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.

10051–10075 of 27206

  • 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-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-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 (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-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 (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-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-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-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-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-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-2558-2024·2024-08-21

    Merit Medical Convenience Kits with Recalled Syringes Pose Quality Risks

    Merit Medical is recalling convenience kits containing syringes with quality defects including leaks and breakage that may pose patient safety risks in cardiac and vascular procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/angioplasty kit), REF: K12T-10773 K12T-09284D K12T-10621 K12T-10800 K12T-12491 To support various vascular or cardiac dia
    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 (Food)·F-1706-2024·2024-08-21

    Alfa Supply Biscuit Mix Recalled for Undeclared Wheat Allergen

    Alfa Supply is recalling Abby's Best Biscuit Mix due to undeclared wheat allergen on the product label. The product was distributed to California, Florida, Virginia, Washington, and Bahrain.

    Product
    Abby's Best BISCUIT MIX NET WEIGHT 4 LBS. 8 OZ. (2.04 KG) INGREDIENTS: ENRICHED BLEACHED FLOUR***PARTIALLY HYDROGENATED VEGETABLE SHORTENING (CONTAINS SOYBEAN OIL) WITH EMULSIFIER***LEAVENING***BUTTERMILK, SALT, SUGAR, CALSIUM CARBONATE PACKED FOR ABBY'S BEST BY ALFA MANUFACTURIN
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2559-2024·2024-08-21

    Merit Medical catheter extractor kits recalled for syringe quality defects

    Merit Medical is recalling 3,631 catheter extractor convenience kits due to defective syringes with leaks and breakage. The identified quality issues may compromise patient safety during catheter removal.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Outake, REF CET200 and CET300, The Catheter Extractor is a catheter accessory device intended for minimally invasive removal of tunneled long term catheters. T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2616-2024·2024-08-21

    BioButton Remote Monitoring Device Software Accuracy Issue

    A software anomaly causes the BioButton remote monitoring wearable device to report skin temperature readings slightly out of specification, affecting accurate health data collection in home and healthcare settings.

    Product
    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
    Category
    Medical Device
    Distribution
    5 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-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-1729-2024·2024-08-21

    Pariva Marinated Labneh Bites Recalled Due to Mold Contamination

    Pariva LLC is recalling Pariva Marinated Labneh Bites Za'atar (8 oz) due to potential mold contamination. The product was distributed in seven Northeast states with best-by dates in October or December 2024.

    Product
    Pariva Marinated Labneh Bites Za'atar; 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, SESAME SEEDS, SPICES; CONTAINS: MILK, SESAME; Distributed by,
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2560-2024·2024-08-21

    Merit Medical Syringes in Convenience Kits Recalled for Leaks and Breakage

    Merit Medical convenience kits containing plastic syringes are recalled due to leaks, breakage, and quality defects that may pose a risk to patient health. Approximately 3,647 kits were distributed nationwide.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02 (Custom Syringe Kit), REF: K02-00873A, Inject fluids into, or withdraw fluids from, the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1731-2024·2024-08-21

    Pariva Marinated Labneh Bites Recalled for Potential Mold Contamination

    Pariva LLC recalls Marinated Labneh Bites due to potential mold contamination. Approximately 4,261 units were distributed across seven states.

    Product
    Pariva Marinated Labneh Bites Rosemary Garlic; 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, ROSEMARY SPICES; CONTAINS: MILK, Distributed by, Mayu
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2545-2024·2024-08-21

    Discrete Chemistry Analyzer Recalled Due to Carousel Malfunction

    Beckman Coulter is recalling 59 units of its Access 2 Immunoassay System Analyzer due to misaligned index wheels causing carousel motion errors that disable the analyzer and cancel patient tests.

    Product
    Discrete photometric chemistry analyzer for clinical use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2622-2024·2024-08-21

    Salivary Testosterone ELISA Quality Control Failure Invalidates Test Results

    DRG International is recalling Salivary Testosterone ELISA kits (Model SLV-3013) due to out-of-range quality controls that invalidate test runs and delay patient results. The recall affects 257 units distributed nationwide in six states.

    Product
    Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2638-2024·2024-08-21

    PICC Catheter Package Contains Wrong Length, Causing Procedural Delay

    Argon Medical Devices recalls PICC catheters that are mislabeled. Packages marked 26G/1.9Fr x 30cm actually contain 26G/1.9Fr x 50cm catheters, which could delay procedures.

    Product
    L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
    Category
    Medical Device
    Distribution
    4 states