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.

37301–37325 of 50506

  • HighFDA (Devices)·Z-0160-2016·2015-11-04

    LifeHealth Recalls BG Cartridges for IRMA TRUPOINT Blood Gas Analyzer

    LifeHealth is recalling BG cartridges for the IRMA TRUPOINT Blood Gas Analyzer because the pH sensor may provide falsely elevated results as the product ages.

    Product
    BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint¿ Blood Analysis System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0106-2016·2015-11-04

    Kermit's Chipotle Key Lime Barbecue Sauce Recalled for Undeclared Soy

    Kermit, Inc. is recalling 16 oz bottles of Chipotle Key Lime Barbecue Sauce due to undeclared soy on the label.

    Product
    Kermit's Chipotle Key Lime Barbecue Sauce, 16 oz, Key West, FL, UPC 091920850929
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0159-2016·2015-11-04

    LifeHealth Recalls IRMA TRUPOINT Blood Gas Analyzer CC Cartridges

    LifeHealth, LLC is recalling IRMA TRUPOINT Blood Gas Analyzer CC Cartridges because the pH sensor may provide falsely elevated results as shelf life progresses.

    Product
    CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint¿ Blood Analysis System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V729000·2015-11-04

    MobilityWorks Recalls Ford Vans with Defective Ricon Wheelchair Lifts

    MobilityWorks is recalling 667 Ford E-series vans equipped with specific Ricon wheelchair lifts. Defective pivot holes may allow bearings to shift, causing the lift platform to fall and injure the operator.

    Product
    FORD — FORD E-250, E-150, E-350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0105-2016·2015-11-04

    Kermit's Hot & Spicy Key Lime Barbecue Sauce Recalled for Undeclared Soy

    Kermit, Inc. is recalling 16 oz bottles of Hot & Spicy Key Lime Barbecue Sauce due to undeclared soy on the label.

    Product
    Kermit's Hot & Spicy Key Lime Barbecue Sauce, 16 oz, Key West, FL, UPC 116601501423 & 802468905312
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0162-2016·2015-11-04

    Materialise Recalls Patient-Specific Knee Surgical Guides Due to Alignment Inaccuracies

    Materialise N.V. is recalling four patient-specific surgical guides for knee arthroplasty because image data processing errors led to inaccurate surgical planning.

    Product
    Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0185-2016·2015-11-04

    FDA Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 80 custom cardiovascular surgical kits because compromised package integrity may affect sterility assurance.

    Product
    Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0108-2016·2015-11-04

    Kermit's Key Lime Ginger Wasabi Marinade Recalled for Undeclared Soy and Wheat

    Kermit, Inc. is recalling 455 bottles of Key Lime Ginger Wasabi Marinade because the label fails to list soy and wheat ingredients.

    Product
    Kermit's Key Lime Ginger Wasabi Marinade, 12 oz, Key West, FL, UPC 070820060706 & 802468905480
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0139-2016·2015-11-04

    Moses Lake Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    JD & SN Inc. is recalling 13 vials of 80 mg testosterone pellets because the FDA cannot ensure the sterile compounded drugs are free from contamination.

    Product
    TESTOSTERONE, Pellet, 80 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2016·2015-11-04

    FDA Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 153 custom cardiovascular surgical kits because compromised package integrity may affect sterility assurance.

    Product
    Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0126-2016·2015-11-04

    Moonstruck Chocolate Nuts and Chews Recalled for Undeclared Sulfite

    Moonstruck Chocolate Company is recalling 253 boxes of 9pc Nuts & Chews Collection due to undeclared sulfite. The product was distributed in 14 states and online.

    Product
    Moonstruck Chocolates 9 piece Nuts & Chews Collection. The box contains 9 different nut and chews, various shapes, in 9 different flavors. Net Wt. 5.19oz (147g). Item Number: 310896, UPC: 7 11175 10896 4.
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-0166-2016·2015-11-04

    Perkin Elmer Specimen Gate Software Recall for Incorrect Result Interpretation

    Perkin Elmer is recalling Specimen Gate software because abnormal newborn screening test results may be incorrectly interpreted as normal.

    Product
    Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0101-2016·2015-11-04

    Kermit's Key Lime Cocktail Sauce Recalled for Undeclared Soy

    Kermit, Inc. is recalling 12-ounce bottles of Key Lime Cocktail Sauce due to undeclared soy on the label.

    Product
    Kermit's Key Lime Cocktail Sauce, 12 oz, Key West, FL, UPC 007172006076 & 0802468905503
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0193-2016·2015-11-04

    Integra Bone Marrow Biopsy Trays Recalled Due to Lidocaine Particulate

    Integra is recalling Bone Marrow Biopsy Trays because they contain Hospira Lidocaine vials with visible particulate matter.

    Product
    Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % Lidocaine HCL Injection, USP, 10 mg/mL (manufactured and…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0179-2016·2015-11-04

    Encore Medical Recalls Turon Shoulder Impaction Fixtures Due to Material Wear

    Encore Medical is recalling 277 Turon Shoulder Impaction Fixtures because polymer material wore off during assembly, potentially contaminating the implant.

    Product
    Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0107-2016·2015-11-04

    Kermit's P4 Hot Sauce Recalled for Undeclared Soy Allergen

    Kermit, Inc. is recalling Kermit's P4 Hot Sauce because the product label fails to declare soy, a major food allergen.

    Product
    Kermit's P4 Hot Sauce, 5.5 oz, Key West, FL, UPC 020108012019 & 802468905701
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2016·2015-11-04

    FDA Recalls Custom Surgical Kits Due to Compromised Sterility Assurance

    Resource Optimization & Innovation LLC is recalling 17 custom surgical kits in Texas and Louisiana because a component was recalled for compromised package integrity, potentially affecting sterility.

    Product
    Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0103-2016·2015-11-04

    Kermit's Key Lime Barbecue Sauce Recalled for Undeclared Soy

    Kermit, Inc. is recalling 16 oz bottles of Key Lime Barbecue Sauce due to undeclared soy on the label.

    Product
    Kermit's Sweet & Tasty Key Lime Barbecue Sauce, 16 oz, Key West, FL, UPC 011550150134 & 802468905411
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0163-2016·2015-11-04

    Abbott Recalls ARCHITECT i2000SR Systems Due to Incorrect Tubing

    Abbott Laboratories is recalling 65 ARCHITECT i2000SR diagnostic systems worldwide because they contain incorrect tubing.

    Product
    ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V728000·2015-11-03

    Toyota Recalls 2013-2015 Avalon and Lexus ES for Braking Defect

    Toyota is recalling 2013-2015 Avalon and Lexus ES vehicles because the Pre-Collision System may unexpectedly brake when detecting steel road objects.

    Product
    LEXUS — LEXUS, TOYOTA ES HYBRID, ES350, AVALON HYBRID, AVALON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V726000·2015-11-03

    Forest River Recalls 2016 Recreational Vehicles Due to Shift Cable Defect

    Forest River is recalling 217 model year 2016 recreational vehicles because an incorrect shift cable bracket allows the vehicle to be shifted out of park without applying the brakes.

    Product
    FOREST RIVER — FOREST RIVER, COACHMEN FR3, GEORGETOWN, MIRADA, PURSUIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V724000·2015-11-03

    Diamond Coach Recalls 2006-2011 Buses with Defective Wheelchair Lifts

    Diamond Coach is recalling 49 model year 2006-2011 PT and VIP transit buses equipped with certain Ricon wheelchair lifts. The lifts may have oversized pivot holes that allow bearings to move, potentially causing the platform to fall out of the vehicle.

    Product
    DIAMOND COACH — DIAMOND COACH PT, VIP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16705·2015-11-03

    Carra Imports Recalls Window Shades Due to Strangulation Hazard

    Carra Imports is recalling about 55,500 custom window shades due to a strangulation hazard involving continuous loop cords or exposed inner cords.

    Product
    Window shades
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V720000·2015-11-02

    McNeilus Front Loader Trucks Recalled for Hydraulic Fire Risk

    McNeilus is recalling 2012-2015 front loader trucks because a hydraulic test port tube may crack, allowing fluid to contact hot exhaust components and increase fire risk.

    Product
    MCNEILUS — MCNEILUS ATLANTIC FRONT LOADER, PACIFIC FRONT LOADER, CONTENDER FRONT LOADER, ULTRA FRONT LOADER
    Category
    Vehicle
    Distribution
    Distributed nationwide