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.

10001–10025 of 53042

  • 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-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-0850-2024·2024-02-14

    Ricotta cheese recalled due to improper temperature storage

    Sopra Ricotta Amalfi manufactured by Greco Sidari is recalled because the product was not held at appropriate temperatures. Improper storage could allow spoilage and pathogen growth.

    Product
    SOPRA RICOTTA AMALFI 1/5# SUPC/ITEM # 193650P
    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 (Devices)·Z-1022-2024·2024-02-14

    BD BBL Sensi Disc Ceftaroline test discs recalled for accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Ceftaroline test discs due to potential accuracy and quality control failures in antibiotic susceptibility testing. Incorrect test results may delay diagnosis and lead to inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232231¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0990-2024·2024-02-14

    Flow-c Anesthesia System cybersecurity vulnerability in 14 units

    The Flow-c Anesthesia System model 6887700 has a cybersecurity vulnerability allowing potential denial of service, tampering, or remote code execution via remote login. Fourteen units were distributed in the United States.

    Product
    Flow-c Anesthesia System, model 6887700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0845-2024·2024-02-14

    Marburger Heavy Cream Recalled for Improper Temperature Storage

    Greco Sidari is recalling 1,375 cases of Marburger 40% Heavy Cream due to improper temperature storage that could support pathogen growth. The product was distributed to Ohio, New York, and Pennsylvania between November 26, 2023, and January 5, 2024.

    Product
    MARBURGER 40% HEAVY CREAM 1/32OZ SUPC/ITEM # 039127P
    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 (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 (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-1007-2024·2024-02-14

    Globus Medical Cannula May Not Be Properly Sterilized

    Some ExcelsiusGPS Cannulas have an internal gap that prevents proper sterilization, increasing infection risk. Globus Medical is recalling 570 units distributed worldwide.

    Product
    ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0849-2024·2024-02-14

    Fresh mozzarella cheese recalled for improper temperature storage

    Greco Sidari fresh mozzarella cheese sold in Ohio, New York, and Pennsylvania was not held at appropriate temperatures, which could affect spoilage and potentially support pathogen growth. Consumers should discard affected products or return them to the retailer.

    Product
    GRANDE .33OZ FRESH CILIEGINE MOZZ 1/3# SUPC/ITEM # 19134P
    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-1021-2024·2024-02-14

    BD Sensi Disc Cefpodoxime Antibiotic Testing Discs Recalled for Accuracy Failures

    Becton Dickinson is recalling BD BBL Sensi Disc Cefpodoxime testing discs due to potential accuracy failures in antibiotic susceptibility testing. The defect may cause inaccurate results, delayed diagnosis, or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231673 and 231674¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0993-2024·2024-02-14

    FilmArray Pneumonia Panel Plus Test Kits Recalled for False Positive Results

    BioFire Diagnostics is recalling FilmArray Pneumonia Panel Plus diagnostic test kits due to a potential for false positive results. These inaccurate results could lead to incorrect pneumonia diagnoses.

    Product
    FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0836-2024·2024-02-14

    Galbani Domestic Mascarpone Recalled for Improper Temperature Storage

    Greco Sidari is recalling 1375 cases of Galbani Domestic Mascarpone due to improper storage temperature. The product was not held at appropriate temperatures, which could allow spoilage and support pathogen growth. Affected products were distributed in OH, NY, and PA between November 26, 2023, and January 5, 2024.

    Product
    GALBANI DOMESTIC MASCARPONE 4/5# SUPC/ITEM # 19640
    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-0988-2024·2024-02-14

    Anesthesia System Cybersecurity Vulnerability Poses Denial of Service Risk

    The Flow-i C30 Anesthesia System contains a cybersecurity vulnerability allowing remote attackers to cause denial of service, tampering, or code execution, potentially creating hazardous conditions.

    Product
    Flow-i C30 Anesthesia System, model 6677300
    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 (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-0989-2024·2024-02-14

    Flow-i C40 Anesthesia System Recalled for Cybersecurity Vulnerability

    Getinge's Flow-i C40 Anesthesia System (model 6677400) contains a potential cybersecurity vulnerability allowing remote login attacks that could result in denial of service, system tampering, or remote code execution.

    Product
    Flow-i C40 Anesthesia System, model 6677400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1000-2024·2024-02-14

    Hip Arthroplasty Surgical Instruments Recalled for Sterile Barrier Failure

    Howmedica Osteonics Corp. is recalling hip arthroplasty surgical instruments after their sterile packaging failed integrity testing. Units with compromised packaging were distributed worldwide.

    Product
    HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty
    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 (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