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.

9926–9950 of 27089

  • 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-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 (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-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-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-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-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
  • 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-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 (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-1737-2024·2024-08-21

    Bovine Collagen Peptide Powder Recalled for Potential Salmonella Contamination

    Bovine collagen peptide powder manufactured by Nanjing NutraBuilding Bio Tech is being recalled due to potential Salmonella contamination. Affected batches were distributed in Wisconsin.

    Product
    Bovine Collagen Peptide. Powder, Grade A, Cowhide Source. Net Weight: 20.0 kg. Made in China.
    Category
    Food
    Distribution
    1 state
  • 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 (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-2569-2024·2024-08-21

    Merit Medical pericardiocentesis kits recalled for syringe defects

    Merit Medical convenience kits containing plastic syringes have been recalled nationwide. The syringes have quality issues including 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: PC (Pericardiocentesis Tray - Fluid drainage tray), REF: PC101/B PC801 PC801/A PC802 PC802/A The Pericardiocentesis Kit is intended to withdraw fluid from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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-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-2570-2024·2024-08-21

    Merit Medical Convenience Kits Recalled for Defective Plastic Syringes

    Merit Medical is recalling 7,442 convenience kits containing defective syringes that may leak or break, posing a risk to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSolve (Catheter and Tip Suction kit), REF: RTT14038MB/A The ReSolve Thoracostomy Tray is indicated for the percutaneous removal of air and fluid from the pleu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2575-2024·2024-08-21

    Merit Medical Cardiac Catheter Kits Recalled for Syringe Leaks and Breakage

    Merit Medical's Prelude SNAP-H cardiac catheter kits are being recalled because their syringes may leak or break during use, potentially affecting cardiac procedures. No illnesses have been reported.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP-H (Introducer Catheter kit), REF: PLSH-1006/A PLSH-1007/A PLSH-1008/A PLSH-1009.5/A PLSH-2506/A PLSH-2507/A For the introduction of various t
    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 (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-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 (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
    0 states