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.

39551–39575 of 50506

  • HighFDA (Devices)·Z-1087-2015·2015-02-18

    Siemens Symbia T Series Medical Imaging Systems Recalled for Bearing Failure

    Siemens Medical Solutions is recalling Symbia T series imaging systems because a linear bearing car may fail, allowing ball bearings to fall out.

    Product
    The Siemens Symbia T series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1101-2015·2015-02-18

    Teleflex Medical Recalls Aquapak 340 Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling Aquapak 340 Humidifier Adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1102-2015·2015-02-18

    Teleflex Medical Recalls Aqua 540 Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling Aqua 540 Humidifier Adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1084-2015·2015-02-18

    Integra Recalls Mayfield Ultra 360 Base Units Due to Locking Handle Failure

    Integra LifeSciences is recalling 1,053 Mayfield Ultra 360 Base Units because the locking handle mechanism may fail during use, posing a risk to patients.

    Product
    The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1086-2015·2015-02-18

    Siemens Symbia S Series Medical Imaging Systems Recalled for Bearing Failure

    Siemens Medical Solutions is recalling 719 Symbia S series systems because a linear bearing car may fail, allowing ball bearings to fall out.

    Product
    The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1107-2015·2015-02-18

    Teleflex Medical Recalls 040 Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling 040 Humidifier Adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    ADAPTOR, 040 HUM, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15E009000·2015-02-18

    Gillig Recalls S26 Eaton Hydraulic Pumps for Steering Effort Changes

    Gillig LLC is recalling 177 S26 Eaton-brand hydraulic pumps sold between 2011 and 2014. The pumps may have manufacturing inconsistencies causing unexpected steering effort changes.

    Product
    STEERING:HYDRAULIC POWER ASSIST:PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1104-2015·2015-02-18

    Teleflex Medical Recalls Aquapak Sterile Water Adaptors for Foreign Material

    Teleflex Medical is recalling Aquapak sterile water humidifier adaptors because packages may contain black particles.

    Product
    AQUAPAK SW/EAU STERILE, 650 ML W/ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1066-2015·2015-02-18

    Damon Industries Recalls Bloody Mary Concentrate Due to Undeclared Anchovies

    Damon Industries is recalling 87 gallons of Southern Supreme Spicy Tabasco Bloody Mary Beverage Concentrate because it contains undeclared anchovies.

    Product
    Southern Supreme Spicy Tabasco Bloody Mary Beverage Concentrate; 2 + 1 packed in 3 gal Bag in Box. UPC - 7 0073 22603 0; Manufactured by Damon Industries, Sparks, NV
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1043-2015·2015-02-18

    Son In Law BBQ Sauces Recalled for Undeclared Anchovies

    Son In Law Products is recalling three varieties of BBQ sauce because they contain anchovies that are not listed on the label.

    Product
    Honey Horseradish BBQ Sauce
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1063-2015·2015-02-18

    Siemens ACUSON S2000 Breast Scanner Recall for Detachment Risk

    Siemens is recalling 24 ACUSON S2000 breast scanners because the scanner arm may detach from the column.

    Product
    ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1065-2015·2015-02-18

    Damon Industries Recalls Bloody Mary Concentrate Due to Undeclared Anchovies

    Damon Industries is recalling Bloody Mary Premium Beverage Concentrate because it contains undeclared anchovies, a major allergen.

    Product
    Fruitful Juice Product Bloody Mary Premium, Beverage Concentrate; Contains 54% Juice; 2 + 1 packed in 3 gal Bag in Box. UPC - 7 0073 08203 2; Manufactured by Damon Industries, Sparks, NV
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1083-2015·2015-02-18

    MedComp Recalls Hemodialysis Catheters and PICCs Due to Sterilization Error

    Medical Components, Inc dba MedComp is recalling 243 hemodialysis catheters and PICCs because a duplicate sterilization process may have rendered included drug products ineffective.

    Product
    Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH), MRCTP41017 (4F X 55CM SINGLE CT PICC), MRCTP52007 (5F DUAL PRO-PICC NURSING TRAY), MRCTP52010 (5F DUAL PRO-PICC MAX BARR TRAY)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1111-2015·2015-02-18

    Arthrosurface Shoulder Prosthetic Components Recalled for Marketing Clearance Issues

    Arthrosurface, Inc. is recalling 143 Taper Post Fixation Components because they were not cleared for marketing in the US with current indications.

    Product
    Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1106-2015·2015-02-18

    Teleflex Medical Recalls Aquapak 640 SW Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling Aquapak 640 SW humidifier adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1099-2015·2015-02-18

    Teleflex Medical Recalls Aquapak Sterile Water Adaptors for Foreign Material

    Teleflex Medical is recalling Aquapak sterile water humidifier adaptors because packages may contain black foreign particles.

    Product
    AQUAPAK SW/EAU STERILE, 340 ML W/ADAPTOR Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1103-2015·2015-02-18

    Teleflex Medical Recalls AQUAPAK 640 SW Humidifier Adaptors for Foreign Material

    Teleflex Medical is recalling AQUAPAK 640 SW humidifier adaptors because packages may contain black particles. The recall covers 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 640 SW, 650ML W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1067-2015·2015-02-18

    Mt. Rose Bloody Mary Mix Recalled for Undeclared Anchovy Allergen

    Mt. Rose Drinks is recalling Bloody Mary mixes because Worcestershire sauce contains anchovies not listed on the label.

    Product
    Mt. Rose Drinks Bloody Mary and Mt. Rose The Lakes Country Club Bloody Mary; 32 oz. glass bottles, 12 per case packed in 3 gal Bag in Box. UPC - Mt. Rose Drinks 7 0073 85212 3; UPC Mt. Rose The Lakes 7 00073 85275 8 Manufactured and distributed by Mt. Rose Drinks…
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·15E010000·2015-02-18

    Gillig Recalls S5510 Wheelchair Lifts Due to Platform Cracking Risk

    Gillig LLC is recalling S5510 series wheelchair lifts manufactured by Ricon Corporation between November 2010 and February 2011. The platform side plates may crack, posing a risk of injury if the platform falls.

    Product
    EQUIPMENT ADAPTIVE/MOBILITY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1029-2015·2015-02-18

    MorningStar Farms Spicy Black Bean Burgers Recalled for Undeclared Peanut

    Kellogg USA Inc is recalling MorningStar Farms Spicy Black Bean Burgers because they contain undeclared peanut protein.

    Product
    MorningStar Farms Spicy Black Bean Burger: 9.50 oz (4 ct) - UPC 2898939207; 18.90 oz (8 ct): UPC 2898971750; 8.7 lb case (48 ct): UPC 2898949938; 9.75 lb case (4 sleeve): UPC 2898997765; 12.75 lb case (4 sleeve): UPC 2898931651
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1199-2015·2015-02-18

    El Campestre Seasoning Products Recalled for Undeclared Dyes

    El Campestre, Inc. is recalling Chicken Sasonador, Beef Sasonador, and Adobo Mix due to undeclared Yellow #5 and Yellow #6 dyes.

    Product
    El Campestre Chicken Sasonador Ingredients: Water, Salt, Orange Juice Concentrate, Paprika, Guar Gum, Vinegar, Bijol, Garlic, Onion, Spices, Sugar, 0.1% Sodium Benzoate, and Potassium Sorbate NET WT. 1 GAL. (3.79L) After Opening Keep Refrigerated Ingredients: Water…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1200-2015·2015-02-18

    El Campestre Seasoning Products Recalled for Undeclared Dyes

    El Campestre, Inc. is recalling Chicken Sasonador, Beef Sasonador, and Adobo Mix due to undeclared Yellow #5 and Yellow #6 dyes.

    Product
    El Campestre Beef Sasonador NET WT. 1 GAL. (3.79L) After Opening Keep Refrigerated Ingredients: Water, Salt, Orange Juice Concentrate, Lemon Juice Concentrate, Vinegar, Paprika, Garlic, Onion, Spices, Sugar, 0.1% Sodium Benozoate, and Potassium Sorbate. 0 89239…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1109-2015·2015-02-18

    Teleflex Medical Recalls Aquapak 640 SW Humidifier Adaptors for Foreign Material

    Teleflex Medical is recalling Aquapak 640 SW humidifier adaptors because packages may contain black particles. The recall covers 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1096-2015·2015-02-18

    Teleflex Medical Recalls Aquapak 101 SW Humidifier Adaptors for Foreign Material

    Teleflex Medical is recalling Aquapak 101 SW humidifier adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
    Category
    Medical Device
    Distribution
    Distributed nationwide