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.

9976–10000 of 53042

  • 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-0819-2024·2024-02-14

    Garlic-Stuffed Olive Product Recalled Due to Temperature Control Failure

    Greco Sidari is recalling Norpaco garlic-stuffed olives because they were not held at proper temperatures, which could allow spoilage and pathogenic growth. The recall covers 1,375 cases distributed in Ohio, New York, and Pennsylvania.

    Product
    Norpaco GARLIC STUFF OLIVE 1/7.5# SUPC/ITEM # 3461
    Category
    Food
    Distribution
    3 states
  • 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 (Devices)·Z-0862-2024·2024-02-14

    Senographe Pristina X-ray system missing audible exposure termination signal

    GE Medical Systems is recalling 180 Senographe Pristina mammography X-ray systems because the audible signal indicating the end of X-ray exposure intermittently fails to sound, violating FDA safety requirements.

    Product
    Senographe Pristina
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1023-2024·2024-02-14

    BD BBL Antibiotic Susceptibility Test Discs Recalled for Accuracy Failures

    BD BBL Ceftazidime Sensi Discs used for antibiotic susceptibility testing may have accuracy failures affecting H. influenzae testing. This could lead to delayed diagnoses or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632¿and 231633¿
    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 (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 (Food)·F-0855-2024·2024-02-14

    Fresh noodle products recalled for undeclared wheat allergen

    Alfred Louie Inc is recalling Pan Fry and Deep Fry Fresh Noodles due to undeclared wheat allergen from enriched flour sub-ingredients. 550 cases distributed in California are affected.

    Product
    Pan Fry Noodle Fresh Noodles, Alfred Louie, Inc. 24 Lb. cartons, Keep Refrigerated. Deep Fry Noodle Fresh Noodles, Alfred Louie, Inc. 40Lb cartons, Keep Refrigerated.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0974-2024·2024-02-14

    Patient Transportation System Recalled for Magnetic Wheel MRI Interference Risk

    Philips is recalling Ingenia Elition X patient transportation systems due to magnetic wheels that may be attracted to MRI systems, posing a patient safety risk if used in MRI environments.

    Product
    Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
    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-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 (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-0996-2024·2024-02-14

    Globus Medical Cranial Drill recalled for potential sterility compromise

    Globus Medical is recalling Cranial Drills due to potential sterility loss from packaging breaches and discoloration at the drill tip. The drills are used in cranial surgery with the ExcelsiusGPS system.

    Product
    Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0838-2024·2024-02-14

    Bel Gioioso Asiago Cheese Recalled for Temperature Storage Failure

    Bel Gioioso Pepato Asiago cheese was not held at appropriate temperature, which could support pathogen growth. Affected products were distributed in Ohio, New York, and Pennsylvania from November 26, 2023 to January 5, 2024.

    Product
    BEL GIOIOSO PEPATO ASIAGO CON PEPPERCORN 10-8OZ SUPC/ITEM # 53478
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0839-2024·2024-02-14

    Bel Gioioso Provolone Cheese Recalled Due to Improper Storage Temperature

    Greco Sidari is recalling 1,375 cases of Bel Gioioso Provolone Sharp cheese distributed in Ohio, New York, and Pennsylvania. The recall is due to improper storage temperature that could support pathogen growth.

    Product
    BEL GIOIOSO PROVO SHARP 1/25# SUPC/ITEM # 96317
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0843-2024·2024-02-14

    Imported Sharp Provolone Cheese Recalled for Temperature Control Failure

    Greco Sidari is recalling Auricchio imported sharp provolone cheese that was not held at appropriate temperatures, which could promote pathogen growth. The recall affects 1,375 cases distributed to Ohio, New York, and Pennsylvania from November 2023 through January 2024.

    Product
    AURICCHIO IMP SHARP PROV CHEESE 1/17# SUPC/ITEM # 197110
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1033-2024·2024-02-14

    BD BBL Sensi Disc Meropenem testing discs recalled for accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Meropenem antibiotic susceptibility testing discs due to accuracy and quality control failures that may cause delayed or incorrect diagnostic results.

    Product
    BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 and 231704¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0823-2024·2024-02-14

    Locatelli Cheese Product Recalled for Improper Temperature Storage

    Locatelli Crema Di Locatelli cheese was recalled because it was not held at appropriate temperatures. Improper holding temperatures could affect food safety by supporting spoilage and pathogen growth.

    Product
    LOCATELLI CREMA DI LOCATELLI 4/1.1# SUPC/ITEM # 8926
    Category
    Food
    Distribution
    3 states
  • 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 (Food)·F-0828-2024·2024-02-14

    Saputo Stella Cheese Recalled for Improper Temperature Storage

    Saputo Stella cheese distributed in OH, NY, and PA from November 26, 2023 through January 5, 2024 has been recalled due to improper temperature storage. The temperature failure could lead to spoilage and pathogenic growth.

    Product
    SAPUTO STELLA ASGO HLF MLD 11LB SUPC/ITEM # 19009
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0844-2024·2024-02-14

    Mastro Capocollo Cured Meat Recalled for Improper Storage Temperature

    Mastro Capocollo cured meat was not held at proper temperatures, potentially allowing pathogen growth. The recall affects 1,375 cases distributed in Ohio, New York, and Pennsylvania.

    Product
    SOFINA 21202 MASTRO CAPOCOLLC 4 - 6LB SUPC/ITEM # 199694
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0830-2024·2024-02-14

    Fresh Mozzarella Cheese Recalled Over Temperature Storage Risk

    Greco Sidari recalled fresh ciliegine mozzarella sold in Ohio, New York, and Pennsylvania due to improper temperature storage that could allow spoilage and potential pathogen growth.

    Product
    GRANDE .33OZ FRESH CILIEGINE MOZZ 2/3# SUPC/ITEM # 19134
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1032-2024·2024-02-14

    BD BBL Sensi Disc Levofloxacin Testing Discs Recalled for Accuracy Failures

    Becton Dickinson is recalling 2,363,168 units of BD BBL Sensi Disc Levofloxacin testing discs (Catalog No. 231705, 231706) due to potential accuracy and quality control failures in antibiotic susceptibility testing that could lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 and 231706¿
    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