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.

7726–7750 of 52968

  • HighFDA (Food)·F-1640-2024·2024-08-14

    Lunds & Byerlys Caesar Salad Recalled for Undeclared Shellfish and Allergens

    Lunds & Byerlys is recalling Grilled Chicken Caesar Salad that is mislabeled; it is actually Korean Shrimp Salad containing undeclared shellfish, tree nuts (cashew), soybeans, and sesame. Distributed in Minnesota, Lot 301335, Use By 12/04/23.

    Product
    Lunds & Byerlys grilled chicken caesar salad, Net Wt: 9.0 oz. (255.2g) UPC 0 18169-66428 5. Lunds & Byerlys, Edina, MN 55424
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2528-2024·2024-08-14

    Multitom Rax X-Ray Systems Support Arm May Lower Unexpectedly

    The support arm on Siemens Multitom Rax X-ray systems may unintentionally lower, creating a fall risk to people positioned beneath the ceiling-mounted display during system positioning.

    Product
    Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 10860700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2496-2024·2024-08-14

    Automated Medication Dispensing Cabinet Software Issue with Incorrect Bin Labeling

    BD PYXIS MEDBANK automated medication dispensing cabinets with software version 3.9.1.9 may generate incorrect bin location labels during restocking. This could cause medications to be placed in wrong storage locations.

    Product
    BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2507-2024·2024-08-14

    Integra Recalls TruDi NAV Suction Instruments for Calibration Error

    Integra LifeSciences has recalled 265 TruDi NAV Suction Instruments due to incorrect calibration. The miscalibrated units may display inaccurate position information during surgical navigation procedures.

    Product
    TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skull base surgery
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Food)·F-1642-2024·2024-08-14

    Izzio Everything Sourdough Recalled for Potential Plastic Contamination

    Izzio Artisan Bakery is recalling Izzio Everything Sourdough bread due to potential plastic foreign material. The 24oz loaves with specific lot numbers were distributed to retailers and distribution centers in seven states.

    Product
    Izzio Everything Sourdough. Single 24oz loaf packaged into plastic bag. 12 loaves per case.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2501-2024·2024-08-14

    Medication Dispensing Cabinet Software Error Can Print Incorrect Bin Labels

    A software error in CareFusion's BD PYXIS automated medication dispensing cabinet can cause incorrect medication bin numbers to be printed on restock labels, risking medication dispensing errors.

    Product
    BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2533-2024·2024-08-14

    Verigene Gram Positive Blood Culture Test Recalled for Defective Cartridges

    Luminex recalls approximately 1,100 diagnostic kits due to defective test cartridges that may produce false positive results for Staphylococcus lugdunensis and Enterococcus faecium bacteria.

    Product
    Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2483-2024·2024-08-14

    MRI System Software Error Can Overheat Patient Implants

    GE Medical Systems recalled three SIGNA 7.0T MRI systems due to a software error that can exceed preset safety limits during imaging, potentially overheating implants in patients under certain conditions.

    Product
    SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2494-2024·2024-08-14

    Medication Dispensing Cabinet Software Defect Causes Incorrect Bin Labels

    BD PYXIS automated medication dispensing cabinets contain a software issue that may print incorrect bin locations on restock labels. This could result in medications being placed in the wrong bin during restocking.

    Product
    BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2500-2024·2024-08-14

    BD PYXIS MEDBANK Software Issue Causes Incorrect Medication Bin Labels

    A software issue in BD PYXIS MEDBANK automated dispensing cabinets can cause incorrect medication bin labels to print during restocking. This could lead to medication dispensing errors in healthcare facilities.

    Product
    BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2510-2024·2024-08-14

    Philips IntelliVue Patient Monitors lack critical software monitoring options

    Philips IntelliVue Patient Monitors (models MX400/450/500/550) with software versions L.x or M.x are missing three monitoring capability options (MOS, M06, M20) due to software changes, creating potential for delayed or incorrect treatment. The recall involves 18 units distributed nationwide and internationally.

    Product
    IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2476-2024·2024-08-14

    GE SIGNA MR360 MRI System Software Defect May Overheat Implants

    GE SIGNA MR360 MRI systems with software versions SV25.5 or SV25.6 may exceed prescribed RF exposure limits in certain scan configurations, potentially overheating MR-conditional implants. The recall affects 81 units worldwide.

    Product
    SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1648-2024·2024-08-14

    Premo King Club Footlong Sandwiches Recalled for Potential Salmonella Contamination

    Lipari Foods is recalling Premo King Club Footlong sandwiches (UPC 612510094259) due to potential Salmonella contamination. The recall affects 216 cases distributed to retailers across 16 states; consumers should discard the product or return it to the store.

    Product
    Premo King Club Footlong 11.5oz, clear plastic, UPC 612510094259, 4 retail packages per wholesale case
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-2536-2024·2024-08-14

    Steris Hookup Model 2-8-540 Documentation Error Risks Improper Endoscope Disinfection

    Steris Hookup Model 2-8-540 instructions were incorrectly documented, potentially preventing proper endoscope disinfection and risking patient infection.

    Product
    Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2531-2024·2024-08-14

    Pulmonary Heart Valve Grafts Recalled Due to Invalid Test Results

    Artivion is recalling two CryoValve SG heart valve grafts that were approved and implanted with invalid test results.

    Product
    CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2527-2024·2024-08-14

    Medical X-ray display system support arm may lower unexpectedly

    Siemens LUMINOS Lotus Max X-ray displays are being recalled because the support arm may lower unintentionally, potentially injuring people nearby during positioning.

    Product
    LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2503-2024·2024-08-14

    BD PYXIS Automated Dispensing Cabinet Software Issue Causes Incorrect Medication Bin Labels

    A software issue in BD PYXIS automated dispensing cabinets may cause incorrect medication bin labels to print during restocking, potentially leading to medication dispensing errors. CareFusion is recalling 16 units.

    Product
    BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1722-2024·2024-08-14

    Panaderia Guatemex Pegado Bread Recalled for Undeclared Soy Allergen

    Panaderia Guatemex is recalling Pegado bread packaged in plastic bags due to undeclared soy allergen. Affected products were distributed in Georgia, Kentucky, and Tennessee.

    Product
    Panaderia Guatemex - Pegado packaged in plastic bag
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2473-2024·2024-08-14

    MR System Software Defect May Cause Implant Overheating During Scanning

    GE SIGNA Explorer MR imaging systems with affected software versions may overheat implants during certain scan sequences. 2,528 units affected worldwide; no injuries reported.

    Product
    SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2491-2024·2024-08-14

    BD PYXIS MEDBANK Cabinet Software Causes Incorrect Medication Labels

    FDA recall of BD PYXIS MEDBANK automated medication dispensing cabinets due to a software defect that prints incorrect bin information on restock labels, potentially leading to medication identification errors.

    Product
    BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2539-2024·2024-08-14

    Medical Device Hookup Instructions Contain Errors Affecting Endoscope Disinfection

    Steris Corporation recalls certain automated endoscope reprocessor hookups due to incorrect instructions in product documentation. Improper hookup connection could prevent proper endoscope disinfection, risking patient infection.

    Product
    Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated Endoscope Reprocessors ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexib
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2479-2024·2024-08-14

    GE SIGNA Prime MR system can exceed RF safety limits in Low SAR mode

    GE Medical Systems is recalling 72 SIGNA Prime MR imaging systems worldwide. Under specific imaging conditions, the systems can exceed prescribed radiofrequency safety limits, potentially causing MR conditional implants to overheat.

    Product
    SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2497-2024·2024-08-14

    BD PYXIS MEDBANK Medication Cabinet Software Issue Causes Incorrect Bin Labels

    CareFusion is recalling BD PYXIS MEDBANK medication dispensing cabinets due to a software issue that causes incorrect bin information to print on restock labels, potentially leading to medication selection errors.

    Product
    BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2472-2024·2024-08-14

    GE SIGNA Creator MRI systems software defect risks patient implant overheating

    GE HealthCare recalled certain SIGNA Creator MRI systems due to a software defect where the predicted magnetic field strength can exceed prescribed limits in Low SAR Mode with specific imaging sequences, potentially causing overheating of MR-conditional implants.

    Product
    SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1726-2024·2024-08-14

    Panaderia Guatemex Casco bread recalled for undeclared soy allergen

    Panaderia Guatemex is recalling Casco bread due to undeclared soy allergen. The product was distributed in Georgia, Kentucky, and Tennessee.

    Product
    Panaderia Guatemex - Casco packaged in plastic bag
    Category
    Food
    Distribution
    3 states