The Recall Desk

Archive

October 2024 recalls

601 recalls were announced in October 2024.

What the numbers show

Critical
4
Severe
86
High
449
Moderate
62

Of the 601 recalls this month scored against our rubric, 1% are Critical, 14% are Severe.

301–400 of 601

  • HighNHTSA·24V783000·2024-10-18

    Rimac Nevera Recalled for Potential Electrical Cable Fire Risk

    Rimac is recalling 2023-2024 Nevera vehicles because a low-voltage cable may not be secured properly, posing a fire risk. Owners are advised not to drive until inspected.

    Product
    RIMAC — RIMAC NEVERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V778000·2024-10-18

    2024 Ford Maverick Child Seat Tether Anchor Defect Recall

    Ford is recalling 2024 Maverick vehicles because the second-row child seat tether anchors may not properly secure a child seat due to incomplete thread engagement, increasing injury risk in a crash.

    Product
    FORD — FORD MAVERICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·25015·2024-10-17

    Colsen Fire Pits Recalled for Burn Injury Risk from Flame Jetting

    Colsen-branded tabletop fire pits are being recalled due to the risk of invisible alcohol flames causing flame jetting and fire spreading. The hazard can cause serious burns in less than one second.

    Product
    Colsen-branded fire pits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·25011·2024-10-17

    Anker Power Banks Recalled for Fire and Burn Hazards

    Anker power banks with model numbers A1642, A1647, and A1652 have been recalled because the lithium-ion battery can overheat and catch fire, causing burn injuries. The firm has received 28 reports of overheating and fires, with two burn injuries reported.

    Product
    Anker Power Banks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25701·2024-10-17

    Arctic Cat and Tracker Off-Road Vehicles Recalled for Crash Hazard

    Textron Specialized Vehicles is recalling about 7,000 model year 2022–2024 Arctic Cat Prowler Pro and Tracker Off Road 800SX side-by-side vehicles because they can move while the digital dash displays "park," creating a rollaway crash hazard.

    Product
    Model Years 2022-2024 Arctic Cat Prowler Pro / Pro Crew and Tracker Off Road 800SX / 800SX Crew Side by Side Recreational Off Highway Vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V772000·2024-10-17

    2025 BMW X3 front passenger air bag may not deploy properly

    BMW is recalling certain 2025 X3 xDrive30i and X3 M50i vehicles because the front passenger air bag fabric may have been damaged during transport. A damaged air bag may not inflate properly, increasing injury risk in a crash.

    Product
    BMW — BMW X3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25012·2024-10-17

    Oliva Cigars Recalls Slim Lighters Missing Child-Safety Feature

    About 60,000 promotional cigar slim lighters branded Nub, Serie V, Cain, and Oliva lack child-resistant mechanisms and pose fire and burn hazards to young children under age 5.

    Product
    Nub, Serie V, Cain, and Oliva branded Promotional Cigar Slim Lighters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24E088000·2024-10-17

    LiveWire Recalls Two Up Seat Kits Due to Grab Strap Defect

    LiveWire is recalling Two Up Seat Kits for Mulholland motorcycles because the passenger grab strap may detach, increasing crash risk.

    Product
    SEATS:MOTORCYCLE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0005-2025·2024-10-16

    Z-800 Infusion System Recalled for Air-in-Line Software Algorithm Defect

    Zyno Medical LLC is recalling the Z-800 Infusion System due to a defect in the air-in-line software algorithm. Approximately 34,994 units distributed nationwide are affected by this Class I FDA recall.

    Product
    Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V770000·2024-10-16

    2025 Ford Bronco suspension defect may cause loss of steering control

    Ford is recalling 2024-2025 Bronco and 2024 Ranger vehicles because the front upper control arm ball joint fastener may not be properly tightened or installed, potentially causing loss of steering control.

    Product
    FORD — FORD RANGER, BRONCO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0023-2025·2024-10-16

    7-Eleven Fudge Brownies Recalled Due to Undeclared Walnuts

    Innovation Bakers has recalled 7-Eleven Fudge Brownies with Chocolate Chip due to undeclared walnuts. The product was distributed to Southern California 7-Eleven stores and may cause allergic reactions in consumers with walnut allergies.

    Product
    7-Eleven Fudge Brownie with Chocolate Chip, 3.5 oz. UPC: 05254856392
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0008-2025·2024-10-16

    Vail-Bon Jie Yang Wan capsules recalled for undeclared pharmaceutical ingredients

    Vail-Bon Jie Yang Wan capsules have been recalled for containing undeclared dexamethasone and chlorpheniramine. The product was marketed without FDA approval.

    Product
    Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0039-2025·2024-10-16

    GE Healthcare Centricity Universal Viewer may fail to display latest diagnostic report

    GE Healthcare Centricity Universal Viewer Zero Footprint Client version 6.0 SP11.x may fail to show the latest diagnostic report by default when a study contains multiple DICOM structured reports in different series.

    Product
    GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129; c)¿¿¿¿¿ 2089507-131; d)¿¿¿¿ 2089507-135; e)¿¿¿¿ 2089507-136; f)¿¿¿¿¿¿ 2089507-140; g)¿¿¿¿¿ 2089507-144; h)¿¿¿¿ 2089507-145; i)¿
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·24V768000·2024-10-16

    Multiquip Recalls Trailers Due to Frame Weld Cracking Risk

    Multiquip is recalling specific 2010-2016 trailers because frame welds may crack or break, reducing stability and increasing crash risk.

    Product
    MULTIQUIP — MULTIQUIP TRLR-57615, TRLR-55164, TRLR-55348
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0025-2025·2024-10-16

    Coca-Cola recalls Minute Maid Zero Sugar Lemonade due to mislabeling

    COCA COLA Consolidated LLC recalls Minute Maid Zero Sugar Lemonade cartons sold in Indiana, Kentucky, and Ohio. Regular Minute Maid Lemonade cans were incorrectly placed in Zero Sugar packaging.

    Product
    Minute Maid Zero Sugar Lemonade 12 cans carton UPC 0 25000 12115 9 CANNED UNDER THE AUTHORITY OF THE COCA-COLA COMPANY, ATLANTA, GA
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0054-2025·2024-10-16

    MEDIHONEY Dressing Applicator Pouch Recalled for Sterility Concerns

    Integra LifeSciences recalls MEDIHONEY Dressing applicator pouches due to potential pinholes that may compromise sterility. The recall affects approximately 120,124 units distributed across 36 US states and internationally.

    Product
    MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0022-2025·2024-10-16

    FastPack TSH Calibrator Kit Recalled Due to Incorrect Barcode

    Qualigen Inc is recalling the FastPack TSH Calibrator Kit due to an incorrect barcode linked to incorrect information. The barcode defect may allow successful system calibration, but TSH test results obtained could be higher than expected.

    Product
    FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0020-2025·2024-10-16

    Philips IntelliVue Patient Monitor Software Configuration Disables Enhanced ECG Alarms

    Philips patient monitors with Option CP2 software version P.01.01 were factory-configured incorrectly, leaving enhanced arrhythmia detection alarms disabled. Affected devices will not trigger yellow alarms for enhanced arrhythmia detection.

    Product
    IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indica
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0042-2025·2024-10-16

    Respiratory Pathogen Panel Recalled Due to False Positive Results

    The NxTAG Respiratory Pathogen Panel is recalled due to false positive results for human metapneumovirus in about 7.6% of samples, especially those positive for other respiratory pathogens.

    Product
    NxTAG Respiratory Pathogen Panel, REF: I051C0447
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0034-2025·2024-10-16

    MEDLINE Digital Blood Pressure Monitor Recalled Due to Microchip Faults

    MEDLINE is recalling 7,428 Automatic Digital Blood Pressure Monitors due to a faulty microchip causing power-on failures, display issues, and overheating. Units were distributed in the US, Panama, and Jamaica.

    Product
    MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2025·2024-10-16

    Medical Analyzer Software Flaw Allows Use of Expired Calibrator

    Beckman Coulter DxI 9000 immunoassay analyzers with software version 1.16.2 and prior can process orders using expired calibration material, potentially producing incorrect patient laboratory test results.

    Product
    Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0037-2025·2024-10-16

    FDA Recalls EPIONE Device Due to Internal Component Corrosion

    Quantum Surgical recalls 2 units of the EPIONE device v1.0.2 because rust has developed on the central axis component of the Needle Guide product. These units were distributed in Florida.

    Product
    The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. Du
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0026-2025·2024-10-16

    BD Synapsys Laboratory Software May Display Incorrect Antibiotic Susceptibility Results

    BD Synapsys Informatics Solution versions 4.20–5.30 contain a software error that may incorrectly display antibiotic susceptibility results, potentially leading to inadequate or prolonged antibiotic treatment.

    Product
    BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0021-2025·2024-10-16

    Trevo Trak 21 Microcatheter Distributed with Incorrect Instructions and Labels

    Stryker Neurovascular is recalling Trevo Trak 21 Microcatheters because Out-of-US approved instructions and labels were distributed instead of US-approved versions. Affected customers in CA and VA should contact the manufacturer.

    Product
    The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiop
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0055-2025·2024-10-16

    Enterprise Imaging XERO Viewer medical software reference line placement error

    Enterprise Imaging XERO Viewer incorrectly displays reference lines on medical images due to a software defect affecting images with non-square pixel spacing. The misplaced reference lines may lead to diagnostic errors.

    Product
    Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2025·2024-10-16

    Knee Replacement Implant Recalled for Out-of-Spec Locking Tabs

    The FDA is recalling the Triathlon Universal TS Baseplate Size 2 knee implant due to defective locking tabs that may not properly engage with the tibial insert, potentially causing implant failure.

    Product
    Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0045-2025·2024-10-16

    Check-Flo Performer Introducer Set white caps may disconnect

    Cook Incorporated is recalling Check-Flo Performer Introducer Sets due to white caps that may disconnect from the shaft-hub connection. Affected units were distributed to Australia.

    Product
    Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0050-2025·2024-10-16

    StealthStation S8 Spine Surgery Navigation System Recalled for Software Defects

    Medtronic is recalling 1,801 StealthStation S8 surgical navigation systems due to software anomalies that can flip navigation images during spine surgery and prevent warning messages for suboptimal imaging settings.

    Product
    StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0035-2025·2024-10-16

    Philips Patient Information Center iX Network Connectivity Issue Affects Settings Synchronization

    Philips Patient Information Center iX devices may fail to synchronize settings when network DHCP leases expire during offline operation, causing the devices to receive new IP addresses that are not recognized after reconnection.

    Product
    Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0053-2025·2024-10-16

    Medline Sterile Laparoscopy Pack Recalled for Component Defect

    Medline recalls Sterile Laparoscopy Packs due to a manufacturing defect in the Detachable Endo Pocket component. The tube may stretch from the pouch during surgical procedures, potentially affecting tissue collection.

    Product
    Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0027-2025·2024-10-16

    Tonsil tray kits recalled for containing component under improper use recall

    Windstone Medical Packaging recalls 642 kits of Aligned Medical Tonsil Trays because they contain Cardinal Health Salem Sump PVC tubes that are subject to a separate recall for improper use.

    Product
    Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0051-2025·2024-10-16

    Endoscopy and Bronchoscopy Systems Power Cord Defect Risk

    Monarch Platform endoscopy and bronchoscopy systems may have defective power cords causing electrical shorts and shock risk if exposed wires are touched, potentially leading to system shutdown.

    Product
    Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0043-2025·2024-10-16

    Medical Device Recall: Respiratory Panel May Report Incorrect hMPV Results

    The NxTAG Respiratory Pathogen Panel may produce false positive results for human Metapneumovirus (hMPV), potentially leading to incorrect co-infection diagnoses.

    Product
    NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0038-2025·2024-10-16

    3M Tegaderm CHG I.V. Dressing Recalled for Foreign Contamination

    3M is recalling Tegaderm CHG I.V. Securement Dressing (REF 1658R) due to contamination with foreign substance matter. The affected lot (33WWRRR) was distributed to South Korea.

    Product
    3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0033-2025·2024-10-16

    Medline Blood Pressure Monitor Recalled for Microchip Failure and Overheating

    Medline is recalling approximately 9,608 automatic digital blood pressure units due to a faulty microchip that causes power failures, display issues, and overheating.

    Product
    MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0052-2025·2024-10-16

    Monarch Platform Urology Device Recalled for Power Cord Electrical Hazard

    Auris Health is recalling Monarch Platform (Urology) devices due to strain relief defects in power cords that may cause electrical short and potential shock to operating room staff.

    Product
    Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0040-2025·2024-10-16

    Inspire Respiratory Sensing Lead Model 4340 Serial Number Label Mismatch

    FDA recall of 152 Inspire Model 4340 Respiratory Sensing Lead units due to a labeling error—the serial number printed on the product box does not match the actual serial number of the device inside.

    Product
    Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0030-2025·2024-10-16

    Aligned Medical T and A Pack Recalled for Component Misuse Risk

    Windstone Medical Packaging is recalling Aligned Medical T and A Pack REF AMS11482 because it contains a component subject to a separate recall action for improper use.

    Product
    Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0024-2025·2024-10-16

    Gelato Ice Cream Recalled for Possible Container Fragmentation

    ALCAS USA CORP. is recalling gelato ice cream packaged in compostable tubs due to possible fragmentation of the container material. Affected products were distributed in the USA, Cayman Islands, and Canada.

    Product
    Gelato ice cream packaged in Compostable Tubs which are labeled in part Vaschetta Accoppiata Compostabile . The gelato is packaged in four (4) sizes of Compostable Tubs: COMPOSTABLE YETI TUB 350 GR/ 500 CC (M) (16.90 fl. oz.) COMPOSTABLE YETI TUB 500 Gr/750 CC (25.36 fl. oz.)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0041-2025·2024-10-16

    Inspire Model 4063 Stimulation Lead Labeling Error — Serial Number Mismatch

    Inspire Medical Systems is recalling 457 Model 4063 Stimulation Leads because the serial number on the shelf box does not match the serial number of the device inside, creating identification and traceability issues.

    Product
    Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0024-2025·2024-10-16

    iCast Covered Stent Recalled for Unique Device Identifier Labeling Error

    Atrium Medical Corporation is recalling 11 iCast Covered Stents (Model 42616) due to an error in the Unique Device Identifier (UDI) printed on the distribution label. No illnesses or injuries have been reported.

    Product
    iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0029-2025·2024-10-16

    Aligned Medical Septo Pack recalled for containing component under FDA recall

    The Aligned Medical Septo Pack (AMS11480) is recalled because it contains a Cardinal Health Salem Sump PVC tube component that is subject to an FDA recall for improper use.

    Product
    Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0031-2025·2024-10-16

    Aligned Medical Tonsil Packs Recalled Due to Improper-Use Kit Component

    Windstone Medical Packaging is recalling Aligned Medical Tonsil Pack kits due to a component under recall for improper use. Approximately 180 packs were distributed nationwide.

    Product
    Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0028-2025·2024-10-16

    Aligned Medical Tonsil ENT Pack Recalled for Component Under Separate Recall

    Windstone Medical is recalling 894 Aligned Medical Tonsil ENT Packs containing Cardinal Health Salem Sump PVC tubes due to improper use concerns with a component under a separate recall action.

    Product
    Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0044-2025·2024-10-16

    MAKO Integrated Cutting System Handpiece Recalled for Characterization Process Error

    Howmedica Osteonics Corp. is recalling 897 MAKO Integrated Cutting System (MICS) Handpieces worldwide due to a manufacturing characterization process error that resulted in incorrect constant values being assigned to affected units.

    Product
    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V765000·2024-10-15

    Lamborghini Recalls 2024 Revuelto Vehicles Due to Wiper Rod Defect

    Lamborghini is recalling 2024 Revuelto vehicles because a wiper connecting rod may bend and separate, causing wiper failure and reduced visibility.

    Product
    LAMBORGHINI — LAMBORGHINI REVUELTO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V764000·2024-10-15

    2018–2022 BMW X3 rear cargo rail attachment defect recall

    BMW is recalling 2018–2022 X3 vehicles because rear cargo rail attachment bolts may become damaged in a rear crash, causing the rail to detach and increasing injury risk. Dealers will replace the bolts free of charge.

    Product
    BMW — BMW X3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V767000·2024-10-15

    2024 Toyota Sequoia Hybrid and Tundra Tire Sidewall Damage Recall

    Certain 2024 Toyota Sequoia Hybrid, Tundra, and Tundra Hybrid vehicles are recalled due to passenger-side front and rear tire sidewall damage that may cause sudden tire pressure loss and loss of vehicle control.

    Product
    TOYOTA — TOYOTA TUNDRA, TUNDRA HYBRID, SEQUOIA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·24V766000·2024-10-15

    McNeilus Recalls Rear Loaders Due to License Plate Light Defect

    McNeilus is recalling 2010-2024 Rear Loader vehicles because the license plate light is installed in the wrong location, potentially failing to fully illuminate the plate.

    Product
    MCNEILUS — MCNEILUS REAR LOADER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V763000·2024-10-14

    2025 Honda Civic fuel pump defect poses fire risk

    Honda is recalling certain 2023-2025 model year Civic vehicles because the high-pressure fuel pump may crack and leak fuel, increasing the risk of fire if an ignition source is present. Owners should contact Honda for free inspection and replacement.

    Product
    HONDA — HONDA ACCORD, CIVIC, CIVIC HYBRID, CR-V HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V762000·2024-10-14

    Entegra Ethos and Jayco Swift Incorrect Tire Load Label Recall

    Jayco is recalling 2,044 units of 2021–2025 Entegra Ethos and Jayco Swift vehicles due to an incorrect Tire and Loading Information Label. The mislabeled tire load range could lead owners to select underrated replacement tires, increasing crash risk.

    Product
    JAYCO — JAYCO, ENTEGRA SWIFT LI, SWIFT, ETHOS LI, ETHOS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V758000·2024-10-11

    Blue Bird Recalls School Buses for Illegible Emergency Exit Labels

    Blue Bird is recalling 2019-2024 Vision and All American school buses because emergency exit labels are too small to read, potentially delaying evacuation.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN, VISION, VISION SCHOOL BUS, ALL AMERICAN SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V761000·2024-10-11

    Hyundai Nexo Hydrogen Pressure Relief Device Defect Creates Fire Risk

    Hyundai is recalling 2019-2024 Nexo vehicles because the hydrogen pressure relief device may fail and leak, creating a fire risk. Owners are advised to park outside until the repair is complete.

    Product
    HYUNDAI — HYUNDAI NEXO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V759000·2024-10-11

    Blue Bird Transit Bus Recall for Illegible Emergency Exit Labels

    Blue Bird is recalling 2020-2024 All American and 2021-2024 Vision transit buses because emergency exit labels are too small to read, potentially delaying evacuation.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN TRANSIT BUS, VISION TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V760000·2024-10-11

    E-One Recalls Fire Trucks Due to Engine Crossmember Defect

    E-One is recalling 282 fire trucks because a broken engine crossmember can damage the cooling fan, causing an engine stall and increasing crash risk.

    Product
    E-ONE — E-ONE TYPHOON N, CYCLONE N, QUEST II, CYCLONE II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·25009·2024-10-10

    Fisher-Price Recalls 2.1 Million Snuga Infant Swings for Suffocation Risk

    Fisher-Price is recalling approximately 2.1 million Snuga Infant Swings due to suffocation hazard when the product is used for sleep or bedding is added. Five deaths have been reported between 2012 and 2022.

    Product
    All Models of Fisher-Price Snuga Swings
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·24E085000·2024-10-10

    Land Rover Recalls AJ20-P6 Engines for Oil Filter Housing Cracks

    Land Rover is recalling AJ20-P6 replacement engines because the oil filter housing may crack and leak, increasing the risk of fire or road hazards.

    Product
    ENGINE AND ENGINE COOLING:ENGINE:OIL/LUBRICATION recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V756000·2024-10-10

    GM Recalls 2018-2019 Trucks for Air Bag Inflator Defect

    General Motors is recalling specific 2018-2019 Chevrolet and GMC trucks because side air bag inflators may rupture, posing an injury risk.

    Product
    GMC — GMC, CHEVROLET SIERRA 3500, SIERRA 2500, SILVERADO 3500, SILVERADO 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24E084000·2024-10-10

    Jaguar Recalls AJ20-P6 Engines Due to Oil Filter Housing Leak Risk

    Jaguar is recalling certain AJ20-P6 replacement engines because the oil filter housing may crack and leak, posing a fire and crash risk.

    Product
    ENGINE AND ENGINE COOLING:ENGINE:OIL/LUBRICATION recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V755000·2024-10-10

    2024 GMC Sierra EV front turn signals may be difficult to see

    General Motors is recalling certain 2024 GMC Sierra EV vehicles. The front turn signal lights are too similar in brightness to the parking lights, making them difficult to see and increasing crash risk.

    Product
    GMC — GMC SIERRA EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24E083000·2024-10-10

    Chrysler Recalls MOPAR Trailer Tow Mirrors Due to Detaching Glass

    Chrysler is recalling specific MOPAR trailer tow mirrors because the glass may detach, reducing driver visibility and increasing crash risk.

    Product
    VISIBILITY:REARVIEW MIRRORS/DEVICES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V754000·2024-10-10

    2020-2023 RAM 1500 Heated Rearview Mirror Glass May Detach

    Chrysler is recalling 2020-2023 RAM 1500 vehicles with heated trailer tow rearview mirrors. The mirror glass may detach, reducing driver visibility and increasing crash risk.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25010·2024-10-10

    NPW Group Recalls Halloween Projector Flashlights Due to Fire and Burn Hazards

    NPW Group is recalling about 4,700 Halloween Projector Flashlights sold at Target in September 2024 because they can overheat, melt, and cause fire and burn injuries. Consumers should stop using them immediately and return them to Target for a refund.

    Product
    Halloween Projector Flashlights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25006·2024-10-10

    Droyd Fury Youth All-Terrain Vehicles Recalled for Laceration Hazard

    Droyd Fury Youth ATVs fail to comply with federal ATV safety regulations. The handlebars pose a laceration hazard if struck at high speed, risking serious injury or death.

    Product
    Droyd Fury Youth All-Terrain Vehicles (ATVs)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25008·2024-10-10

    Gimars Playpens Recalled for Head Entrapment and Suffocation Hazards

    About 6,200 Gimars Playpens with Mat are recalled because the basketball hoop accessory poses a head entrapment hazard and children can become entrapped beneath the mattress, creating a suffocation risk. The products violate federal play-yard safety regulations.

    Product
    Gimars Playpen with Mat
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25005·2024-10-10

    Allen + Roth Lighted Bathroom Mirrors Recalled for Glass Detachment Hazard

    Homewerks Worldwide is recalling about 3,300 Allen + Roth-branded lighted bathroom mirrors sold at Lowe's because the glass can detach from the wall base and fall, creating injury and laceration risks. No injuries have been reported.

    Product
    Allen + Roth-branded Lighted Bathroom Mirrors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25007·2024-10-10

    Droyd Multi-Purpose Helmets Recalled for Head Injury Risk

    Reyhee Group is recalling about 400 Droyd multi-purpose helmets sold online from October 2023 through July 2024. The helmets do not meet federal safety requirements and can fail to protect wearers in a crash.

    Product
    Droyd multi-purpose helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V757000·2024-10-10

    2024-2025 Kia EV9 Instrument Panel Display Software Error Recall

    Kia is recalling 2024-2025 EV9 vehicles due to a software error affecting the instrument panel display. The display may fail to show critical safety information such as the speedometer and warning lights.

    Product
    KIA — KIA EV9
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1838-2024·2024-10-09

    Kandy brand whole cantaloupes recalled for possible Salmonella contamination

    Eagle Produce LLC is recalling Kandy brand whole cantaloupes due to possible Salmonella contamination. The recalled product (224 cases of 9-count boxes) was distributed to Michigan, Missouri, Ohio, Texas, and Virginia.

    Product
    Whole cantaloupe, brand name Kandy, packed in a corrugated box, 9 count
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·24V752000·2024-10-09

    Brake Pedal May Collapse on 2025 Dodge Hornet and Related Vehicles

    Chrysler is recalling 2024-2025 Dodge Hornet and Alfa Romeo Tonale vehicles because the brake pedal may collapse, causing loss of brake function and increasing crash risk. Dealers will reinforce the brake pedal arm at no cost.

    Product
    DODGE — DODGE, ALFA ROMEO HORNET, TONALE PHEV, TONALE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3208-2024·2024-10-09

    Percussionaire IPV Therapy In-Line Valve Recalled for Labeling Deficiency

    Percussionaire Corporation recalled 2523 IPV therapy in-line valves due to insufficient labeling regarding cap removal prior to use. Updated labeling ensures patients and healthcare providers understand proper device preparation.

    Product
    Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0004-2025·2024-10-09

    Gold Hard Steel Plus Liquid recalled for undeclared acetaminophen and sildenafil

    FDA has recalled Gold Hard Steel Plus Liquid because the product was marketed without FDA approval and contains undeclared pharmaceutical ingredients: acetaminophen and sildenafil.

    Product
    Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0003-2025·2024-10-09

    Hard Steel Capsules Recalled for Undeclared Acetaminophen and Sildenafil

    Hard Steel Capsules contain undeclared acetaminophen and sildenafil and were marketed without FDA approval. All 729 units distributed nationwide and internationally are included in the recall.

    Product
    Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0005-2025·2024-10-09

    FDA Recalls Veklury Injection Vials for Presence of Glass Particles

    Gilead Sciences recalls 105,000 vials of Veklury (remdesivir) for injection nationwide because glass particles are present in the medication.

    Product
    VEKLURY — VEKLURY (REMDESIVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0003-2025·2024-10-09

    MiniMed Insulin Pumps May Stop Delivering Insulin After Physical Impact

    Medtronic MiniMed insulin pumps (670G, 770G, 780G) that have been dropped or bumped may develop internal battery defects causing premature failure and interrupted insulin delivery, risking dangerously high blood sugar.

    Product
    MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762; MiniMed 770G, REF: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 780G, REF: MMT-1884, MM
    Category
    Medical Device
    Distribution
    53 states
  • SevereFDA (Food)·F-0016-2025·2024-10-09

    Raisin Bran Muffins Recalled for Undeclared Milk and Wheat Allergens

    The Posh Bakery, Inc. is recalling Whole Grains Bakery Raisin Bran Muffins (6 oz) due to undeclared whey (milk) and wheat allergens and missing allergen labeling.

    Product
    Whole Grains Bakery labeled "Raisin Bran Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090 UPC "7 13583 05 104 7"
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3207-2024·2024-10-09

    Percussionaire IPV In-Line Valve Recall: Blue Cap Removal Labeling Update

    Percussionaire is recalling the P5-TEE IPV in-line valve to update labeling and ensure the blue cap is removed before use and delivery of the device.

    Product
    Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0004-2025·2024-10-09

    Neo-Tee T-Piece Resuscitator circuit flow controller may come apart

    Mercury Medical is recalling approximately 1,300 Neo-Tee T-Piece Resuscitators due to a manufacturing defect that may cause the circuit flow controller to come apart, potentially compromising emergency respiratory support.

    Product
    Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Food)·F-1837-2024·2024-10-09

    Chicken and Duck Eggs Recalled for Potential Salmonella Contamination

    Milo's Poultry Farms is recalling chicken and duck eggs sold in foodservice and consumer packages in Illinois, Michigan, and Wisconsin due to potential Salmonella contamination.

    Product
    Grade A Brown Chicken Eggs, in shell, Bulk 15 dozen. For Foodservice. Keep Refrigerated. Sold with the following brands: 1. Milo's Poultry Farms, N 3873 Valley Road, Bonduel, WI 54107. Organic Eggs from Free Range Hens. 2. M&E Family Farms, Eggs from Free Range Hens. N
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0001-2025·2024-10-09

    MiniMed Insulin Pumps Recalled for Battery Depletion and Delivery Risk

    Medtronic MiniMed 630G and 700G insulin pumps may experience battery depletion and device shutdown after physical impact, interrupting insulin delivery in diabetic patients.

    Product
    MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851
    Category
    Medical Device
    Distribution
    53 states
  • SevereFDA (Devices)·Z-0002-2025·2024-10-09

    MiniMed Insulin Pumps Recalled for Battery Failure After Physical Impact

    MiniMed insulin pumps are recalled because physical impact can damage internal components, reduce battery life, and cause unexpected device shutdown that interrupts insulin delivery.

    Product
    MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 640G Insulin Pump, REF: MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, MMT-1752; MiniMed 720G Insulin Pump, REF: MMT-1809,
    Category
    Medical Device
    Distribution
    53 states
  • SevereNHTSA·24V753000·2024-10-09

    Harley-Davidson FXLRST and FXRST Motorcycles Recalled for Brake Line Damage

    Certain 2022-2024 Harley-Davidson FXLRST and 2022 FXRST motorcycles have brake lines that may contact the fuel tank and become damaged, risking loss of front brake function.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON FXLRST, FXRST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0022-2025·2024-10-09

    Cranberry Muffins Recalled for Undeclared Milk and Wheat Allergens

    The Posh Bakery is recalling Cranberry Muffins due to undeclared whey (milk) and wheat flour, as well as missing nutrition facts panel and allergen statement. Consumers with milk or wheat allergies should not consume these products.

    Product
    Whole Grains Bakery labeled "Cranberry Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090
    Category
    Food
    Distribution
    0 states
  • HighUSDA FSIS·028-2024·2024-10-09

    BrucePac Recalls Ready-to-Eat Meat and Poultry Due to Listeria

    BrucePac is recalling approximately 11.7 million pounds of ready-to-eat meat and poultry products due to possible Listeria monocytogenes contamination.

    Product
    BrucePac — BrucePac Recalls Ready-To-Eat Meat and Poultry Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·24V751000·2024-10-09

    Jayco Recalls 2025 Jay Feather Air Travel Trailers Due to Incorrect Weight Label

    Jayco is recalling 2025 Jay Feather Air travel trailers because the Gross Axle Weight Rating on the certification label is incorrect, which can allow the vehicle to be overloaded.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER JAY FEATHER AIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3304-2024·2024-10-09

    ADVIA Centaur aTPO Assay kits recalled due to positive result bias

    Siemens Healthcare is recalling 5,622 ADVIA Centaur aTPO Assay kits due to test accuracy issues. The affected lots produce results that are biased higher at and below the 60 U/mL threshold.

    Product
    ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0017-2025·2024-10-09

    Chocolate chip muffins recalled for undeclared milk and wheat

    The Posh Bakery is recalling Whole Grains chocolate chip muffins due to undeclared milk and wheat allergens with missing allergen labeling. Those with milk or wheat allergies should not consume this product.

    Product
    Whole Grains Bakery labeled "Choclate Chip Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090 UPC"7 13583 05 105 4"
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0005-2025·2024-10-09

    Sriracha Sauce Recalled for Manufacturing Without Proper Authorization

    Blue Tape Sriracha sauce (136 bottles, 10.5 oz each) was manufactured without the required authorization for producing acidified foods, creating potential safety risks.

    Product
    Blue Tape Sriracha sauce is refrigerated condiment, packaged in a 10.5oz clear squeeze bottle, sold individually. Ingredients: Chilies, Garlic, Capsicum, Sugar, Salt, White Wine Vinegar. There is no company address on the label and no UPC code.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0009-2025·2024-10-09

    BD FACSDuet Sample Preparation System software defect causes inaccurate specimen volumes

    The BD FACSDuet sample preparation system may dispense specimen volumes that are 3% to 20% higher in one tube versus another, leading to inaccurate blood counts, delayed test results, and potential additional blood collection. The defect affects 130 systems distributed across the US and internationally.

    Product
    BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-0018-2025·2024-10-09

    Blueberry muffins recalled for undeclared milk and wheat allergens

    The Posh Bakery, Inc. is recalling Whole Grains Blueberry Muffins (6 oz) due to undeclared milk (whey) and wheat flour, with missing allergen labeling and nutrition facts panel.

    Product
    Whole Grains Bakery labeled "Blueberry Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090 UPC"7 13583 05 102 3"
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0001-2025·2024-10-09

    Prescription atorvastatin bottles recalled for containing wrong medication

    A carbamazepine (anticonvulsant) tablet was found in bottles of atorvastatin (cholesterol medication). The affected lot includes 2,328 bottles distributed nationwide.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0001-2025·2024-10-09

    KARA BOONDHI Recalled for Undeclared Wheat Allergen

    Grace Imports is recalling KARA BOONDHI due to undeclared wheat allergen on the label. The affected product was distributed to retail stores in Georgia.

    Product
    KARA BOONDHI INGREDIENTS: Gram flour, Edible beg oil (Refined Palmolein Oil), Chilly powder, Curry leaf, pepper, Asafoetida, Corn Flour, Urid dhall, Black salt. Natural Antioxidant (Mixed Tocopherol INS 305) ALLERGEN INFORMATION: Made in a FActory that Process Peanuts, Tree nuts,
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0006-2025·2024-10-09

    Sqwincher Electrolyte Beverage Mix recalled for potential metal contamination

    Kent Precision Foods Group is recalling Sqwincher Electrolyte Beverage Mix (Orange powder, lot 2B0165712) due to potential metal contamination. The product was distributed in 11 states.

    Product
    Sqwincher Electrolyte Beverage Mix, Orange powder pack, Net Wt 47.66 oz (3lb) 1.35 kg: UPC 7588008834 / 16 per case / 5 gal yield item number 159016404
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0019-2025·2024-10-09

    Hemodialysis console blood leak sensor may fail to trigger alarm

    A component in certain Tablo Hemodialysis consoles may fail to detect small blood leaks promptly, potentially causing symptoms like hypotension, fatigue, and dizziness if undetected blood loss occurs.

    Product
    Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Drugs)·D-0007-2025·2024-10-09

    Pluvicto Radiopharmaceutical Drug Recalled Due to Manufacturing Quality Deviations

    Advanced Accelerator Applications is recalling 99 doses of Pluvicto (lutetium LU-177 injection) due to manufacturing quality deviations. The affected lots were distributed to six states.

    Product
    Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-61
    Category
    Drug
    Distribution
    6 states

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