The Recall Desk

Archive

August 2024 recalls

595 recalls were announced in August 2024.

What the numbers show

Critical
16
Severe
134
High
374
Moderate
69
Low
2

Of the 595 recalls this month scored against our rubric, 3% are Critical, 23% are Severe.

Which agencies issued them

301–400 of 595

  • HighFDA (Devices)·Z-2475-2024·2024-08-14

    GE SIGNA MR355 MRI System Recalled for Potential Implant Overheating Risk

    GE SIGNA MR355 MRI systems running software versions SV25.5 or SV25.6 may cause implant overheating in certain scanning conditions. Risk occurs when using specific imaging sequences with the Optimized T2 FLAIR feature disabled.

    Product
    SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2466-2024·2024-08-14

    SIGNA PET/MR diagnostic imaging system poses implant overheating risk

    GE HealthCare recalled SIGNA PET/MR systems with specific software versions due to a configuration issue that can cause RF energy to exceed safety limits, potentially overheating MR-conditional implants.

    Product
    SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonance
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2467-2024·2024-08-14

    Discovery MR450 MRI System Can Overheat Implants Under Specific Conditions

    GE Discovery MR450 MRI systems with certain software versions can cause implant overheating under specific scanning conditions. 23 units worldwide require firmware updates.

    Product
    Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2462-2024·2024-08-14

    GE SIGNA Premier MRI system software overheating risk to implants

    GE Medical Systems is recalling 404 SIGNA Premier MRI systems worldwide due to a software issue where radiofrequency energy can exceed prescribed safety limits during specific imaging sequences, potentially overheating MR-conditional implants.

    Product
    SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2513-2024·2024-08-14

    Surgical Staple Reinforcement Devices Recalled for Incorrect Expiration Dating

    W.L. Gore & Associates recalled 51 units of GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement due to incorrect expiration date labeling. The devices were labeled with a four-year and ten-day expiration date instead of the validated two-year shelf life.

    Product
    GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2490-2024·2024-08-14

    BD PYXIS automated medication cabinet software defect causes incorrect bin labels

    A software defect in BD PYXIS MEDBANK automated medication dispensing cabinets may cause the incorrect medication bin to be printed on restock labels, potentially resulting in medication errors.

    Product
    BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2532-2024·2024-08-14

    FDA Recalls CryoPatch Cardiac Tissue Grafts Due to Invalid Test Results

    Artivion has recalled CryoPatch SG cardiac tissue patches used in pulmonary surgeries due to approval and release with invalid test results. Patients who received implants should consult their healthcare provider.

    Product
    (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2515-2024·2024-08-14

    Centurion Procedure Kits with Defective Syringes Recalled Worldwide

    Medline Industries is recalling Centurion procedure kits due to defective plastic syringes affected by an FDA safety alert. The syringes may leak or break and pose a potential risk to patient health.

    Product
    Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2474-2024·2024-08-14

    SIGNA MR380 MRI system software may exceed implant heating limits

    GE SIGNA MR380 MRI systems with software versions SV25.5 or SV25.6 may exceed radiofrequency heating limits during certain imaging sequences, potentially causing MR-conditional implants to overheat. The issue occurs in Low SAR Mode when specific T2 FLAIR sequences are used with the Optimized T2 FLAIR option disabled.

    Product
    SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2514-2024·2024-08-14

    Diagnostic Test Kits Recalled for False Vibrio Results With Certain Transport Medium

    BioFire Diagnostics is recalling gastrointestinal diagnostic test kits due to false positive Vibrio results when used with certain transport mediums.

    Product
    BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnost
    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-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-2523-2024·2024-08-14

    Biopsy Drape Pack sterilization failure recall from American Contract Systems

    American Contract Systems is recalling 224 Biopsy Drape Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised the sterility of affected units. Lot 981241 distributed in CA, KS, ME, MN, MO, NE, and SD is affected.

    Product
    American Contract Systems Biopsy Drape Pack convenience kit
    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-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 (Devices)·Z-2509-2024·2024-08-14

    Philips IntelliVue Patient Monitors with disabled monitoring software options

    Philips IntelliVue Patient Monitors (MX400/450/500/550) with software versions L.x or M.x lack required monitoring capabilities due to removed software entitlements. The missing features could lead to incorrect or delayed patient treatment.

    Product
    IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2511-2024·2024-08-14

    Philips IntelliVue Patient Monitors Shipped with Missing Monitoring Capabilities

    Philips IntelliVue patient monitors shipped or updated with software that removes monitoring capabilities, potentially delaying or resulting in incorrect treatment.

    Product
    IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. 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-2461-2024·2024-08-14

    MRI System Software Miscalculation May Overheat Patient Implants

    A software error in GE SIGNA Hero MRI systems can cause overheating of MR conditional implants under specific conditions. The recall affects 95 units distributed worldwide.

    Product
    SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2471-2024·2024-08-14

    GE SIGNA 1.5T MR Systems May Overheat Implants in Low SAR Mode

    GE Medical Systems recalled 2,146 SIGNA 1.5T MR systems that may overheat implants during certain imaging sequences in Low SAR mode due to a software defect in radiofrequency safety calculations.

    Product
    1.5T SIGNA HDxt Family, 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 (Devices)·Z-2486-2024·2024-08-14

    Automated dispensing cabinet software issue causes incorrect medication bin labels

    CareFusion is recalling 232 automated medication dispensing cabinets due to a software issue that may print incorrect medication bin labels, potentially causing medication dispensing errors.

    Product
    BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2498-2024·2024-08-14

    Automated Dispensing Cabinet Software Error May Print Incorrect Medication Bin Labels

    CareFusion's BD PYXIS MEDBANK automated dispensing cabinet contains a software flaw that may print incorrect medication bin labels, potentially leading to dispensing of wrong medications.

    Product
    BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2520-2024·2024-08-14

    Medical Procedure Kit Recalled Over Potential Sterilization Compromise

    American Contract Systems is recalling Special Procedure Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised sterility. Distributed in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.

    Product
    American Contract Systems Special Procedure Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2460-2024·2024-08-14

    GE SIGNA Pioneer MR Systems May Overheat Patient Implants During Scanning

    GE SIGNA Pioneer MR systems with certain software versions may allow radiofrequency exposure to exceed prescribed limits in Low SAR Mode when using specific imaging sequences, potentially causing overheating of MR conditional implants.

    Product
    SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0 to PX28.4, PX29.0, PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·24V610000·2024-08-14

    Holiday Rambler Admiral motorhomes recalled for missing GFCI outlet protection

    Certain 2019-2025 Holiday Rambler Admiral and other RVs have exterior patio outlets lacking GFCI protection when powered by generator or shore cord, increasing electrical shock risk. Dealers will install GFCI devices free of charge.

    Product
    FLEETWOOD — FLEETWOOD, HOLIDAY RAMBLER FLAIR, ADMIRAL, ECLIPSE, FLEX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2488-2024·2024-08-14

    BD PYXIS Automated Medication Cabinet Software Label Error Affects 11 Units

    CareFusion's BD PYXIS medication dispensing cabinet with software version 3.9.1.9 may print incorrect bin labels during restocking, potentially leading to wrong medication dispensing. Eleven units distributed nationwide are affected.

    Product
    BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-2477-2024·2024-08-14

    GE Brivo MR355 MRI System Software Issue Causing Implant Overheating Risk

    GE HealthCare has recalled certain Brivo MR355 MRI systems due to a software issue that can cause overheating of implanted medical devices in specific imaging scenarios. Approximately 375 units have been affected worldwide.

    Product
    Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 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-2542-2024·2024-08-14

    Olympus Everest Bipolar Cutting Forceps Recalled for Packaging Defects

    Olympus is recalling Everest Bipolar Cutting Forceps due to fractures and breakages in packaging trays and Tyvek covers that may compromise sterility. The recall affects 4,364 units distributed worldwide.

    Product
    The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2481-2024·2024-08-14

    SIGNA UHP MRI System Software Versions May Cause Implant Overheating

    GE Medical Systems is recalling SIGNA UHP MRI systems with software versions RX28.0 or MR30.1. A configuration issue can cause radiofrequency output to exceed prescribed limits, potentially overheating MR conditional implants.

    Product
    SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use only
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2484-2024·2024-08-14

    SIGNA MAGNUS MRI Software Can Overheat Implanted Devices

    GE Medical Systems recalled SIGNA MAGNUS MRI systems with software versions MR29.1 or RX29.1. Under specific imaging conditions in Low SAR Mode, the system may exceed safe radiofrequency power limits and cause implanted medical devices to overheat.

    Product
    SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance Imaging System - research use only
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2469-2024·2024-08-14

    GE SIGNA Artist MR system may overheat implants in certain sequences

    GE Medical Systems is recalling SIGNA Artist MR imaging systems because they may produce radiofrequency power exceeding user-set limits when using certain imaging sequences in Low SAR Mode, potentially causing MR-conditional implants to overheat.

    Product
    SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-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-2540-2024·2024-08-14

    Olympus Everest Bipolar Cutting Forceps Recalled for Packaging Defects

    Olympus is recalling Everest Bipolar Cutting Forceps surgical instruments due to fractures and breakages in packaging trays and Tyvek covers that may compromise sterility. Affected batches: FR150448, FR154445, FR173022.

    Product
    The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2512-2024·2024-08-14

    Baxter Precision Surgical Table Recall: Loose Spring Pins Risk

    Baxter Healthcare Corporation is recalling the PST 500 U Precision Surgical Table due to loose spring pins that can cause the tabletop to unexpectedly tilt or move, potentially causing unintended patient movement during surgery.

    Product
    Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
    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-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 (Devices)·Z-2529-2024·2024-08-14

    Paraffin Embedding Station Recalled for Internal Fire and Toxic Smoke Risk

    The FDA is recalling 180 Leica HistoCore Arcadia H paraffin embedding stations due to a sealing defect in the paraffin tank that can cause toxic smoke and internal fire.

    Product
    Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2537-2024·2024-08-14

    Medical Device Hookup Instructions Incorrect, Risking Endoscope Disinfection

    Steris Corporation recalls 129 Hookup devices (Model 2-8-540HAN) due to incorrect hookup instructions in product documentation. Using wrong connections may prevent proper endoscope disinfection, creating infection risk.

    Product
    Hookup Model/Catalog Number: 2-8-540HAN 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 dispens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1721-2024·2024-08-14

    Panaderia Guatemex Champurradas Recalled for Undeclared Soy

    Panaderia Guatemex is recalling Champurradas due to the presence of undeclared soy allergen. The recall affects 170 bags distributed in Georgia, Kentucky, and Tennessee.

    Product
    Panaderia Guatemex - Champurradas packaged in plastic bag
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2530-2024·2024-08-14

    Baxter SIGMA Spectrum Infusion Pump recall due to inadequate pre-release testing

    Baxter Healthcare is recalling the SIGMA Spectrum Infusion Pump (Serial 2158913) distributed nationwide in Florida. The recall is due to improperly performed testing procedures prior to release, which may affect device function.

    Product
    Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1674-2024·2024-08-14

    Nuts.com Ground Sumac Products Recalled for Undeclared Gluten

    Nuts.com is recalling Ground Sumac products due to undeclared gluten. Products were distributed online to consumers in multiple U.S. states, Canada, and the U.S. Virgin Islands.

    Product
    Nuts.com Ground Sumac 1 lb resealable stand-up pouches and 20 lb double lined plastic bags in a cardboard box.
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-2492-2024·2024-08-14

    Automated Medication Cabinet Software Bug May Print Wrong Bin Labels

    CareFusion's BD PYXIS MEDBANK medication dispensing cabinets (software 3.9.1.9) have a software defect that may cause restock labels to print incorrect medication bin locations, creating a risk of medication dispensing errors.

    Product
    BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.9.1.9
    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-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-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 (Devices)·Z-2489-2024·2024-08-14

    BD PYXIS MEDBANK Automated Cabinet May Print Incorrect Medication Bin Labels

    A software issue in the BD PYXIS MEDBANK automated medication dispensing cabinet can cause incorrect bin labels to be printed for restock operations. This could lead to medication administration errors affecting patient safety.

    Product
    BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 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-2482-2024·2024-08-14

    MRI System Software Error Can Cause Implant Overheating in Low SAR Mode

    GE HealthCare's Discovery MR950 MRI system may incorrectly calculate heating safety limits when using certain imaging sequences in Low SAR Mode, potentially causing overheating of MR-conditional implants.

    Product
    Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2478-2024·2024-08-14

    GE Optima MR360 MRI System Software May Overheat Implants

    GE Optima MR360 MRI systems with affected software versions may exceed safe radiofrequency energy limits, potentially overheating MR-conditional implants when specific imaging sequences are used. 469 units are affected worldwide.

    Product
    Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1725-2024·2024-08-14

    Concha Mexicana Pastries Recalled Due to Undeclared Soy Allergen

    Panaderia Guatemex is recalling Concha Mexicana pastries due to undeclared soy allergen. Consumers with soy allergies should not consume this product.

    Product
    Panaderia Guatemex - Concha Mexicana packaged in plastic bag
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1727-2024·2024-08-14

    Panaderia Guatemex Roscas Recalled for Undeclared Soy Allergen

    Panaderia Guatemex is recalling 170 bags of Roscas due to undeclared soy allergen. The product was distributed in Georgia, Kentucky, and Tennessee.

    Product
    Panaderia Guatemex - Roscas packaged in plastic bag
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2464-2024·2024-08-14

    GE Discovery MR750 MRI System Software May Cause Implant Overheating

    GE HealthCare is recalling certain MR750 MRI systems with specific software versions. When using particular imaging sequences in Low SAR Mode without the Optimized T2 FLAIR option, the radiofrequency field can exceed safe limits, risking overheating of MR-conditional implants.

    Product
    Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2470-2024·2024-08-14

    GE SIGNA Voyager MRI systems risk implant overheating under specific configurations

    GE SIGNA Voyager MRI systems may exceed prescribed radiofrequency limits under specific operating conditions, risking overheating of MR conditional implants. The issue occurs with certain imaging sequences when the Optimized T2 FLAIR option is disabled.

    Product
    SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1643-2024·2024-08-14

    Izzio Everything Rolls recalled for potential plastic contamination

    Izzio Artisan Bakery is recalling Izzio Everything Rolls due to potential plastic contamination. Affected lot numbers are 24183C and 24183A.

    Product
    Izzio Everything Roll packaged in 12oz plastic bag, 6 rolls per bag - 16 bags per case.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1650-2024·2024-08-14

    Premo Turkey & Swiss 6oz Deli Meat Recalled for Potential Salmonella

    Lipari Foods is recalling Premo Turkey & Swiss 6oz deli meat packages due to potential Salmonella contamination. No illnesses have been reported.

    Product
    Premo Turkey & Swiss 6oz, clear plastic, UPC 612510001042, 4 retail packages per wholesale case
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-2502-2024·2024-08-14

    Automated Dispensing Cabinet Software Issue Causing Incorrect Medication Bin Labels

    A software defect in the BD PYXIS MEDBANK automated dispensing cabinet causes incorrect medication bin locations to be printed on restock labels, potentially resulting in medication dispensing errors. No illnesses or injuries have been reported.

    Product
    BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 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 (Devices)·Z-2468-2024·2024-08-14

    GE MR450w 1.5T MRI software defect may cause implant overheating

    GE MR450w 1.5T MRI systems may overheat MR-conditional implants when using specific imaging sequences with Low SAR Mode. No injuries reported; 1,607 units affected worldwide.

    Product
    Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1641-2024·2024-08-14

    Black Forge Kitchen Knives Recalled for Elevated Lead Levels

    Black Forge Knives is recalling multiple kitchen knife models distributed in Georgia and via Bespoke Post due to elevated lead levels in the blades.

    Product
    1- Name: Carbon Steel Utility Kitchen Knife Model: CSK1700 Size: Total length: 10.25" Type of packaging: Each knife packed in a single box 2- Name: Carbon Steel Utility Kitchen Cleaver Knife Model: CSK1701 Size: Total length: 10.5" Type of pac
    Category
    Consumer Product
    Distribution
    1 state
  • 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-2534-2024·2024-08-14

    Philips Azurion X-ray System: Potential Loss of Imaging Functionality

    The Philips Azurion Interventional Fluoroscopic X-ray System may lose imaging functionality or experience longer restart times. The FDA is recalling approximately 3,011 units of this device worldwide.

    Product
    Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, car
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1664-2024·2024-08-14

    Palmer Patriotic White Fudge Cookies Recalled for Potential Salmonella

    Palmer & Company is recalling Palmer Patriotic White Fudge Cookies in 7oz and 13.5oz sizes due to potential salmonella contamination. Affected products were distributed nationwide in the United States and Canada.

    Product
    1. Palmer Patriotic White Fudge Cookies, Net Wt. 7oz, UPC 7723237084, 16/7oz case 2. Palmer Patriotic White Fudge Cookies, Net Wt. 13.5 oz, UPC 7723237085, 8/13.5oz case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2463-2024·2024-08-14

    GE SIGNA HDxt 3.0T MRI systems may overheat implanted devices

    GE Medical Systems is recalling 3.0T SIGNA HDxt MRI systems because radiofrequency energy can exceed safety limits under specific operating conditions, potentially overheating implanted medical devices in patients.

    Product
    3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16.0_V03, HD23.0_V03; 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-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-2508-2024·2024-08-14

    Philips IntelliVue Patient Monitor Software Missing Critical Entitlements

    Philips IntelliVue Patient Monitor models with software L.x and M.x lack critical monitoring capabilities due to a software update. This could result in incorrect or delayed patient treatment.

    Product
    IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. 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 (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-2526-2024·2024-08-14

    Luminos dRF Max X-ray Display Support Arm May Unintentionally Lower

    Siemens recalled 24 units of the Luminos dRF Max X-ray display system because the support arm may unintentionally lower, potentially injuring personnel positioned beneath the equipment.

    Product
    Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V609000·2024-08-14

    2023 CFMOTO Ibex 800 Motorcycles: Throttle Wire Failure Risk

    CFMOTO is recalling certain 2023 Ibex 800 S and Ibex 800 T motorcycles because the throttle wire may break, causing loss of throttle control and engine stall, which increases crash risk.

    Product
    CFMOTO — CFMOTO IBEX800-S, IBEX800-T
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2499-2024·2024-08-14

    Automated Medication Dispenser Software Bug Causes Incorrect Bin Labels

    BD PYXIS MEDBANK automated medication dispensers may print incorrect medication bin labels due to a software defect, risking medication handling errors in healthcare settings.

    Product
    BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2519-2024·2024-08-14

    American Contract Systems surgical kits recalled for sterilization defect

    American Contract Systems Laparoscopy and Lap Chole surgical kits are being recalled because insufficient aeration time after sterilization may have compromised their sterility. The kits were distributed in seven U.S. states.

    Product
    American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1644-2024·2024-08-14

    Aldi Mixed Sourdough Loaf Recalled for Potential Plastic Contamination

    Izzio Artisan Bakery is recalling 9500 cases of Aldi Mixed Sourdough loaves due to potential plastic contamination. The affected products were distributed across seven states: Illinois, Michigan, Texas, Ohio, New Jersey, Florida, and Arizona.

    Product
    Aldi Mixed Sourdough loaf. A single 24oz loaf packaged into plastic bag, 12 loaves per case.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1719-2024·2024-08-14

    Panaderia Guatemex Sheca Anis Bread Recalled for Undeclared Soy Allergen

    Panaderia Guatemex is recalling Sheca Anis bread products due to undeclared soy allergen. The recall affects 170 bags distributed in Georgia, Kentucky, and Tennessee.

    Product
    Panaderia Guatemex - Sheca Anis packaged in plastic bag
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2517-2024·2024-08-14

    American Contract Systems Hand Pack Convenience Kit Sterilization Failure

    American Contract Systems is recalling Hand Pack convenience kits that may not be sterile due to insufficient aeration time during sterilization. Affected devices distributed in CA, KS, ME, MN, MO, NE, and SD may pose a safety risk.

    Product
    American Contract Systems Hand Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1669-2024·2024-08-14

    Favorite Day Bakery White Fudge Mini Cookies recalled for salmonella

    Favorite Day Bakery White Fudge Mini Cookies (7oz) recalled nationwide in the US and Canada due to potential salmonella contamination.

    Product
    Favorite Day Bakery White Fudge Mini Cookies, Net Wt 7oz, UPC 85239 92319, 16/7oz case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2525-2024·2024-08-14

    Siemens x-ray display system support arm may lower unexpectedly

    Siemens Luminos Agile Max x-ray imaging systems have a support arm that may unintentionally lower during display positioning, creating an injury risk.

    Product
    Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2485-2024·2024-08-14

    Automated medication cabinet software prints incorrect bin labels

    The BD PYXIS MEDBANK MINI automated dispensing cabinet software may print incorrect bin locations on restock labels, potentially causing medications to be placed in wrong locations.

    Product
    BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2521-2024·2024-08-14

    Surgical Convenience Kits Recalled for Potential Sterilization Failure

    American Contract Systems is recalling three surgical convenience kits due to potential sterilization failure from insufficient aeration time during processing.

    Product
    American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1657-2024·2024-08-14

    Palmer Patriotic Snack Mix Recalled for Potential Salmonella Contamination

    Palmer & Company is recalling Palmer Patriotic Snack Mix (13 oz, Best By 1/19/25–2/1/25) due to potential Salmonella contamination. The product was distributed nationwide in the United States and Canada.

    Product
    Palmer Patriotic Snack Mix, A Seasonal Mix of Sweet & Salty Favorites, Net Wt. 13 oz., UPC 77232 37061, 12/13oz case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1723-2024·2024-08-14

    Panaderia Guatemex Curenitos Recalled for Undeclared Soy Allergen

    Panaderia Guatemex is recalling 170 bags of Curenitos due to undeclared soy allergen. Consumers with soy allergies should not consume this product.

    Product
    Panaderia Guatemex - Curenitos packaged in plastic bag
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1720-2024·2024-08-14

    Panaderia Guatemex Churros Recalled Due to Undeclared Soy Allergen

    Panaderia Guatemex is recalling churros with undeclared soy allergen distributed in GA, KY, and TN. Consumers with soy allergies should not consume this product.

    Product
    Panaderia Guatemex - Churros packaged in plastic bag
    Category
    Food
    Distribution
    3 states
  • 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 (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-2459-2024·2024-08-14

    SIGNA Architect MRI System Software Can Exceed Implant Heating Limits

    GE Medical Systems is recalling SIGNA Architect MRI systems in which software may allow B1+ radiofrequency exposure to exceed user-prescribed limits during certain T2 FLAIR imaging sequences, risking MR-conditional implant overheating.

    Product
    SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1638-2024·2024-08-14

    Brown Sugar Simple Syrup Recalled for Potential Under-Processing

    Urban River Spirits is recalling Brown Sugar Simple Syrup due to manufacture in an unlicensed, uninspected facility with potential under-processing concerns.

    Product
    Brown Sugar Simple Syrup is a non-alcoholic cocktail mixer. Product is packaged in glass 5oz. bottle and sold under brand Urban River Spirits.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Drugs)·D-0628-2024·2024-08-14

    PEG-3350 Oral Solution Recalled for Defective Non-Sealed Pouches

    A PEG-3350 oral solution is being recalled nationwide due to defective pouches that may not be properly sealed, risking product leakage. The recall affects 13,200 cartons with lot number S300542.

    Product
    PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID — PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID (PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1615-2024·2024-08-14

    Urban River Spirits Raspberry Lemon Mixer recalled for potential under-processing

    Urban River Spirits is recalling Raspberry Lemon Mixer because the product was manufactured in an unlicensed and uninspected facility. The recall concerns potential under-processing issues.

    Product
    Raspberry Lemon Mixer is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-1632-2024·2024-08-14

    Non-Alcoholic Cocktail Mixer Recalled for Potential Under-Processing Risk

    Urban River Spirits is recalling Summer Sunset Strawberry and Peach non-alcoholic cocktail mixer from multiple states because it was manufactured in an unlicensed and uninspected facility, creating potential under-processing concerns.

    Product
    Summer Sunset Strawberry and Peach is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-1620-2024·2024-08-14

    Non-alcoholic cocktail mixer made in unlicensed facility recalled

    Urban River Spirits is recalling its Lemon Drop Mixer due to being manufactured in an unlicensed, uninspected facility with potential under-processing concerns affecting product safety. The product was distributed across multiple states.

    Product
    Lemon Drop Mixer is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-1629-2024·2024-08-14

    Non-Alcoholic Cocktail Mixer Recalled Due to Unlicensed Facility Production

    Urban River Spirits recalls Sunkissed Lavender and Lemon non-alcoholic cocktail mixer (750ml glass bottles) manufactured in an unlicensed, uninspected facility due to potential under-processing concerns.

    Product
    Sunkissed Lavender and Lemon is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-1623-2024·2024-08-14

    Keep It Spicy cocktail mixer recalled for potential under-processing

    Urban River Spirits recalled Keep It Spicy Pear & Jalapeno Mixer because it was produced in an unlicensed, uninspected facility with potential under-processing. The product was distributed across 11 states.

    Product
    Keep It Spicy Pear & Jalapeno Mixer is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-1631-2024·2024-08-14

    Urban River Spirits Cocktail Mixer Recalled for Under-Processing Risk

    Urban River Spirits is recalling Tropical Lime & Coconut non-alcoholic mixer because it was manufactured in an unlicensed facility with potential under-processing. No illnesses have been reported.

    Product
    Tropical Lime & Coconut is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-1630-2024·2024-08-14

    Urban River Spirits Velvet Cocoa and Caramel Mixer Recalled for Potential Under-Processing

    Urban River Spirits voluntarily recalls Velvet Cocoa and Caramel cocktail mixer due to potential under-processing from manufacture in an unlicensed, uninspected facility. Product distributed across 11 states.

    Product
    Velvet Cocoa and Caramel is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-1616-2024·2024-08-14

    Life s a Peach Spritzer Recalled for Unlicensed Facility and Under-Processing

    Urban River Spirits Life s a Peach Spritzer is recalled because it was manufactured in an unlicensed, uninspected facility with potential under-processing. No illnesses have been reported.

    Product
    Life s a Peach Spritzer is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    11 states

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