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.

12576–12600 of 22165

  • HighFDA (Devices)·Z-0973-2024·2024-02-14

    Ingenia 1.5T Patient Trolley Wheels May Attract to MRI Magnetic Field

    Philips is recalling Ingenia 1.5T patient transportation trolleys with magnetic wheels that could be attracted to MRI magnetic fields. These wheels pose a potential hazard in MRI-equipped facilities when the trolley operates near the magnetic field.

    Product
    Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1039-2024·2024-02-14

    BD BBL Sensi Disc Antibiotic Test Discs Recalled for Accuracy Failures

    Becton Dickinson is recalling BD BBL Sensi Disc antibiotic susceptibility test discs due to potential accuracy and quality control failures that may lead to incorrect antibiotic selection and delayed diagnosis.

    Product
    BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1012-2024·2024-02-14

    BD antibiotic susceptibility testing discs recalled for accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Ampicillin antibiotic susceptibility testing discs due to accuracy and quality control failures that may cause delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Catalog No. 231263. Used for semi-quantitative in vitro susceptibility testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0829-2024·2024-02-14

    Fresh Mozzarella Cheese Recalled Due to Temperature Control Issues

    Greco Sidari is recalling fresh bocconcini mozzarella cheese distributed across three states because it was not held at appropriate temperatures. Improper storage could lead to spoilage and potentially support pathogen growth.

    Product
    GRANDE 1.5OZ FRESH BOCCONCINI MOZZ 2/3# SUPC/ITEM # 19132
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0840-2024·2024-02-14

    Goat Cheese Recalled Due to Improper Temperature Storage Conditions

    Greco Sidari is recalling Norpaco Sweetie Pepper Goat Cheese (1,375 cases, 1/5# units) distributed in Ohio, New York, and Pennsylvania. The cheese was not held at appropriate temperatures, which could support pathogen growth.

    Product
    NORPACO SWEETIE PEPPER GOAT CHEESE 1/5# SUPC/ITEM # 169956
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0825-2024·2024-02-14

    Resers Red Skin Potato Salad Recall Due to Improper Temperature Storage

    Greco Sidari is recalling Resers Red Skin Potato Salad because it was stored at improper temperatures that could allow pathogen growth. The product was distributed in Ohio, New York, and Pennsylvania.

    Product
    RESERS RED SKIN POTATO SALAD 2/8# SUPC/ITEM # 9139
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1037-2024·2024-02-14

    BD BBL Sensi Disc Piperacillin/Tazobactam Antibiotic Testing Discs Recalled for Accuracy Issues

    BD BBL Sensi Disc Piperacillin/Tazobactam antibiotic susceptibility testing discs are recalled due to potential quality control and accuracy failures. These failures may cause delayed or inaccurate test results, affecting patient diagnosis and antibiotic treatment selection.

    Product
    BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231691 and 231692¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0847-2024·2024-02-14

    Potato salad recalled due to improper temperature control

    Greco Sidari is recalling Resers potato salad due to improper holding temperature during distribution, risking spoilage and pathogen growth. Affected: 1375 cases in Ohio, New York, and Pennsylvania from November 26 to January 5, 2024.

    Product
    RESERS POTATO SALAD REGULAR 1/8# SUPC/ITEM # 0991p
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0981-2024·2024-02-14

    Insulin Assay Reagent Packs Recalled for Incorrect Unit Conversion

    Beckman Coulter is recalling 19,125 Access Ultrasensitive Insulin reagent packs due to an incorrect unit conversion factor in the assay protocol file. The error could produce inaccurate insulin test results.

    Product
    Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1038-2024·2024-02-14

    BD BBL Sensi Disc Rifampin Antibiotic Susceptibility Test Discs Recalled

    BD BBL Sensi Disc Rifampin antibiotic susceptibility test discs are being recalled due to potential accuracy and quality control failures. These discs are distributed domestically nationwide and internationally.

    Product
    BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0846-2024·2024-02-14

    Potato Salad Recalled for Improper Temperature Storage During Distribution

    Resers Potato Salad Regular is being recalled due to improper temperature storage during distribution, which could potentially support pathogen growth. Affected cases were distributed to Ohio, New York, and Pennsylvania from November 2023 to January 2024.

    Product
    RESERS POTATO SALAD REGULAR 3/8# SUPC/ITEM # 0991C
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0861-2024·2024-02-14

    Wegmans Mini Danish Recalled for Undeclared Soy Lecithin

    Wegmans Food Markets recalls 9 oz 10-pack Assorted Mini Danish pastries (UPC 7789050815) because the product contains undeclared soy lecithin, which poses a risk to consumers with soy allergies.

    Product
    9 oz 10pk Assorted Mini Danish, bakery box with clear top (UPC 7789050815)
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0999-2024·2024-02-14

    Surgical hip instruments recalled due to compromised sterility packaging

    Howmedica Osteonics is recalling HRIS ACET CUP surgical instruments used in hip replacement surgery due to failed package seal integrity testing. The recall affects lot-numbered units distributed worldwide.

    Product
    HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0975-2024·2024-02-14

    Patient transportation system wheels may be attracted to MRI magnetic fields

    Ingenia Ambition X patient transportation system trolleys contain magnetic wheels that may be attracted to MRI magnetic fields, potentially causing trolley malfunction during patient procedures.

    Product
    Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0818-2024·2024-02-14

    Reser's Mashed Red Skin Potatoes recalled due to improper temperature storage

    Reser's Mashed Red Skin Potatoes were not held at appropriate temperatures during distribution in Ohio, New York, and Pennsylvania between November 2023 and January 2024. Improper temperature storage could support pathogen growth and spoilage.

    Product
    RESER'S POTATOE POTATOES MASHED RED SKN 4/5# SUPC/ITEM # 3264
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1019-2024·2024-02-14

    BD BBL Sensi Disc Cefixime Antibiotic Susceptibility Test Accuracy Failures

    BD BBL Sensi Disc Cefixime testing discs are recalled due to potential accuracy and quality control failures that may result in delayed diagnosis or inappropriate antibiotic selection in clinical laboratories.

    Product
    BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0842-2024·2024-02-14

    Ricotta Cheese Recalled Due to Improper Temperature Storage

    Grande Ricotta Sopraffina (1375 cases) distributed across Ohio, New York, and Pennsylvania from November 2023 to January 2024 is recalled because it was not held at appropriate temperatures, which could support pathogen growth.

    Product
    GRANDE RICOTTA SOPRAFFINA GRANDE 1/3# SUPC/ITEM # 195351
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0986-2024·2024-02-14

    Absorbable Surgical Tacks Recalled for Potential Sterility Compromise

    Covidien LP is recalling AbsorbaTack Absorbable Fixation Device 30 due to packaging defects that may compromise product sterility. Fifty-four units were distributed in five states.

    Product
    AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures Model ABSTACK30
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0854-2024·2024-02-14

    Seasoned mushroom product recalled due to improper processing procedures

    Ito-Shoten Seasoned Mushroom is recalled due to lack of filed thermal processing procedures. The product was distributed to CA, NJ, IL, TX, and HI.

    Product
    Ito-Shoten Seasoned Mushroom 200g/7.06 oz. Product of Japan Distributed by Mitsuwa Corporation Torrance, CA 90501
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0979-2024·2024-02-14

    Barco MDSC-8527 NXF Medical Display decoder functionality blocked

    Barco is recalling MDSC-8527 NXF medical displays due to I2C cable defects in manufacturing that block the MNA decoder functionality. The recall affects a limited batch distributed in New Jersey.

    Product
    Barco MDSC-8527 NXF, Part Number K9352421
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0820-2024·2024-02-14

    Gorgonzola Cheese Product Recalled for Improper Temperature Storage

    Greco Sidari recalled Norpaco Gorgonzola Stuff Olive cheese cases distributed in Ohio, New York, and Pennsylvania due to improper temperature storage. The temperature failure could have allowed spoilage and potential pathogen growth.

    Product
    Norpaco GORGONZOLA STUFF OLIVE 1/7.5# SUPC/ITEM # 4481
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1017-2024·2024-02-14

    Medical Device Recall: BD BBL Cefaclor Antibiotic Susceptibility Test Disc

    Becton Dickinson is recalling BD BBL Sensi Disc Cefaclor antibiotic susceptibility test discs due to possible accuracy and quality control failures. Affected discs may produce inaccurate results, risking delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231653¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2024·2024-02-14

    Dental amalgam powder may not triturate properly, affecting restoration strength

    Ivoclar Vivadent is recalling dental amalgam powder that may not triturate properly, affecting restoration strength and working characteristics. Dentists should stop using the recalled lot and contact the manufacturer.

    Product
    Article No. NA6050411, Valiant PhD No. 1 Econo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1026-2024·2024-02-14

    Antibiotic Susceptibility Testing Disc Recall Due to Accuracy Concerns

    BD BBL Sensi Disc Chloramphenicol test discs may have accuracy and quality control failures during antibiotic susceptibility testing. This could cause delayed results or inappropriate antibiotic selections.

    Product
    BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733¿and 231274¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0288-2024·2024-02-14

    Omeza Lidocaine Lavage pain relief oil recalled for manufacturing practice violations

    OMEZA LLC has recalled Omeza Lidocaine Lavage pain relief oil (4,390 vials) due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily on January 19, 2024.

    Product
    Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS
    Category
    Drug
    Distribution
    Distributed nationwide