The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

10026–10050 of 27206

  • SevereFDA (Food)·F-1703-2024·2024-08-21

    Boars Head Ham Recalled Due to Potential Listeria Monocytogenes Contamination

    Publix Super Markets is recalling 2,786 units of Boars Head Grab and Go Wedge Ham products due to potential Listeria monocytogenes contamination. The affected products were sold at retail locations in Florida and Georgia.

    Product
    Boars Head Grab and Go Wedge Ham, Smoke Master Black Forest Ham, Grab and Go Sandwich, NET WT. 7.5 OZ (213 g), Plastic Container, KEEP REFRIGERATED
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1734-2024·2024-08-21

    Lunds & Byerlys Smokin' Guacamole Dip recalled due to Listeria contamination

    Metro Produce Distributors is recalling Lunds & Byerlys Smokin' Guacamole Dip due to possible Listeria monocytogenes contamination. The 10 oz product was distributed in Minnesota.

    Product
    Lunds & Byerlys Smokin' Guacamole Dip, Net Wt 10 oz (283g). UPC 0 72431-66130 3. Keep Refrigerated.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1735-2024·2024-08-21

    Lunds & Byerlys Guacamole Dip Recalled for Listeria Risk

    Metro Produce Distributors is recalling 66 units of Lunds & Byerlys Pico de Gallo/Guacamole Dip distributed in Minnesota due to potential Listeria monocytogenes contamination. Consumers should not consume the product.

    Product
    Lunds & Byerlys Pico de Gallo / Guacamole Dip, Net Wt 18 oz (510g). UPC 0 72431-02993 6. Keep Refrigerated.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2572-2024·2024-08-21

    Merit Medical Convenience Kits with Defective Syringes Recalled

    Merit Medical convenience kits containing defective syringes are being recalled for leaks and breakage that may pose a risk to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude Prestige (Introducer Catheter), REF: PLP-2505/A PLP-2514/A PLP-2516/A The introduction of various types of pacing/defibrillator leads and catheters i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2571-2024·2024-08-21

    Merit Medical Convenience Kits with Recalled Syringes Pose Leak Risk

    Merit Medical is recalling 900 convenience kits containing plastic syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG (Introducer Catheter), REF: FCL-069-00/A FCL-069-02/A FCL-069-03/A For the introduction of various types of pacing or defibrillator leads and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2621-2024·2024-08-21

    Surgical Lighting Equipment Recalled for Cracked Welds and Frame Detachment Risk

    Aurora Series surgical light heads are recalled due to cracked welds on the frame. The defects can cause the frame to sag, housing to crack, or the light head to detach.

    Product
    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (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-2574-2024·2024-08-21

    Merit Medical cardiac kits contain plastic syringes with quality defects

    Merit Medical convenience kits used in cardiac procedures contain plastic syringes with potential leaks and breakage. The defects were identified following an FDA Safety Alert issued March 19, 2024.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Catheter kit), REF: For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2573-2024·2024-08-21

    Merit Medical Convenience Kits Recalled Due to Defective Syringes

    Merit Medical convenience kits containing recalled plastic syringes have quality issues including leaks and breakage that may pose risks during vascular and cardiac procedures. Approximately 5,700 affected kits were distributed nationwide.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/Angioplasty kit), REF: OPT0242-00 S1279-01 S2953 S2960 S6002 To support various vascular or cardiac diagnostic and interv
    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 (Devices)·Z-2576-2024·2024-08-21

    Medical paracentesis procedure kits recalled for syringe leaks and breakage

    Merit Medical is recalling paracentesis procedure kits nationwide containing syringes with identified leaks and breakage. The defects may pose a risk to patient health during medical procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Safety Paracentesis Procedure Tray (Paracentesis Tray kit), REF: SPPT-100/D SPPT-5F-10/D SPPT-5F-10L/B SPPT-5F-10S SPPT-5F-12PL SPPT-5F-17PL SPPT-5F-7/D SP
    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-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 (Drugs)·D-0632-2024·2024-08-21

    Ophthalmic solution recalled for defective container with lodged spike

    FDC Limited recalls Timolol Maleate eye drops (362,544 bottles) nationwide due to a manufacturing defect: a yellow spike from the cap lodged in the nozzle, posing a risk of eye injury.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    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-1704-2024·2024-08-21

    Fox's u-bet Sugar-Free Chocolate Syrup Recalled for Microbiological Contamination Risk

    SUBCO FOODS INC is recalling 137 cases of Fox's u-bet Sugar-Free Chocolate Flavored Syrup due to elevated pH and water activity levels indicating potential microbiological contamination and food-borne illness risk.

    Product
    Fox's u-bet Sugar-Free Chocolate Flavored Syrup, 18oz, UPC 070216246004, 12 retail units per wholesale case
    Category
    Food
    Distribution
    5 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-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
  • HighFDA (Devices)·Z-2544-2024·2024-08-21

    Beckman Coulter DxI 9000 Access analyzer software causes delayed test results

    Beckman Coulter has recalled 183 DxI 9000 Access analyzers due to a software issue that causes delays in test result reporting. When connected to a Laboratory Automation System, software versions 1.17 and below send out-of-sequence messages, potentially delaying patient treatment.

    Product
    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2617-2024·2024-08-21

    Spinal Cord Stimulation Devices May Reset During Charging, Causing Transient Therapy Loss

    Boston Scientific spinal cord stimulation implants may reset during routine charging, causing brief loss of therapy. Patients may experience undesired sensations when stimulation restarts, potentially leading to surgical intervention requests.

    Product
    WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
    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-2618-2024·2024-08-21

    Aurora 7 Surgical Light Heads Recalled for Cracked Weld Frames

    DKK Dai-Ichi Shomei is recalling 555 Aurora 7 surgical light heads because frame welds can crack, causing the frame to sag, the housing to crack, or the light head to detach.

    Product
    Aurora Series, Aurora 7 lighthead; Models: LED7 (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-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-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 (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-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