The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

12726–12750 of 27206

  • 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-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 (Devices)·Z-1013-2024·2024-02-14

    BD BBL Sensi Disc Ampicillin testing discs recalled for accuracy failures

    Becton Dickinson is recalling 2.3 million antibiotic susceptibility testing discs due to accuracy and quality control failures. The discs may cause delayed or incorrect test results, potentially leading to inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ¿g, Catalog Number 231660. Used for semi-quantitative in vitro susceptibility testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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-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 (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 (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-0976-2024·2024-02-14

    Orthodontic Latex Elastics Mislabeled as Non-Latex by Manufacturer

    FLEXSelect 5/16" Amber Latex Elastics were labeled as non-latex, creating allergy risk for latex-sensitive patients. Patients with latex allergies should immediately stop using the product.

    Product
    FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0832-2024·2024-02-14

    Galbani Smoked Provalone Recalled for Improper Temperature Storage

    Greco Sidari is recalling 1,375 cases of Galbani Smoked Provalone distributed in Ohio, New York, and Pennsylvania due to improper storage temperatures that could have allowed pathogenic growth.

    Product
    GALBANI SMOKED PROV 3/12# SUPC/ITEM # 19422
    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 (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-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-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-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 (Food)·F-0851-2024·2024-02-14

    Roast Beef Recalled for Improper Temperature Storage and Pathogen Risk

    Greco Sidari is recalling Joey's Roast Beef Sliced Premium because it was not held at appropriate temperatures, potentially allowing pathogenic growth. The product was distributed in Ohio, New York, and Pennsylvania from November 2023 to January 2024.

    Product
    JOEY'S ROAST BEEF SLCD PREMIUM 2/5# SUPC/ITEM # 201172F
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0827-2024·2024-02-14

    Bel Gioioso Cheese Recalled for Improper Storage Temperature

    Bel Gioioso cheese was not held at appropriate temperatures during distribution, potentially allowing spoilage and pathogen growth. Consumers should not consume affected product.

    Product
    BEL GIOIOSO 12/1# EXACT COMBO SUPC/ITEM # 18304
    Category
    Food
    Distribution
    3 states
  • 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-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-1005-2024·2024-02-14

    Medical Device Recall: Guardian 4 Glucose Sensor Manufacturing Defect

    Medtronic is recalling Guardian 4 Glucose Sensors due to manufacturing defects in the glucose oxidase layer. Defects may cause sensors to malfunction or provide inaccurate readings, potentially affecting insulin dosing.

    Product
    Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1031-2024·2024-02-14

    BD BBL Sensi Disc Imipenem susceptibility test accuracy and quality failures

    BD BBL Sensi Disc Imipenem susceptibility test discs may fail to accurately assess antibiotic resistance. This could delay diagnosis or lead to inappropriate antibiotic treatment selection.

    Product
    BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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