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.

12551–12575 of 22165

  • 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-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-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-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 (Devices)·Z-1008-2024·2024-02-14

    Brasseler dental burs recalled due to defective latching mechanism

    Brasseler USA recalls 440 dental burs due to right angle latch specification failure that prevents proper latching in dental handpieces.

    Product
    Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0992-2024·2024-02-14

    RX Series Copper Assay Requires Modified Testing Order

    Randox Laboratories issued a technical bulletin stating that RX Series Copper Assay tests must not be run directly after Total Protein tests, as this could produce falsely elevated copper results.

    Product
    RX Series Copper (Cu) Assay Ref. Number CU2340
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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 (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-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-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-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 (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 (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-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 (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-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-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-0991-2024·2024-02-14

    Flow-e Anesthesia System Model 6887900 Cybersecurity Vulnerability Recall

    The Flow-e Anesthesia System model 6887900 is recalled due to a cybersecurity vulnerability that could allow remote access, denial of service, or code execution, potentially affecting anesthesia delivery safety.

    Product
    Flow-e Anesthesia System, model 6887900
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1016-2024·2024-02-14

    BD antibiotic susceptibility test discs recalled for possible accuracy failures

    BD BBL Sensi Disc Aztreonam test discs are recalled due to possible accuracy and quality control failures in antibiotic susceptibility testing. Failures could result in delayed diagnoses and inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640¿and 231641.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2024·2024-02-14

    BD Sensi Disc Tetracycline Recalls Due to Accuracy and QC Failures

    Becton Dickinson & Co. is recalling BD BBL Sensi Disc Tetracycline 30µg laboratory test kits 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 Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0984-2024·2024-02-14

    Dual Articulating Headrest May Fail to Lock During Surgery

    Steris Corporation is recalling Dual Articulating Headrests that may fail to lock in position during patient procedures, potentially causing patient injury. Affected units were manufactured between August and October 2023.

    Product
    Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
    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-0822-2024·2024-02-14

    Ambriole Moliterno cheese recalled for improper temperature storage

    Greco Sidari is recalling Ambriole Moliterno 7# wheel cheese due to improper temperature storage during distribution. The temperature conditions could allow spoilage and potentially support pathogen growth.

    Product
    AMBRIOLE MOLITERNO 7# WHEEL SUPC/ITEM # 8923
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1029-2024·2024-02-14

    BD BBL Sensi Disc Doripenem antibiotic susceptibility testing accuracy failures

    BD BBL Sensi Disc Doripenem susceptibility testing discs may fail to accurately test antibiotic resistance in H. influenzae, potentially leading to incorrect antibiotic selection and delayed diagnosis. The FDA has recalled 2,363,168 units.

    Product
    BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232219¿
    Category
    Medical Device
    Distribution
    Distributed nationwide