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.

45476–45500 of 50512

  • HighFDA (Food)·F-1646-2012·2012-07-04

    Bay Valley Foods Recalls Pasta Mix Due to Metal Fragments

    Bay Valley Foods is voluntarily recalling boxed pasta mix products because they contain a seasoning blend that may have small metal fragments.

    Product
    H.E.B Pasta Salad Ranch & Bacon, NET WT 7.5 OZ , CONT. NET 212G, UPC 4122089106
    Category
    Food
    Distribution
    25 states
  • HighFDA (Food)·F-1647-2012·2012-07-04

    Bay Valley Foods Recalls Macaroni and Cheese for Metal Fragments

    Bay Valley Foods is voluntarily recalling Kroger Macaroni & Cheese products because they contain a seasoning blend that may have small metal fragments.

    Product
    Kroger, Macaroni & Cheese Rich n Creamy, NET WT 7.25 OZ (205 g), UPC 1111085149, DISTRIBUTED BY KROGER CO, CINCINNATI, OH 45202.
    Category
    Food
    Distribution
    25 states
  • HighFDA (Devices)·Z-1894-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannula Kits Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannula kits because a foreign substance on the cannula tips can be dislodged during use.

    Product
    CPB CATHETER KIT-DR BARTLES Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1888-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannula Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulae because a foreign substance was found on the inner surface of some tips that could be dislodged.

    Product
    CUSTOM CPB CATHETER KIT-DR. Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1650-2012·2012-07-04

    Bay Valley Foods Recalls Macaroni and Cheese for Metal Fragments

    Bay Valley Foods is voluntarily recalling Great Value Macaroni and Cheese because the seasoning blend may contain small metal fragments.

    Product
    Great Value, Thick and Creamy Macaroni and Cheese , NET WT 7.25 OZ (206g), UPC 7874223061, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716
    Category
    Food
    Distribution
    25 states
  • HighFDA (Food)·F-1642-2012·2012-07-04

    Bay Valley Foods Recalls Pasta Mixes Due to Metal Fragments

    Bay Valley Foods is voluntarily recalling approximately 74,000 cases of boxed pasta mix products because they contain a seasoning blend that may have small metal fragments.

    Product
    Reggano, Linguine and Parmesan Pasta Entree, NET WT 4.8 OZ(136g), UPC 4149813345, Distributed by ALDI Inc., Batavia, IL 60510.
    Category
    Food
    Distribution
    25 states
  • HighFDA (Devices)·Z-1876-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some tips that can be dislodged.

    Product
    SARNS ANTEGRADE: CARDIOPLEGIA CANNULA: ROOT INFUSION VENT/CATHETER WITH 14- GAUGE WHITE NEEDLE, RECTANGULAR FLANGE, 6" (15 CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1644-2012·2012-07-04

    Bay Valley Foods Recalls Reggano Pasta Skillet Dinner Due to Metal Fragments

    Bay Valley Foods is voluntarily recalling Reggano Pasta Skillet Dinner Stroganoff because the seasoning blend may contain small metal fragments.

    Product
    Reggano Pasta Skillet Dinner Stroganoff, NET WT 5.6 OZ (158 g) UPC 4149812433, Distributed by ALDI Inc., Batavia, IL 60510
    Category
    Food
    Distribution
    25 states
  • HighFDA (Devices)·Z-1858-2012·2012-07-04

    Hartmann Sterilux Gauze Sponges Recalled for Sterile Barrier Defects

    Hartmann USA is recalling Sterilux gauze sponges because micro holes were found in the sterile barrier, potentially compromising sterility.

    Product
    Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1869-2012·2012-07-04

    Siemens B12 Reagent Cartridges Recalled for False Test Results

    Siemens is recalling B12 Flex reagent cartridges because Intrinsic Factor Blocking Antibodies can cause false high Vitamin B12 results.

    Product
    Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1865-2012·2012-07-04

    GE OEC Uroview 2800 Recalled for Intermittent Safety Issues

    GE OEC Medical Systems is recalling 717 OEC Uroview 2800 fluoroscopic imaging systems due to intermittent safety issues, including navigation tracking inaccuracy and system lock-ups.

    Product
    OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1896-2012·2012-07-04

    Philips HeartStart MRx Monitor/Defibrillators Recalled for ECG Failure

    Philips is recalling HeartStart MRx monitor/defibrillators because they may fail to display ECG signals, potentially delaying the treatment of cardiac arrhythmias.

    Product
    Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1889-2012·2012-07-04

    Terumo Recalls Sarns Cardioplegia Cannula Kits Due to Foreign Substance

    Terumo is recalling Sarns Cardioplegia Cannula Kits because a foreign substance was found on the inner surface of some cannula tips that could be dislodged.

    Product
    CPB CATHETER KIT-DR GERHARDT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1882-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannula Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some tips that could dislodge.

    Product
    X-COATED TRANSPLANT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1866-2012·2012-07-04

    Stryker Endoscopy Recalls Formula Shaver Handpieces Due to Routine Check Concerns

    Stryker Endoscopy is recalling 34 Formula and Formula 180 Shaver Handpieces because routine checks to ensure accuracy and fitness for use may not have been adequately determined.

    Product
    Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1877-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some tips that could be dislodged.

    Product
    SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1885-2012·2012-07-04

    Terumo Recalls Sarns Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some tips that can be dislodged.

    Product
    MAYO MN XCOATED 3/8X1/2 AV Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2012·2012-07-04

    Colgate 360 Toothbrush Recalled Due to Battery Cap Defect

    Colgate-Palmolive is recalling 280,044 units of Colgate 360 battery-powered toothbrushes because the battery cap may blow off the handle.

    Product
    Colgate 360 Replaceable Head Battery Powered Toothbrush Soft UPC 03500068747 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1881-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannula Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulae because a foreign substance was found on the inner surface of some tips that could be dislodged.

    Product
    XC HEART/LUNG PACK W/SX25RX Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1641-2012·2012-07-04

    Pasta Roni Recalled for Potential Metal Fragment Contamination

    Quaker Foods and Snacks North America is recalling specific Pasta Roni products due to potential metal fragment contamination in an ingredient.

    Product
    Pasta Roni Parmesan Cheese Flavor angel hair pasta in a Parmesan sauce with other natural flavors; Net Wt. 5.1 oz. box/12 boxes/case; Distributed by Golden Grain Co., P.O. Box 049003, Chicago, IL 60604-9903; UPC 0 15300 44049
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1859-2012·2012-07-04

    Stryker Recalls GoBed+ Model FL20E Hospital Beds Due to Scale Failures

    Stryker is recalling 6,325 GoBed+ Model FL20E hospital beds worldwide because loadcell failures can cause scale errors or disable bed exit functions.

    Product
    GoBed+ . Model FL20E Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1887-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some tips that can be dislodged.

    Product
    X-COATED H/L PK W/FX15RW40 Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1872-2012·2012-07-04

    Colgate 360 Toothbrush Recalled Due to Battery Cap Defect

    Colgate-Palmolive is recalling 280,044 Colgate 360 battery-powered toothbrushes because the battery cap may blow off the handle.

    Product
    Colgate 360 Replaceable Head Battery Powered Toothbrush Medium UPC03500068750 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1654-2012·2012-07-04

    PGP International Recalls iForce Nutrition Protein Powder for Undeclared Wheat

    PGP International is recalling iForce Nutrition PROTEAN Lean Protein powder because it contains undeclared wheat. The product was distributed in California, North Carolina, and Wisconsin.

    Product
    iForce Nutrition Xtreme Series, PROTEAN, Lean Protein, Strawberry Creamsicle, Dietary Supplement, 4 lbs. Mfg. for Dist by, Tribravus Enterprises, LLC, Vista, CA 92081
    Category
    Food
    Distribution
    3 states