The Recall Desk

Archive

December 2023 recalls

600 recalls were announced in December 2023.

What the numbers show

Critical
29
Severe
213
High
307
Moderate
49
Low
2

Of the 600 recalls this month scored against our rubric, 5% are Critical, 36% are Severe.

Which agencies issued them

401–500 of 600

  • HighFDA (Food)·F-0493-2024·2023-12-13

    BAPS Shayona Mohanthal recall for undeclared soy and dyes

    BAPS Shayona is recalling Mohanthal (chickpea flour fudge) distributed in six states due to undeclared soy and dyes (Yellow #5, #6). The product poses risk to consumers with soy allergies or sensitivities.

    Product
    BAPS SHAYONA Mohanthal Fudge-like sweet made with chickpea flour roasted in clarified butter Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53126 Contains: Milk, Nuts
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0460-2024·2023-12-13

    FDA Recalls Biliary Balloon Dilators Due to Detachment Risk

    Wilson-Cook Medical is recalling 941 biliary balloon dilators that may detach during use. Detachment could require doctors to retrieve the device with an endoscope, which may cause bleeding.

    Product
    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0435-2024·2023-12-13

    ProCurity hospital beds recalled for missing electrical safety testing

    Stryker is recalling ProCurity model 3009 patient beds because they lack required electrical safety testing, creating a risk of electrical shock or tissue burn. Affected units were distributed nationwide and internationally.

    Product
    ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0445-2024·2023-12-13

    Elekta Versa HD radiation therapy system detector arm uncontrolled extension risk

    Certain Elekta Versa HD radiation therapy systems may experience uncontrolled detector arm extension due to microswitch setup issues. This recall affects 451 systems worldwide.

    Product
    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0139-2024·2023-12-13

    FDA Recalls Trospium Chloride Extended-Release Capsules for Manufacturing Defect

    Padagis US LLC is recalling Trospium Chloride Extended-Release Capsules (60 mg) due to manufacturing defects where some capsules contain missing, broken, or extra tablets. The recall affects 7,032 bottles distributed nationwide.

    Product
    TROSPIUM CHLORIDE — TROSPIUM CHLORIDE (TROSPIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0444-2024·2023-12-13

    Radiation Therapy System Detector Arm Microswitch Defect May Cause Uncontrolled Extension

    Elekta is recalling 264 units of its Synergy Platform radiation therapy systems due to a microswitch defect that could cause uncontrolled extension of detector arms. The systems were distributed worldwide.

    Product
    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0424-2024·2023-12-13

    ProCuity Patient Beds Missing Electrical Safety Tests: Burn and Shock Risk

    Stryker ProCuity patient beds lack required electrical safety test values, posing risk of tissue burn or electrical shock to patients and healthcare workers.

    Product
    ProCuity bed series, model number 3009, item number: 300900000000,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2024·2023-12-13

    NovoTHOR Gen 2.0 Light Therapy Bed Canopy Detachment Due to Ball Stud Failure

    Thor Photomedicine is recalling 19 NovoTHOR Gen 2.0 red light therapy beds due to ball stud component failures that can cause canopy detachment or difficulty in lifting. The beds were distributed worldwide.

    Product
    NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0492-2024·2023-12-13

    Integra Cranial Access Kit recall due to outer packaging defect

    Integra LifeSciences is recalling the Integra Cranial Access Kit due to a defect in the outer packaging that can split and compromise device sterility. A total of 173 units are affected.

    Product
    Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V844000·2023-12-13

    2020-2022 Honda CR-V Hybrid battery cable recall due to missing fuse

    Honda recalls 2020-2022 CR-V Hybrid vehicles whose 12-volt battery cable is missing a fuse on the power circuit, which can cause short circuits or overheating during crashes and increase the risk of fire or injury.

    Product
    HONDA — HONDA CR-V HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0436-2024·2023-12-13

    Stryker ProCurity Hospital Beds Recalled for Missing Electrical Safety Tests

    Stryker is recalling ProCurity patient beds (model 3009) due to missing electrical safety test documentation. Affected beds pose a risk of electrical shock or tissue burns. Facilities should verify their bed serial numbers and contact Stryker.

    Product
    ProCurity bed series, model number 3009, item number: 3009PX-ZX-450.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0482-2024·2023-12-13

    HVAD Ventricular Assist Device Instructions Updated for Controller Alarm and Lifespan

    Heartware is updating instructions for the HVAD ventricular assist device to clarify controller fault alarm conditions and component useful life guidance for 126 units distributed worldwide.

    Product
    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0497-2024·2023-12-13

    BAPS Shayona fudge recalled for undeclared soy allergen

    BAPS Shayona Sangam Katri Rose and nut fudge is recalled because it contains undeclared soy. The product was distributed to six states: Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.

    Product
    BAPS SHAYONA Sangam Katri Rose and nut fudge Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53035 Contains: Nuts
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0425-2024·2023-12-13

    ProCuity Patient Beds Recalled for Missing Electrical Safety Tests

    Stryker Medical is recalling ProCuity bed series model 3009 due to missing electrical safety test values. The beds pose a risk of electrical shock or tissue burn to patients.

    Product
    ProCuity bed series, model number 3009, item number: 3009PX-L-100.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0507-2024·2023-12-13

    Stay Safe Cap Labeling Recall for Additional Safety Warnings

    Fresenius Medical Care is updating the Stay Safe Cap's labeling to include additional warnings and contraindications for potential side effects. No illnesses have been reported.

    Product
    Stay Safe Cap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0500-2024·2023-12-13

    Vermont Village Organic Apple Sauce recalled for elevated patulin levels

    Vermont Village Organic Unsweetened Apple Sauce (24oz) is being recalled due to elevated patulin levels. Consumers should not consume the product and should discard or return it.

    Product
    Vermont Village Organic Unsweetened Apple Sauce (24oz); UPC 362401 | 084648311285
    Category
    Food
    Distribution
    25 states
  • HighFDA (Devices)·Z-0459-2024·2023-12-13

    FDA Recalls Quantum TTC Biliary Balloon Dilators Due to Design Nonconformance

    Wilson-Cook Medical recalls 553 Quantum TTC Biliary Balloon Dilators that do not meet design specifications, creating risk of balloon detachment during endoscopic procedures.

    Product
    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0471-2024·2023-12-13

    Intraocular lens recall: EVO+VISIAN devices may not meet specifications

    Staar Surgical is recalling 15 EVO+VISIAN Implantable Collamer Lens devices due to potential specification failures. The devices may not meet design specifications.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighNHTSA·23V842000·2023-12-13

    Audi Electric Vehicles Recalled for Fire Risk in Charging Cable

    Audi is recalling select 2019-2024 electric vehicles due to fire risk from overheating 220V/240V home charging cables. Owners should stop using the affected cables and switch to 110V charging or public stations until replacement cables with temperature sensors are supplied.

    Product
    AUDI — AUDI E-TRON, A8, E-TRON GT, RS E-TRON GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0486-2024·2023-12-13

    Chest Drain Devices Re-sterilized Using Unapproved Process

    Atrium Oasis chest drain devices were re-sterilized by a third party using unapproved packaging and sterilization processes lacking manufacturer validation. Affected devices were distributed in Virginia.

    Product
    Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0458-2024·2023-12-13

    Biliary balloon dilators recalled for design non-conformance causing detachment

    Wilson-Cook Medical is recalling QUANTUM TTC biliary balloon dilators due to design non-conformance. The devices may detach during use, potentially requiring endoscopic retrieval that could cause bleeding.

    Product
    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0447-2024·2023-12-13

    Medical Radiation Therapy System Detector Arm Malfunction Poses Uncontrolled Extension Risk

    Elekta recalled its ELEKTA AXESSE radiation therapy system due to potential uncontrolled extension of detector arms if the microswitch is incorrectly configured. The recall affects 47 units distributed worldwide.

    Product
    ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0468-2024·2023-12-13

    EVO VISIAN intraocular lens recalled for potential specification non-compliance

    Staar Surgical recalls EVO VISIAN implantable intraocular lenses because they may not meet specifications. Patients with these implants should contact their ophthalmologist.

    Product
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0440-2024·2023-12-13

    Automated Impella Controller Software Issue Prevents Pump Detection

    Abiomed is recalling Automated Impella Controller (AIC) software versions V8.4 and V8.4.1 due to a software issue that may prevent the pump from being detected as connected to the controller. Devices were distributed in Arizona, California, Florida, New York, and Virginia.

    Product
    Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0454-2024·2023-12-13

    Red Light Therapy Bed Canopy Strut Detachment Risk Nationwide

    Thor Photomedicine is recalling six THOR NOVO GEN 2.0 XL whole body red light therapy beds due to ball stud component failure. The defect causes gas strut detachment, making the canopy difficult to lift.

    Product
    G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0496-2024·2023-12-13

    BAPS Shayona Burfi Sweetened Ricotta Fudge Recalled for Undeclared Soy

    BAPS Shayona burfi (sweetened ricotta fudge) is recalled due to undeclared soy allergen. The product was distributed to AL, FL, GA, NC, SC, and TN.

    Product
    BAPS SHAYONA Burfi Sweetened ricotta fudge Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53037 Contains: Milk
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0485-2024·2023-12-13

    Atrium Oasis Chest Drain Recalled Due to Invalid Sterilization Process

    Atrium Medical Corporation is recalling specific lots of Atrium Oasis Dry Suction Water Seal Chest Drains that were re-sterilized by a third party using unapproved methods and packaging. The invalid sterilization process lacks manufacturer validation and may compromise device sterility.

    Product
    Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0465-2024·2023-12-13

    FDA Class II Recall: Intraocular Lens Implants May Not Meet Specifications

    Staar Surgical is recalling 133 units of EVO+VISIAN intraocular lenses that may not meet manufacturing specifications. The affected devices were distributed across multiple U.S. states.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighNHTSA·23V840000·2023-12-13

    2021-2023 Porsche Taycan Battery Short Circuit Fire Risk

    Porsche is recalling 2021-2023 Taycan models due to a potential short circuit in the high-voltage battery that increases the risk of fire. Owners should contact Porsche customer service at 1-800-767-7243 for free inspection and repair.

    Product
    PORSCHE — PORSCHE TAYCAN 4 CROSS TURISMO, TAYCAN GTS SPORT TURISMO, TAYCAN, TAYCAN TURBO S CROSS TURI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0141-2024·2023-12-13

    Injectable ceFAZolin Sodium Recalled for Lack of Sterility Assurance

    Wells Pharma is recalling 825 syringes of injectable ceFAZolin sodium distributed in Philadelphia, Pennsylvania, due to lack of assurance that the product meets required sterility standards.

    Product
    ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0443-2024·2023-12-13

    Medical Radiation Therapy System Potential Detector Arm Malfunction Due to Microswitch Issue

    Recall of approximately 1,019 Elekta Synergy radiation therapy systems due to potential uncontrolled extension of detector arms if the middle arm microswitch is incorrectly setup.

    Product
    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0431-2024·2023-12-13

    ProCuity Bed Series Recalled for Electrical Safety Test Failures

    Stryker is recalling ProCuity patient beds (model 3009) for missing electrical safety test values, which presents risk of electrical shock or tissue burn.

    Product
    ProCuity bed series, model number 3009, item number: 3009PX-Z-450.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0492-2024·2023-12-13

    Coconut Fudge Recalled Due to Undeclared Soy Allergen

    BAPS Shayona is recalling Kopra Paak Coconut Fudge (12 oz, code A06D2023) for undeclared soy, a major allergen. The product was distributed to Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.

    Product
    BAPS SHAYONA Kopra Paak Coconut fudge Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53119 Contains: Milk
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0490-2024·2023-12-13

    BAPS Shayona sweet rolls recalled for undeclared artificial food dyes

    BAPS Shayona Kaju Pista Roll sweet rolls are being recalled because they contain undeclared Yellow #5, Yellow #6, and Blue 1 food dyes. The recall affects 138 units distributed to six southern states.

    Product
    BAPS SHAYONA Kaju Pista Roll Sweet rolls made from cashew and pistachio filling Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53068 Contains: Nuts
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0448-2024·2023-12-13

    Monarch Platform bronchoscope recalled for potential software image inversion

    AURIS Health is recalling the Monarch Platform virtual bronchoscope due to potential software issues that may flip the displayed surgical image, which could impair visualization during minimally invasive procedures.

    Product
    Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Food)·F-0498-2024·2023-12-13

    Milled Brown Flax Recalled Due to Plastic Contamination Risk

    Scoular Grain Co is recalling 40,000 pounds of Milled Brown Flax (lot REG23268) distributed in Texas and Canada due to plastic foreign object contamination. The product poses a choking and injury hazard if consumed.

    Product
    Milled Brown Flax - MBF9, 50lb bag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0456-2024·2023-12-13

    NovoTHOR Gen 2.5 XL Red Light Therapy Bed Canopy Gas Strut Detachment Recall

    Thor Photomedicine is recalling 26 NovoTHOR Gen 2.5 XL red light therapy beds due to ball stud component failure that can cause the gas strut to detach, making the canopy difficult to lift.

    Product
    NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0484-2024·2023-12-13

    Dietary supplement recalled for undeclared soy allergen

    Garden of Life RM-10 ULTRA dietary supplement recalled for undeclared soy. Approximately 8,940 bottles were distributed domestically and internationally.

    Product
    Garden of Life, RM-10 ULTRA, Ultimate Immune System Support60 Vegetarian Caplets, Whole Food Dietary Supplement, 90 Ultra Zorbe Vegetarian Capsules
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0498-2024·2023-12-13

    Integra Cranial Access Kit recalled due to packaging defect

    Integra LifeSciences Corp. is recalling 173 units of its Cranial Access Kit due to a packaging defect that can split and compromise device sterility. No illnesses have been reported.

    Product
    Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0432-2024·2023-12-13

    ProCuity Patient Beds Recalled for Missing Electrical Safety Tests

    Stryker's ProCuity bed series (model 3009) is being recalled due to missing electrical safety test documentation. The beds present a potential risk of electrical shock or tissue burn.

    Product
    ProCuity bed series, model number 3009, item number: 3009PX-ZM-450.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2024·2023-12-13

    Vyaire Flexible Patient Circuits 3100A Distributed Without U.S. Approval

    Vyaire's Flexible Patient Circuits (29028-004) for the 3100A ventilator were distributed in the U.S., despite being approved only for use outside the U.S. They do not meet U.S. regulatory requirements.

    Product
    vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0510-2024·2023-12-13

    VITROS ECO2 Chemistry Slides may produce inaccurate CO2 test results

    Ortho-Clinical Diagnostics is recalling certain VITROS ECO2 diagnostic slides that may produce inaccurate carbon dioxide measurements, potentially leading to misdiagnosis of acid-base balance disorders.

    Product
    VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600 XT 3400 Chemistry Systems and the VITROS 5600/ XT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0464-2024·2023-12-13

    EVO+VISIAN Implantable Collamer Lens Recalled for Specification Failure

    Staar Surgical is recalling 20 units of the EVO+VISIAN Implantable Collamer Lens due to a potential that implanted devices may not meet specifications. The recall affects units distributed across multiple US states.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0508-2024·2023-12-13

    DJO EMPOWR Knee System Recall: Incorrect Device in Packaging

    Encore Medical is recalling 37 DJO surgical EMPOWR Porous Knee System SIZE 8 devices distributed nationwide because incorrect product components were packaged with certain units.

    Product
    DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0439-2024·2023-12-13

    CardioQuip Modular Cooler-Heater Units Recalled for Heating Chamber Malfunction

    CardioQuip Modular Cooler-Heater units are being recalled due to a potential heating-chamber malfunction that could cause melting and burning of internal components. 125 units distributed across 15 US states are affected.

    Product
    CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0433-2024·2023-12-13

    ProCuity Hospital Bed Model 3009 Lacks Required Electrical Safety Tests

    Stryker Medical is recalling ProCuity hospital beds with missing electrical safety test documentation, creating risk of electrical shock or tissue burns.

    Product
    ProCuity bed series, model number 3009, item number: 3009PX-ZM-600.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0502-2024·2023-12-13

    Cooper Surgical catheter recall due to component detachment risk

    The Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr catheter may detach or leak due to defective bonding material used in assembly. The 73 affected units were distributed nationwide and internationally.

    Product
    Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes. Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0437-2024·2023-12-13

    DRX Revolution Mobile X-Ray System Electrical Component Failure Recall

    Carestream Health is recalling the DRX Revolution Mobile X-Ray System due to unexpected failure of electrical components in the CPI generator. The recall affects approximately 3,961 units distributed worldwide.

    Product
    DRX Revolution Mobile X-Ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2024·2023-12-13

    HeartWare HVAD: Documentation Updates for Controller Fault and Component Life

    Heartware is updating instructional materials for the HVAD ventricular assist device to clarify when Controller Fault alarms sound and how to troubleshoot them. Updates also address component useful life instructions.

    Product
    PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0462-2024·2023-12-13

    FDA Recalls Biliary Balloon Dilators for Design Nonconformance

    Wilson-Cook Medical Inc. is recalling 888 units of the Quantum TTC Biliary Balloon Dilator due to design nonconformance that could cause balloon detachment during use, potentially requiring endoscopic retrieval or causing bleeding.

    Product
    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0493-2024·2023-12-13

    Integra Cranial Access Kit packaging defect compromises device sterility

    Integra LifeSciences is recalling 59 Integra Cranial Access Kits due to outer packaging that can split without external force, compromising device sterility. Affected units (Lot 6837706, exp. 1-Mar-25) should be discontinued immediately.

    Product
    Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0473-2024·2023-12-13

    Intraocular Lens Implants Recalled for Specification Non-Compliance

    Staar Surgical recalls six EVO+VISIAN intraocular lens implants due to potential specification non-compliance. The affected units were distributed across 38 US states.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0490-2024·2023-12-13

    Blood Ketone Test Strips Recalled for False Negative Results

    Stanbio Laboratory is recalling STAT-Site M BHB Test Strips due to stability deterioration that causes false negative results. This defect may delay diagnosis and treatment of patients with conditions such as diabetic ketoacidosis.

    Product
    STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0427-2024·2023-12-13

    ProCuity Hospital Beds: Missing electrical safety tests pose burn and shock risk

    Stryker's ProCuity hospital beds (model 3009) lack electrical safety test values, creating a risk of tissue burns and electrical shock to patients. The beds were distributed nationwide and internationally.

    Product
    ProCuity bed series, model number 3009, item number: 3009PX-LE-400.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2024·2023-12-13

    Medical Catheter Set Recalled for Faulty Bonding Material

    CooperSurgical is recalling H/S ELLIPTOSPHERE CATH 5 FR Sets (169 units) due to incorrect bonding material that may cause component detachment or leakage, potentially delaying diagnostic procedures.

    Product
    Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V841000·2023-12-13

    Multiple Porsche electric vehicles: 220V charging cable fire risk recall

    Porsche is recalling multiple electric vehicle models due to fire risk from overheating 220V/240V charging cables. Owners should not use these cables and should instead use 110V charging or public stations.

    Product
    PORSCHE — PORSCHE PANAMERA 4S E-HYBRID, PANAMERA TURBO S E-HYBRID, TAYCAN 4 CROSS TURISMO, TAYCAN 4S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0441-2024·2023-12-13

    Automated Impella Controller Software Defect Affecting Pump Connection Detection

    Abiomed is recalling Automated Impella Controller units with software versions V8.4 and V8.4.1 because a software issue may prevent proper pump connection detection. Affected devices were distributed in Arizona, California, Florida, New York, and Virginia.

    Product
    Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Drugs)·D-0146-2024·2023-12-13

    Baxter Healthcare Injectable Ondansetron Recalled for Failed pH Specifications

    Baxter Healthcare Corporation is recalling approximately 6 million vials of Ondansetron Hydrochloride injection due to manufacturing defects where pH levels failed to meet specifications.

    Product
    ONDANSETRON HYDROCHLORIDE — ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0467-2024·2023-12-13

    Staar EVO +VISIAN Implantable Collamer Lens Recalled for Specification Compliance Issue

    Staar Surgical is recalling EVO +VISIAN Implantable Collamer Lens devices due to a potential that the devices may not meet specifications. Patients should consult their eye care provider.

    Product
    EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0430-2024·2023-12-13

    ProCuity Hospital Patient Beds Recalled for Missing Electrical Safety Testing

    Stryker is recalling ProCuity bed series model 3009 because they are missing electrical safety test values, presenting a risk of tissue burn or electrical shock to patients.

    Product
    ProCuity bed series, model number 3009, item number: 3009PX-LEX-450.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0142-2024·2023-12-13

    Children's Acetaminophen Suspension Recalled for Failed Impurity Specifications

    KinderFarms is recalling KinderMed KIDS' PAIN & FEVER Acetaminophen oral suspension nationwide due to failed impurity and degradation specifications that do not meet FDA standards.

    Product
    PAIN AND FEVER — PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0449-2024·2023-12-13

    Monarch Platform Bronchoscope Software Issue Causes Flipped Display

    Auris Health is recalling 110 units of the Monarch Platform bronchoscope due to a software defect that may flip the image display. This inverted view could impact visualization during airway procedures.

    Product
    Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Food)·F-0503-2024·2023-12-13

    Hans Kissle Potato Salad recalled for undeclared egg and soy

    Hans Kissle Potato Salad White Homestyle (10 lb. bulk cases) is being recalled for undeclared egg and soy allergens. The recall affects units distributed in Connecticut and Massachusetts with a use-by date of November 25, 2023.

    Product
    Hans Kissle Potato Salad White Homestyle, 10 lb. bulk case, UPC Codes: 00036217701003
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0484-2024·2023-12-13

    Atrium Firm PVC Thoracic Catheter Recalled for Sterilization Nonconformance

    Atrium Medical Corporation is recalling 2,460 units of the Atrium Firm PVC Thoracic Catheter 36FR Straight due to sterilization nonconformance that caused premature product aging and inaccurate expiration dating. Facilities in 14 U.S. states are affected.

    Product
    Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-0487-2024·2023-12-13

    Bundi Ladoo recalled for undeclared artificial food dyes Yellow 5, Red 40, Green 3

    BAPS Shayona Bundi Ladoo was recalled because it contains undeclared artificial food dyes: Yellow 5, Red 40, and Green 3.

    Product
    BAPS SHAYONA Bundi Ladoo Sweet chickpea flour pearls rolled into spheres Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53094 Contains: Milk, Nuts
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0472-2024·2023-12-13

    Intraocular Lens Implants Recalled Due to Potential Specification Non-Compliance

    Staar Surgical is recalling 11 EVO+VISIAN implantable collamer lenses distributed across 38 US states because they may not meet manufacturing specifications. No illnesses or injuries have been reported.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0450-2024·2023-12-13

    Monarch Platform Bronchoscopy Device Recalled for Software Image Inversion

    AURIS HEALTH INC is recalling approximately 110 units of the Monarch Platform bronchoscopy surgical device due to a software defect that can flip the displayed image during procedures. No injuries have been reported.

    Product
    Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-0497-2024·2023-12-13

    Integra Cranial Access Kit recalled over outer packaging defect

    Integra LifeSciences recalled the Integra Cranial Access Kit (160 units) due to a defect in the outer packaging that can split and compromise device sterility, creating an infection risk for neurosurgical procedures.

    Product
    Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0428-2024·2023-12-13

    ProCuity Patient Beds Recalled Missing Electrical Safety Test Values

    Stryker is recalling ProCuity patient beds (model 3009) for missing required electrical safety test documentation, creating a risk of electrical shock or tissue burn.

    Product
    ProCuity bed series, model number 3009, item number: 3009PX-LE-450.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0434-2024·2023-12-13

    ProCurity patient beds recalled for electrical safety testing defects

    Stryker is recalling ProCurity bed series (model 3009) due to missing electrical safety test values that could pose risk of electrical shock or tissue burn. Affected units were distributed nationwide and internationally.

    Product
    ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0485-2024·2023-12-13

    BAPS Shayona Anjir Roll recalled for undeclared Yellow #5

    BAPS Shayona is recalling its Anjir Roll sweet rolls (12 oz) for containing undeclared Yellow #5 food coloring. The product was distributed to Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.

    Product
    BAPS SHAYONA Anjir Roll Sweet rolls made from fig and nut filling Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53005 Contains: Milk, Nuts
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0491-2024·2023-12-13

    BAPS Shayona Kesar Penda Ricotta Fudge Recalled for Undeclared Soy and Dyes

    BAPS Shayona is recalling Kesar Penda Ricotta fudge discs because they contain undeclared soy and Yellow #5 & #6 dyes. The product was distributed to six Southern states.

    Product
    BAPS SHAYONA Kesar Penda Ricotta fudge discs flavored with saffron Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53150 Contains: Milk
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0483-2024·2023-12-13

    Garden of Life Mushroom Supplement Recalled for Undeclared Soy

    Garden of Life RM-10 mushroom supplement recalled due to undeclared soy, a common allergen. The recall affects 15,119 bottles distributed domestically and internationally; consumers with soy allergies should not use these products.

    Product
    Garden of Life, RM-10, Organically Grown Mushrooms, 60 Vegetarian Caplets, Whole Food Dietary Supplement
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0482-2024·2023-12-13

    Dietary Supplement Recalled for Undeclared Soy Allergen

    Garden of Life FYI ULTRA Joint & Cartilage Formula dietary supplement recalled due to undeclared soy. Consumers with soy allergies should not use affected bottles.

    Product
    Garden of Life, FYI ULTRA, ULTIMATE Joint & Cartilage Formula, Whole Food Dietary Supplement, 120 Ultra Zorbe VEGETARIAN CAPSULES
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0442-2024·2023-12-13

    Medical Radiation Therapy Device Microswitch May Cause Uncontrolled Detector Arm Extension

    Elekta radiation therapy accelerators may experience uncontrolled detector arm extension due to an incorrectly set microswitch in the middle arm. The issue affects 315 units worldwide.

    Product
    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0463-2024·2023-12-13

    Quantum TTC Biliary Balloon Dilator Recall Due to Balloon Detachment Risk

    Wilson-Cook Medical is recalling 157 Quantum TTC Biliary Balloon Dilator devices due to a design defect that may cause balloon detachment during use, potentially requiring emergency retrieval.

    Product
    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0487-2024·2023-12-13

    Remington Medical drainage bags recalled due to packaging label date error

    Remington Medical is recalling drainage bags (Lot 2325111) due to errors in the 'Use by Date' and 'Date of Manufacturer' on box labels. Approximately 3,080 units distributed in PA and FL are affected.

    Product
    Remington MEDICAL Drainage Bag, REF 600-D;
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0481-2024·2023-12-13

    Ventricular Assist Device Instructions Updated for Alarm and Useful Life Clarification

    Heartware is updating instructions for HVAD ventricular assist device implant kits to clarify Controller Fault alarm conditions and troubleshooting steps, as well as useful life information for system components.

    Product
    PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0475-2024·2023-12-13

    HVAD Ventricular Assist Device Instructions Updated for Alarm Clarification

    Heartware, Inc. is updating instructions for the HVAD ventricular assist device to clarify Controller Fault alarm conditions and component useful life. The recall affects 45 units distributed worldwide.

    Product
    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0137-2024·2023-12-13

    Bupropion Hydrochloride Extended-Release Tablets Recalled for Failed Dissolution

    Sun Pharmaceutical is recalling Bupropion Hydrochloride Extended-Release Tablets 200 mg due to failed dissolution specifications. The recall affects 2,016 bottles with lot HAD0630A distributed nationwide.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0479-2024·2023-12-13

    HeartWare HVAD Implant Kit Instructional Update for Fault Alarms

    The FDA is issuing updated instructions for the HeartWare HVAD ventricular assist device to clarify when controller fault alarms sound and when device components should be replaced. No patient harm has been reported.

    Product
    PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0494-2024·2023-12-13

    BAPS Shayona Motichur Ladoo recalled for undeclared Yellow #5 and Yellow #6 dyes

    BAPS Shayona is recalling approximately 674 units of Motichur Ladoo across six states due to undeclared Yellow #5 and Yellow #6 food dyes discovered during an FDA inspection.

    Product
    BAPS SHAYONA Motichur Ladoo Sweet chickpea flour mini-pearls rolled into spheres Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53160 Contains: Milk
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0506-2024·2023-12-13

    TENS Devices Recalled for Missing Instruction Manual Warnings

    Liberty Medical Solutions is recalling 473 Multi-Mode TENS stimulator units distributed in five states due to missing warnings and contraindications in instruction manuals.

    Product
    Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0140-2024·2023-12-13

    LET Gel Topical Anesthetic Recalled Due to Incorrect Product Formulation

    Right Value Drug Stores is recalling LET Gel topical anesthetic syringes nationwide due to incorrect product formulation. Patients should not use affected syringes and should consult their healthcare provider.

    Product
    LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe, 10/pack, Rx only, Carie Boyd Pharmaceuticals, 8400 Esters Blvd, Ste# 190, Irving, TX 75063, NDC73271-1003-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0469-2024·2023-12-13

    EVO VISIAN Intraocular Lens Recalled Due to Specification Concerns

    Staar Surgical Company is recalling EVO VISIAN Implantable Collamer Lens devices due to potential specification defects. Two units distributed across the United States are affected.

    Product
    EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-0451-2024·2023-12-13

    Blood Culture Identification Panel Quality Control Test Reporting Issue

    BioFire Diagnostics is recalling BIOFIRE Blood Culture Identification 2 (BCID2) Panels due to instrument characteristic changes that cause Candida tropicalis to be detected but reported as 'Not Detected' in quality control testing.

    Product
    BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0470-2024·2023-12-13

    Intraocular Lens Devices May Not Meet Manufacturing Specifications

    Staar Surgical is recalling 3 units of its EVO+VISIAN Implantable Collamer Lens (phakic toric) due to a potential that devices may not meet specifications. No illnesses or injuries have been reported.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-0488-2024·2023-12-13

    Vyaire Flexible Patient Circuit 3100A Distributed Without U.S. Approval

    Vyaire Medical recalled 188 Flexible Patient Circuit 3100A units distributed in Florida that were approved only for use outside the United States. The circuits were mistakenly distributed in the U.S. market.

    Product
    vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0500-2024·2023-12-13

    Luminex VERIGENE BC-GP Utility Trays Recalled Due to Potential Defects

    Luminex Corporation is recalling 222 kits (4,440 VERIGENE BC-GP Utility Trays) used in blood culture testing due to potentially defective utility trays. The affected lot (062123018C) expires December 20, 2023.

    Product
    Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0486-2024·2023-12-13

    Almond and pistachio fudge recalled for undeclared color additives

    BAPS Shayona is recalling Badam Pista Sandwich due to undeclared Yellow #5 and Green 3 color additives. The product was distributed to six states.

    Product
    BAPS SHAYONA Badam Pista Sandwich Almond and pistachio layered fudge Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53009 Contains: Nuts
    Category
    Food
    Distribution
    6 states
  • HighNHTSA·23V838000·2023-12-12

    Tesla Model Y Autosteer Recall: Software Update for Control Prominence

    Tesla is recalling 2.03 million 2012-2023 Model S/X/3/Y vehicles with Autosteer due to insufficient control prominence that may allow driver misuse and crash risk. A free OTA software update will be provided.

    Product
    TESLA — TESLA MODEL S, MODEL X, MODEL 3, MODEL Y
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V837000·2023-12-12

    Mazda Recalls B-Series Trucks for Incorrect Air Bag Installation

    Mazda is recalling 2004-2006 B-Series trucks because previously replaced front passenger air bag inflators may have been installed incorrectly, potentially preventing proper inflation during a crash.

    Product
    MAZDA — MAZDA B-SERIES TRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V833000·2023-12-08

    American Coach American Eagle Motorhomes Recalled for Deflector Bracket Defect

    REV Recreation Group is recalling 2016-2023 American Coach American Eagle motorhomes because turbulence may loosen or break the rear air deflector mounting bracket hardware.

    Product
    AMERICAN COACH — AMERICAN COACH AMERICAN EAGLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V836000·2023-12-08

    2023 Harley-Davidson FLHXSE Motorcycles Engine Control Software Defect

    Harley-Davidson is recalling certain 2023 FLHXSE motorcycles due to an engine control module software defect that may cause loss of control at high speeds, increasing crash risk.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON FLHXSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V835000·2023-12-08

    Mercedes-Benz Recalls 2021-2022 GLE Models Due to Fire Risk

    Mercedes-Benz is recalling 2021-2022 GLE 350 and GLE 450 vehicles because a 12-volt ground connection may overheat, increasing the risk of a fire.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 350, GLE 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V834000·2023-12-08

    Forest River Recalls 2024 XLR Boost Toy Haulers for Taillight Defect

    Forest River is recalling 2024 XLR Boost toy haulers because taillights may be insufficiently reflective, reducing visibility and increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER XLR BOOST TOYHAULER
    Category
    Vehicle
    Distribution
    Distributed nationwide

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