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.

42551–42575 of 50511

  • HighFDA (Food)·F-0112-2014·2013-11-13

    Martha White Corn Meal Recalled for Aflatoxin Levels Exceeding FDA Limits

    J M Smucker Co is recalling specific lots of Martha White Corn Meal because independent testing found aflatoxin levels above FDA specifications.

    Product
    Martha White Corn Meal Plain, White, Enriched NET WT 32 OZ (2 LB) 907g Paper Bag Mfg Code 3193 511 BEST IF USED BY: 12-Mar-14 Product labeled in part, INGREDIENTS: WHITE CORN MEAL, NIACIN, IRON, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID*** MAY CONTAIN MILK AND WHEAT…
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-0148-2014·2013-11-13

    Fresenius Liberty Cycler Recalled for Fluid Leak and Contamination Risk

    Fresenius Medical Care is recalling Liberty Cyclers because fluid leaks may contaminate dialysate, potentially causing peritonitis.

    Product
    Fresenius Liberty¿ Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0126-2014·2013-11-13

    Safeway Angel Food Cake Recalled for Missing Soy Flour Labeling

    Safeway is recalling Angel Food Cake Fruit Topped because the ingredient label omitted soy flour, a major allergen.

    Product
    Angel Food Cake Fruit Topped; labeled for retail sale in the following stores: Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons. Angel Food Cake Fruit Topped  3 lb. 12 oz. (1701 g); Angel Food Cake Fruit Topped  Black or White…
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-0141-2014·2013-11-13

    Steris Harmony Equipment Management System Recalled for Drive Screw Failure Risk

    Steris Corporation is recalling 127 Harmony Equipment Management Systems because a drive screw in the ceiling supply unit may break, causing the adjustable arm to drop.

    Product
    Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are used in hospital facilities to provide ready access to medical gasses, electrical power and audio/visual data services, in addition to managing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V565000·2013-11-13

    Sutphen Fire Apparatus Recall for Ladder Bearing Defect

    Sutphen is recalling specific fire apparatus models because ladder extension bearings may seize, causing cables to fail and the aerial to retract unexpectedly.

    Product
    SUTPHEN — SUTPHEN SPH 100, SP 110, SPI 112, SAI 110
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0170-2014·2013-11-13

    Hamilton Medical Recalls HAMILTON-C2 Ventilators Due to Loudspeaker Defects

    Hamilton Medical is recalling 316 HAMILTON-C2 ventilators because the alarm system loudspeakers exceeded manufacturer-defined limits for improper functioning.

    Product
    HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0135-2014·2013-11-13

    Edwards Lifesciences Recalls Aortic Perfusion Cannulas Due to Cracks

    Edwards Lifesciences is recalling two lots of aortic perfusion cannulas because cracks were found in the t-connectors during product evaluation.

    Product
    Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only, Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V567000·2013-11-13

    GM Recalls 2014 Chevrolet Malibu for Defroster Software Defect

    General Motors is recalling 2014 Chevrolet Malibus because the HVAC control may fail, preventing the windshield defroster from working and reducing visibility.

    Product
    CHEVROLET — CHEVROLET MALIBU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0151-2014·2013-11-13

    Ethicon Adjustable Gastric Band Recalled for Force to Lock Failure

    Ethicon Endo-Surgery Inc is recalling 1,248 units of Adjustable Gastric Bands because they failed to meet Force to Lock requirements during aging studies.

    Product
    Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0168-2014·2013-11-13

    Roche COBAS INTEGRA 800 Analyzer Recalled for Software Maintenance Defect

    Roche Diagnostics is recalling 527 COBAS INTEGRA 800 Analyzers with software version 9864.C2 because the system fails to perform necessary ISE service actions and maintenance requests.

    Product
    COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory A fully automated system for clinical chemistry analysis intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2014·2013-11-13

    Invacare Aquatec Ocean Mobile Shower and Toilet Commode Recall

    Invacare is recalling Aquatec Ocean mobile shower and toilet commodes because backrest cushion fixtures may unlatch in reclined or tilted positions.

    Product
    Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet commode with tilting function. Mobile shower and toilet commode with tilting function
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0143-2014·2013-11-13

    Baxter Recalls Dual Luer Lock Caps Due to Loose Particulate Matter

    Baxter Healthcare is recalling specific lots of Dual Luer Lock Caps because loose particulate matter was found in the packaging, posing a risk of embolic events.

    Product
    Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0114-2014·2013-11-13

    Martha White Cornbread Recalled for Aflatoxin Contamination

    J M Smucker Co is recalling specific lots of Martha White Cotton Country Cornbread because aflatoxin levels exceeded FDA specifications.

    Product
    Martha White Cotton Country Cornbread, NET WT 6 OZ (170g) Paper Bag Mfg Code 3107 501 BEST IF USED BY: 17-Apr-14 Product labeled in part, INGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, ENRICHED BLEACHED FLOUR***PARTIALLY HYDROGENATED SOYBEAN OIL, DEXTROSE, BAKING POWDER***…
    Category
    Food
    Distribution
    33 states
  • HighFDA (Food)·F-0110-2014·2013-11-13

    White Lily Cornmeal Mix Recalled for Aflatoxin Contamination

    J M Smucker Co is recalling White Lily Enriched White Cornmeal Mix because aflatoxin levels exceeded FDA specifications.

    Product
    WHITE LILY¿ ENRICHED WHITE Cornmeal MIX SELF-RISING NET WT 32 OZ (2 LB) 907g Paper Bag Mfg Code 3135 511 BEST IF USED BY: 15-JAN-14 Product labeled in part, INGREDIENTS: ENRICHED WHITE CORN MEAL, WHEAT FLOUR AND DEGERMINATED WHITE CORN MEAL***BAKING POWDER***SALT***CONTAINS…
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-0139-2014·2013-11-13

    Intuitive Surgical Recalls da Vinci Patient Carts Due to Fluid Complaints

    Intuitive Surgical is recalling 1,754 da Vinci S and SI Patient Carts worldwide due to increased complaints about fluid entering the cart base.

    Product
    Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Patient Side Cart (PSC) is a robotic platform used for da Vinci Surgery. It is the operative component for both da Vinci systems and…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0105-2014·2013-11-13

    Martha White Self-Rising Corn Meal Recalled for Aflatoxin Contamination

    J M Smucker Co is recalling specific lots of Martha White Self-Rising Corn Meal because aflatoxin levels exceeded FDA specifications.

    Product
    Martha White¿ SELF-RISING Corn Meal Bolted White Enriched Hot Rize Net Wt 5 lb (2.26 kg) Paper bag, Mfg Code 3127 511 BEST IF USED BY: 7-Jan-14, Product labeled in part, INGREDIENTS: ENRICHED BOLTED WHITE CORN MEAL***BAKING POWDER***SALT***DISTRIBUTED BY: MARTHA WHITE FOODS…
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-0149-2014·2013-11-13

    Ethicon Endo-Surgery Recalls Adjustable Gastric Bands Due to Locking Failure

    Ethicon Endo-Surgery Inc is recalling adjustable gastric bands because they failed to meet force-to-lock requirements during aging studies.

    Product
    Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with one band per kit. Product Usage: Intended for use in surgical treatment of morbid obesity
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0107-2014·2013-11-13

    Martha White Cornbread Mix Recalled for Aflatoxin Contamination

    J M Smucker Co is recalling specific lots of Martha White Buttermilk Cornbread & Muffin Mix because aflatoxin levels exceeded FDA specifications.

    Product
    Martha White¿ Buttermilk Cornbread & Muffin Mix NET WT 6 OZ (170g) Laminated Pouch Mfg Code 3105 501 BEST IF USED BY: 15 APR 14 Product labeled in part INGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, WHEAT FLOUR*** PARTIALLY DEHYDROGENATED SOYBEAN OIL, DEXTROSE, BAKING…
    Category
    Food
    Distribution
    33 states
  • HighFDA (Food)·F-0108-2014·2013-11-13

    Martha White Cornbread Mix Recalled for Aflatoxin Contamination

    J M Smucker Co is recalling specific lots of Martha White Cotton Country Cornbread Mix because independent testing found aflatoxin levels exceeding FDA specifications.

    Product
    Martha White¿¿ COTTON COUNTRY CORNBREAD BUTTERMILK CORNBREAD MIX NET WT 6 OZ (170g) Laminated Pouch Mfg Code 3106 501 BEST IF USED BY: 16 APR 14 & Mfg Code 3107 501 BEST IF USED BY: 17 APR 14 Product labeled in part, ¿¿SINGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, AND…
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-0169-2014·2013-11-13

    Vital Images Recalls VitreaCore Software Due to Image Orientation Defect

    Vital Images, Inc. is recalling VitreaCore software versions 6.0 through 6.5 due to a potential for incorrect or reversed image orientation in certain snapshots.

    Product
    VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. The VitreaCore (ViTALConnect) system is a medical diagnostic software system intended to process, analyze…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0103-2014·2013-11-13

    Jim Dandy Iron Fortified Quick Grits Recalled for Aflatoxin Contamination

    J M Smucker Co is recalling Jim Dandy Iron Fortified Quick Grits because independent testing found aflatoxin levels exceeding FDA specifications.

    Product
    Jim Dandy¿ Iron Fortified Quick Grits, 1lb paper box, Labeled in part "INGREDIENTS: IRON, WHITE CORN GRITS, NIACIN, THIAMIN, MONONITRATE, RIBOFLAVIN, FOLIC ACID. DISTRIBUTED BY: MARTHA WHITE FOODS, INC., P. O. BOX 751030 MEMPHIS, TN 38175***0 13300 11501 5***3067 511 Best If…
    Category
    Food
    Distribution
    33 states
  • HighNHTSA·13V566000·2013-11-13

    GM Recalls 2013 Chevrolet Malibu for Power Seat Wiring Fire Risk

    General Motors is recalling 2013 Chevrolet Malibus with 8-way power seats because the wiring harness may chafe, potentially causing a short circuit or fire.

    Product
    CHEVROLET — CHEVROLET MALIBU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0104-2014·2013-11-13

    Jim Dandy Enriched Quick Grits Recalled for Aflatoxin Contamination

    J M Smucker Co is recalling Jim Dandy Enriched Quick Grits because independent testing found aflatoxin levels exceeding FDA specifications.

    Product
    Jim Dandy¿ Enriched Quick Grits, 1lb paper box, Labeled in part INGREDIENTS: WHITE CORN GRITS***NACIN, THIAMIN, MONONITRATE, RIBOFLAVIN, FOLIC ACID. DISTRIBUTED BY: MARTHA WHITE FOODS, INC., P. O. BOX 751030 MEMPHIS, TN 38175***0 13300 12107 8***3143 511 BEST IF USED BY…
    Category
    Food
    Distribution
    33 states