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.

12526–12550 of 22165

  • 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 (Food)·F-0848-2024·2024-02-14

    Fresh mozzarella cheese recalled due to improper temperature storage

    Greco Sidari is recalling GRANDE fresh bocconcini mozzarella because the product was not held at appropriate temperatures during storage. The temperature failure could allow spoilage and pathogen growth.

    Product
    GRANDE 1.5OZ FRESH BOCCONCINI MOZZ 1/3# SUPC/ITEM # 19132P
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0826-2024·2024-02-14

    Bellissimo Mascarpone cheese recalled due to improper temperature storage

    Greco Sidari is recalling Bellissimo Mascarpone (1375 cases) distributed to OH, NY, and PA due to improper temperature storage that could allow spoilage and pathogenic growth.

    Product
    BELLISSIMO MASCARPONE SUPC/ITEM # 18270
    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 (Devices)·Z-0987-2024·2024-02-14

    Flow-i C20 Anesthesia System cybersecurity vulnerability could enable remote attacks

    The Flow-i C20 Anesthesia System has a cybersecurity vulnerability allowing potential remote access, denial of service attacks, or code execution. Healthcare facilities should contact the manufacturer for patches and guidance.

    Product
    Flow-i C20 Anesthesia System, model 6677200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0982-2024·2024-02-14

    Laboratory Analyzer Software Bug Could Produce Erroneous Clinical Test Results

    Beckman Coulter DxI 9000 immunoassay analyzers may produce erroneous lab results due to software bugs affecting unit conversion and result calculation. Affected devices use software version 1.16 or earlier; 128 devices worldwide are impacted.

    Product
    DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2024·2024-02-14

    RotaFlow Centrifugal Pump sterile barrier defect FDA Class II recall

    RotaFlow Centrifugal Pumps have potential seal defects that could compromise sterile barriers, risking infection in cardiac bypass patients. FDA recommends device identification and contact with manufacturer for remediation.

    Product
    BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
    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-0852-2024·2024-02-14

    Conway Caesar Classic Dressing recall: improper temperature storage

    Greco Sidari is recalling Conway Caesar Classic Dressing in 4-gallon cases due to improper temperature storage that could support pathogen growth. No illnesses have been reported. The recall affects 1,375 cases distributed to Ohio, New York, and Pennsylvania.

    Product
    CONWAY CAESAR CLASSIC DRESSING 4/1GAL SUPC/ITEM # 38119D1
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1020-2024·2024-02-14

    Cefotaxime antibiotic susceptibility test discs recalled for potential testing accuracy failures

    BD BBL Sensi Disc Cefotaxime susceptibility testing discs may produce inaccurate results for H. influenzae, potentially leading to delayed diagnosis and inappropriate antibiotic selection. The FDA has recalled 2,363,168 units distributed domestically and internationally.

    Product
    BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607¿; 5 ug, Catalog No. 291308¿
    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 (Devices)·Z-1027-2024·2024-02-14

    BD antibiotic susceptibility test disc accuracy failures may affect H. influenzae diagnosis

    Becton Dickinson is recalling antibiotic susceptibility test discs due to quality control failures that may produce inaccurate results. These failures could delay diagnosis and lead to inappropriate antibiotic selection for H. influenzae infections.

    Product
    BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657¿and 231658¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Food)·F-0864-2024·2024-02-14

    Wegmans Chocolate and Almond Ready-to-Bake Croissants Recalled for Undeclared Soy

    Wegmans Food Markets is recalling its Ready To Bake Chocolate and Almond Variety Pk croissants due to undeclared soy lecithin. The product may pose a risk to consumers with soy allergies.

    Product
    Ready To Bake Chocolate and Almond Variety Pk (UPC 87-85300-05013-0)
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-1035-2024·2024-02-14

    BD BBL Moxifloxacin Test Discs Recalled for Susceptibility Testing Inaccuracy

    BD BBL Sensi Disc Moxifloxacin test discs are recalled due to possible failures in antibiotic susceptibility testing accuracy. Test failures could lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1024-2024·2024-02-14

    BD BBL Sensi Disc Ceftriaxone Test Discs Recalled for Susceptibility Testing Accuracy Issues

    BD BBL Sensi Disc Ceftriaxone susceptibility test discs may have accuracy and quality control failures. These defects could lead to delayed diagnosis or incorrect antibiotic selection for H. influenzae infections.

    Product
    BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231634 and 231635¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1011-2024·2024-02-14

    Lab testing discs recalled for potential antibiotic susceptibility testing failures

    Becton Dickinson recalled 2.3 million lab testing discs used for antibiotic susceptibility testing due to potential quality control failures. These failures could lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-quantitative in vitro susceptibility testing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1030-2024·2024-02-14

    BD BBL Ertapenem Susceptibility Test Discs Recalled for Accuracy Failures

    BD BBL Sensi Disc Ertapenem test discs are being recalled due to reproducibility and accuracy failures that may cause diagnostic errors, delayed diagnosis, or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 and 232175¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0977-2024·2024-02-14

    RotaFlow Centrifugal Pump Seal Defect Poses Infection Risk

    Maquet Medical Systems is recalling 1,090 RotaFlow centrifugal pumps used in heart surgery due to seal defects that could compromise sterile barriers and expose patients to infection.

    Product
    BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1036-2024·2024-02-14

    BD BBL Sensi Disc Ofloxacin discs recalled for antibiotic testing accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Ofloxacin testing discs due to potential accuracy failures. These failures could lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0833-2024·2024-02-14

    Ricotta cheese recalled for improper temperature control

    Greco Sidari's ricotta cheese was not held at appropriate temperatures, which could affect food spoilage and potentially support pathogen growth. The recall affects 1375 cases distributed in OH, NY, and PA.

    Product
    GRANDE RICOTTA SOPRAFFINA 6/3# SUPC/ITEM # 19535
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0997-2024·2024-02-14

    Globus Medical Cranial Drill recalled for sterility breach risk

    Globus Medical is recalling Cranial Drill 6.00mm units due to potential packaging breaches that may render the sterile product non-sterile, and discoloration near the drill tip.

    Product
    Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1015-2024·2024-02-14

    Antibiotic susceptibility test discs recalled for accuracy and quality failures

    Becton Dickinson is recalling BD BBL Sensi Disc Azithromycin test discs due to potential accuracy and quality control failures that may delay diagnosis or result in inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-quantitative in vitro susceptibility testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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