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.

13301–13325 of 53086

  • HighFDA (Devices)·Z-1575-2023·2023-05-17

    STA R Max Analyzer Firmware Bug Produces Inaccurate Coagulation Test Results

    Diagnostica Stago is recalling the STA R Max fully automatic clinical analyzer due to a firmware bug that causes intermittent shortened coagulation times and increased technical errors, potentially producing inaccurate blood clotting test results.

    Product
    STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1572-2023·2023-05-17

    APLS IgM Diagnostic Reagent Packs Recalled Due to Incorrect Conjugate

    Bio-Rad Laboratories is recalling 932 BioPlex 2200 APLS IgM Reagent Packs (Lot 301538) nationwide because they were packaged with incorrect conjugate. This could result in false-positive and false-negative test results.

    Product
    BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0853-2023·2023-05-17

    Chocolate Covered Oreos recalled for undeclared soy, milk, and tree nut allergens

    Windy Hill Chocolate LLC is recalling Chocolate Covered Oreos due to undeclared soy, milk, and tree nut allergens. The product was distributed domestically and poses a risk to consumers with allergies to these ingredients.

    Product
    Chocolate Covered Oreos
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1578-2023·2023-05-17

    Sheath Introducer Kit with Incorrect Needle Size Recalled

    Merit Medical Systems is recalling COBRA-OS Sheath Introducer Kits due to an incorrect needle size that may affect proper insertion during medical procedures.

    Product
    COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0860-2023·2023-05-17

    Ajikal Age Ichiban Snack Recalled for Undeclared Coconut Allergen

    Ajikal Age Ichiban 97g snacks are being recalled due to undeclared coconut, a tree nut allergen that can cause allergic reactions. The affected product was distributed across multiple US states and Canada.

    Product
    Ajikal Age Ichiban 97g UPC: 4510656600906
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1579-2023·2023-05-17

    BD Pyxis MedStation ES software failure causes patient data loss

    BD Pyxis automated dispensing cabinet software versions 1.7.0 through 1.7.4 experience download failures causing partial loss of patient information and transaction data. This may result in dispensing incorrect medication doses, allergenic medications, or discontinued medications.

    Product
    BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0874-2023·2023-05-17

    Kajitani Food Congeri Crispy recalled due to undeclared coconut allergen

    Kajitani Food Congeri Crispy crackers (104g, UPC 4901332108661) contain coconut but do not list it in the ingredients or allergen statement. Consumers with coconut allergies may be at risk; approximately 2,199 units were distributed to retail locations across multiple US states and Canada.

    Product
    Kajitani Food Congeri Crispy 104g UPC: 4901332108661
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0849-2023·2023-05-17

    Hazelnut Crunch Recalled for Undeclared Allergens: Soy, Milk, Tree Nuts

    Windy Hill Chocolate LLC is recalling Hazelnut Crunch (batch #1119220112) due to undeclared allergens: soy, milk, and tree nuts. Consumers with allergies to these ingredients should not consume the product.

    Product
    Hazelnut Crunch
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1576-2023·2023-05-17

    STA Compact Analyzer Firmware Bug Causes Inaccurate Test Results

    Diagnostica Stago is recalling STA Compact Analyzers due to a firmware bug causing intermittent shortened coagulation times and increased technical errors. No illnesses or injuries have been reported.

    Product
    STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0873-2023·2023-05-17

    Kanro Non-Sugar Tea House Recalled for Undeclared Coconut Allergen

    Kanro Non-Sugar Tea House 40g has been recalled because coconut allergen is not listed in the product ingredients. Consumers with coconut allergies should not consume this product.

    Product
    Kanro Non-Sugar Tea House 40g UPC: 4901351013144
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1574-2023·2023-05-17

    Medtronic Spinal Distractor Rack Recalled for Manufacturing Defect

    Medtronic is recalling Distractor Rack devices used in spinal surgery due to manufacturing defects that may prevent proper device operation. Two lot numbers are affected and were distributed to facilities in Indiana, Connecticut, and Nebraska.

    Product
    Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1484-2023·2023-05-17

    ANGIOGUARD RX/XP Emboli Capture Guidewire System Separation Risk

    Cordis has recalled 684 units of ANGIOGUARD RX/XP Emboli Capture Guidewire System due to potential separation of the delivery system and capture sheath during use, which could cause stroke or require unplanned surgical intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0872-2023·2023-05-17

    Mini Pound Cake Recalled for Undeclared Coconut Allergen

    Saint Lavian mini pound cake chocolate is being recalled because coconut is not listed on the ingredients label. Consumers with coconut allergies are at risk.

    Product
    Saint Lavian mini pound cake chocolate 2 pieces UPC: 4973341408841
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0882-2023·2023-05-17

    Smoked Wahoo Dip Recalled Due to Undeclared Yellow #5 Allergen

    Borris Brothers is recalling Smoked Wahoo Dip due to undeclared Yellow #5 (tartrazine), an allergen that may affect consumers with sensitivity. The recall affects 112 containers distributed in Florida.

    Product
    Smoked Wahoo Dip, Net Wt. 8oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0875-2023·2023-05-17

    Kajitani Food Cigar Fry Recalled for Unlabeled Coconut

    Kajitani food cigar fry (110g, UPC 4901332108289) contains coconut that is not declared on the label. The undeclared allergen poses a health risk to consumers with coconut allergies.

    Product
    Kajitani food cigar fry 110g UPC: 4901332108289
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0861-2023·2023-05-17

    Ajikal Kotsubukko Snack Recalled for Undeclared Coconut

    Ajikal 44g Kotsubukko snacks containing undeclared coconut were distributed across multiple US states and Canada. Consumers with a coconut allergy should not consume this product.

    Product
    Ajikal 44g Kotsubukko 4 series UPC: 4510656600708
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1569-2023·2023-05-17

    Aesculap Caiman Articulating Surgical Device Recalled for Loose Spring

    Aesculap Caiman Articulating electrosurgical devices are being recalled because a spring may become loose and fall out during surgery, potentially entering the patient's body.

    Product
    Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery. Product Code: PL771SU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0880-2023·2023-05-17

    Fujiya Country Ma'am Snacks Recalled for Undisclosed Peanut Allergen

    Daiso California Warehouse is recalling Fujiya Country Ma'am Vanilla & Cocoa wafers because they contain peanut (sheanut) that is not declared on the label. Consumers with peanut allergies should not consume this product.

    Product
    Fujiya Country Ma'am Vanilla & Cocoa 19 sheets UPC: 4902555272641
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0857-2023·2023-05-17

    Raspberry Products Recalled for Undeclared Soy, Milk, and Tree Nut Allergens

    Windy Hill Chocolate LLC is recalling raspberry products due to undeclared soy, milk, and tree nut allergens. Products with batch number 0120230121 and expiration date 4/12/23 may contain these allergens not listed on packaging.

    Product
    Raspberry
    Category
    Food
    Distribution
    0 states