The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

7676–7700 of 52968

  • HighFDA (Devices)·Z-2568-2024·2024-08-21

    Merit Medical convenience kits recalled for syringe leaks and breakage risks

    Merit Medical is recalling convenience kits containing syringes with quality defects including leaks and breakage. The recalled kits may pose a risk to patients undergoing vascular and cardiac procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22C (Vein Tray Angiography kit), REF: K09T-11796F K12T-01558G K12T-01558H K12T-01822 K12T-01852L K12T-02006J K12T-02054 K12T-02091G K12T-02102B K12T-023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2619-2024·2024-08-21

    Surgical Lights Recalled for Possible Weld Defect and Frame Detachment

    DKK Dai-Ichi Shomei Co., Ltd. is recalling 822 Aurora surgical light heads due to a weld defect that could cause the light head to sag, crack, or detach during use.

    Product
    Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2586-2024·2024-08-21

    Heated Eye Mask Recalled Due to Detachable Wires and Burn Risk

    EYE COMFORT CARE LLC is recalling the UNclog Eye Mask due to safety clips that may allow wires to detach, potentially causing electrical shorts and burn injuries.

    Product
    Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Component: Heating unit, wire
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2584-2024·2024-08-21

    Cepheid Sample Collection Device May Leak Causing Cross-Contamination Risk

    Cepheid specimen collection devices may leak after patient samples are inserted, creating risk of biohazard exposure and false positive test results. Affected devices are distributed in medical testing facilities worldwide.

    Product
    Cepheid, Sample Collection Device, Part: 900-0370
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2024·2024-08-21

    Merit Medical convenience kits recalled for syringe leaks and breakage

    Merit Medical is recalling 1,390 convenience kits containing plastic syringes with identified quality issues including leaks and breakage. The kits, distributed nationwide, may pose a risk to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF:K04-00791A An intravascular administration set is a device used to administer fluids from a container to a patient's vascular syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2579-2024·2024-08-21

    Merit Medical Convenience Kits Recalled for Syringe Leaks and Breakage

    Merit Medical is recalling medical convenience kits with defective syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health during procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K05-02166B K05T-00380C K05T-01674B K05T-01863 K05T-01941C K05T-01955 K05T-02138 K05T-02159 K05T-02272G K05T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2562-2024·2024-08-21

    Merit Medical Convenience Kits with Defective Syringes Recalled

    Merit Medical convenience kits containing plastic syringes are recalled due to leaks, breakage, and quality issues that may pose risks to patients undergoing cardiac and vascular procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF: K05-00203M K05-00511J K05-00547J K05-00612Q K05-00819A K05-01030H K05-01274D K05-01646 K05-01688A K05-01717B K05-01880K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2620-2024·2024-08-21

    Surgical light heads may detach due to weld defects

    DKK Dai-Ichi Shomei is recalling 293 Aurora surgical light heads because the frame welds can crack, potentially causing the light head to detach during use. No injuries have been reported.

    Product
    Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1710-2024·2024-08-21

    Jalapeno Peppers from RS Hanline Recalled for Potential Listeria Contamination

    RS Hanline and Company Inc is recalling jalapeno peppers due to potential contamination with Listeria monocytogenes. The affected products were distributed across nine states.

    Product
    Jalapeno peppers packaged as 5lb diced with 2 bags per case, whole as 10lb carton, or whole as 5lb carton
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2564-2024·2024-08-21

    FDA recalls Merit Medical convenience kits due to defective syringes

    Merit Medical convenience kits containing plastic syringes are recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected kits are used for vascular and cardiac procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09/K09T (Custom Manifold Kit), REF: K09-00526L K09-00807AH K09-01467AD K09-01467AF K09-01514U K09-01734L K09-02040C K09-02683F K09-02804B K09-03844F K0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2583-2024·2024-08-21

    HeartMate 3 System Controller membrane may lift, risking fluid damage and device failure

    Thoratec LLC is recalling 694 HeartMate 3 System Controllers because the UI membrane may lift along the housing, allowing fluid entry that could damage internal circuits and cause loss of power or pump failure.

    Product
    HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Kit, US, Model: 106524US; HeartMate 3 LVAS Implant Kit, OUS, Model: 106524INT; HeartMate 3 System
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Food)·F-1730-2024·2024-08-21

    Pariva Marinated Labneh Bites Recalled Due to Potential Mold Contamination

    Pariva LLC is recalling Pariva Marinated Labneh Bites Mild Tandoori due to potential mold contamination. Affected products were distributed in Massachusetts, Maine, New Hampshire, Rhode Island, New York, New Jersey, and Connecticut.

    Product
    Pariva Marinated Labneh Bites Mild Tandoori; NET WT 8 OZ (225g); INGREDIENTS: YOGURT (CULTURED PASTEURIZED GRADE A MILK & CREAM, SKIM MILK, WHEY PROTEIN CONCENTRATE, SALT AND PECTIN), *SUNFLOWER OIL, *EXTRA VIRGIN OLIVE OIL, SPICES; CONTAINS: MILK, Distributed by, Mayur, LLC, 196
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2413-2024·2024-08-21

    Dental X-Ray Device Testing Defect May Affect Image Repeatability

    Palodex Group Oy recalls the Orthopantomograph OP300 dental x-ray system due to a testing software defect that may allow devices with poor image repeatability to be distributed.

    Product
    Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2563-2024·2024-08-21

    Merit Medical convenience kits with syringe quality issues recalled nationwide

    Merit Medical is recalling convenience kits containing syringes with quality issues including leaks and breakage that may pose a risk to patients receiving intravenous fluid administration.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2565-2024·2024-08-21

    Merit Medical Convenience Kits With Recalled Syringes Pose Quality Defect Risks

    Merit Medical convenience kits containing recalled syringes are subject to a nationwide recall due to quality defects including leaks and breakage that may pose risks to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Management Kit), REF: K10T-05815 K10T-05816 K10-04722C K10-03591KP K10-05530 K10-04291AP K10-04386CP K10T-05227 K10-05120P K10-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1702-2024·2024-08-21

    Full Circle Frozen Dessert Recalled for Undeclared Cashew Allergen

    Full Circle Coconut Milk Chocolate Almond Crunch frozen dessert is recalled due to undeclared cashews. Product labels show mismatch: carton states 'coconut milk' but top states 'cashew milk,' and product contains cashew milk.

    Product
    FULL CIRCLE market COCONUTMILK CHOCOLATE ALMOND CRUNCH NON0DAIRY FROZEN DESSERT 16 FLOZ (1PT) 473 mL UPC 0 36800 46964 8 DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2577-2024·2024-08-21

    Merit Medical Catheter Kits Recalled for Syringe Leaks and Breakage Issues

    Merit Medical convenience kits containing defective plastic syringes are being recalled due to leaks, breakage, and quality issues that may harm patients. The recall affects approximately 4,027 kits distributed nationwide.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF: FCL-083-02/A WOR-CSG-B1-09/A WOR-CSG-B2-09/A WOR-CSG-BL1-09/A WOR-CSG-E-90/A For the int
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2585-2024·2024-08-21

    Medical Device Recall: BD Kiestra Urine Culture Software May Cause Inaccurate Results

    Becton Dickinson & Co. is recalling the BD Kiestra Urine Culture Application due to a software issue that may cause inaccurate bacterial colony counts. This could impact patient diagnosis and treatment decisions.

    Product
    BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2557-2024·2024-08-21

    Merit Medical convenience kits recalled for syringe leaks and breakage

    Merit Medical convenience kits containing recalled syringes have quality issues including leaks and breakage that may pose a risk to patient health. The recall affects 2,388 kits distributed nationwide.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management System Kit, REF BRC-BAL-INT-SL/B An endoscope and accessories is a device used to provide access, illumination, and allow observ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24T008000·2024-08-20

    Continental Recalls HDL2 DL+ Tires Due to Belt Separation Risk

    Continental is recalling specific HDL2 DL+ tires because an incorrect rubber compound may cause the steel belt to separate, potentially leading to a loss of vehicle control.

    Product
    TIRES:TREAD/BELT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V622000·2024-08-19

    Northern Lite Truck Camper Recall for Cooktop Overheating Risk

    Northern Lite is recalling 2022-2024 Truck Campers because a cooktop circuit board may overheat, increasing the risk of a fire.

    Product
    NORTHERN LITE — NORTHERN LITE TRUCK CAMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V618000·2024-08-16

    Winnebago Recalls Travel Trailers Due to Incorrect Electrical Outlet Installation

    Winnebago is recalling certain Minnie, Access, and Voyage travel trailers because a standard outlet may be installed where a GFCI protected outlet is required, increasing the risk of electric shock.

    Product
    WINNEBAGO — WINNEBAGO ACCESS, MINNIE, VOYAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-08162024-01·2024-08-16

    USDA Issues Public Health Alert for Illegally Imported Myanmar Meat and Poultry

    USDA FSIS issued a public health alert for meat and poultry products illegally imported from Myanmar, a country ineligible to export to the U.S.

    Product
    FSIS Issues Public Health Alert for Ineligible Meat and Poultry Products Illegally Imported from the Republic of the Union of Myanmar
    Category
    Food
    Distribution
    Distributed nationwide