is recalling heart-shaped popcorn balls because the Nutrition Facts and allergen labels were not applied to the individual pieces. The product contains milk and soy allergens.

    Product
    Candy coated popcorn shaped into a heart weighing 1.5 ounces per piece and individually wrapped in clear plastic packaging. There are 24 popcorn balls per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1066-2014·2014-03-05

    Smith & Nephew Recalls Reflection Interfit Shell Due to Undersized Radius

    Smith & Nephew is recalling 10 units of Reflection Interfit Shells because the inner spherical radius is undersized. The affected devices were distributed in the US and internationally.

    Product
    Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1099-2014·2014-03-05

    Fresenius Optiflux F160NR Dialyzers Recalled for Dialysate Port Leak

    Fresenius Medical Care is recalling Optiflux F160NR dialyzers because the dialysate port may leak during priming. The recall covers 6,720 units distributed in the US and Mexico.

    Product
    Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1075-2014·2014-03-05

    Radiometer D788 pCO2 Membranes Recalled for Biased Measurement Results

    Radiometer America is recalling D788 pCO2 membranes because they may cause biased measurement results for patients and quality control.

    Product
    pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1585-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Cakes for Undeclared Wheat

    E. Franco & Co. Inc is recalling Brazo Gitano rolled cakes with chocolate filling due to undeclared wheat. The product was distributed in Puerto Rico.

    Product
    "***Brazo gitano (rolled cake)***chocolate filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1108-2014·2014-03-05

    Philips HeartStart MRx Defibrillators Recalled for Wireless Data Transmission Defect

    Philips is recalling 220 HeartStart MRx defibrillators because the Wireless Link upgrade may fail to transmit data in specific configurations.

    Product
    M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by…
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1106-2014·2014-03-05

    Fresenius Recalls Optiflux F18Nre Dialyzers Due to Port Leak Risk

    Fresenius Medical Care is recalling 34,752 Optiflux F18Nre Flux Dialyzers because the dialysate port may leak during priming.

    Product
    Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1579-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Rolls for Undeclared Wheat

    E. Franco & Co. Inc is recalling approximately 2,300 14-ounce rolls of Brazo Gitano with chocolate cake filling distributed in Puerto Rico due to undeclared wheat.

    Product
    "***Brazo gitano (rolled cake)***chocolate cake filling***"
    Category
    Food
    Distribution
    1 state