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.

20026–20050 of 88183

  • HighFDA (Devices)·Z-1242-2023·2023-03-22

    BD Insulin Syringes Recalled for Nonsterile Condition and Infection Risk

    Becton Dickinson is recalling 686,500 units of BD insulin syringes due to a nonsterile condition that may expose patients to pathogenic microorganisms and risk of infection.

    Product
    BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit Scale-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1247-2023·2023-03-22

    TFN-Advanced Femoral Nails May Have Incorrect Length Markings

    Synthes TFN-Advanced Femoral Nails labeled as 200mm may measure 170mm, and vice versa. Healthcare providers should verify actual dimensions before surgical use.

    Product
    TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0469-2023·2023-03-22

    Eye allergy medication recalled for out-of-specification impurity

    Teva Pharmaceuticals is recalling 715,632 bottles of Clear Eyes Once Daily eye drops due to an out-of-specification impurity found during stability testing.

    Product
    Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL (0.085 fl oz) bottle, Sterile, Distributed by Medtech Products Inc. Tarrytown, NY 10591, A Prestige Consumer Healthcare company, Made in Israel, UPC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1243-2023·2023-03-22

    BD Ultra-Fine Insulin Syringes Recalled Due to Nonsterile Condition

    Becton Dickinson is recalling BD Ultra-Fine Insulin Syringes (Catalog Number 326719) due to a nonsterile condition that could expose patients to pathogenic microorganisms and local infection. Approximately 80,500 units distributed worldwide are affected.

    Product
    BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326719
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0423-2023·2023-03-22

    Sheetz M.T.go Turkey Deli Sandwich recalled for undeclared sesame allergen

    Sheetz Distribution Services is recalling 10,361 M.T.go Turkey Deli Sandwiches due to undeclared sesame. Consumers with sesame allergies face potential serious allergic reactions.

    Product
    Sheetz M.T.go! Made To Go Turkey Deli Sandwich. The products are packaged in 4.75 oz. clear, plastic clamshells with the following UPC 759465001854 (Turkey).
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1245-2023·2023-03-22

    Fusion Bioline Vascular Graft recalled due to manufacturing straightness defect

    Maquet Cardiovascular is recalling one Fusion Bioline Vascular Graft from lot 25162546 that failed straightness testing. The graft could reduce blood flow or cause tension, potentially leading to bleeding and pseudo-aneurysm.

    Product
    Fusion Bioline Vascular Graft, Part number M00201503046B0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0435-2023·2023-03-22

    White Confectionery Chocolate Drop May Contain Undeclared Peanut Residue

    Clasen Quality Chocolater is recalling 4M White Confectionery Drop MB chocolate because it may contain undeclared peanut residue. Peanut allergen poses a risk to consumers with peanut allergies.

    Product
    4M White Confectionery Drop MB, Item # 56464. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Sugar, Palm Kernel Oil, Nonfat Dry Milk, Whole Milk Powder, Whey Powder (Milk) Palm Oil, Sunflower Lecithin (an emulsifier), Vanilla Extract. Distributed By: Clasen…
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-1258-2023·2023-03-22

    Dimension Tacrolimus Diagnostic Cartridge Recalled for Measurement Imprecision

    Siemens is recalling Dimension Tacrolimus diagnostic test cartridges (lots GA2286, GA3047, GA3171) due to confirmed measurement imprecision that could lead to incorrect drug dosing and potential organ failure or toxicity.

    Product
    Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension¿ clinical chemistry system SMN: 10700795 (DF207)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0429-2023·2023-03-22

    Milk Chocolate Wafers Recalled for Undeclared Peanut Residue

    Clasen Quality Chocolate is recalling milk chocolate confectionery wafers due to potential undeclared peanut residue. Consumers with peanut allergies should not consume this product.

    Product
    Milk Choc Flvd Confectionery Wafer (HP, NSA), Item # 52546. Net Wt. 40 lbs. (18.14 KG) poly-lined case. Ingredients: Palm Kernal Oil, Whey Protein Isolate, Erythritol, Sodium Caseinate, Cocoa Powder (Processed with Alkali), Natural Flavor, Sunflower Lecithin (an emulsifier)…
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-1257-2023·2023-03-22

    Beckman Coulter Access Immunoassay Analyzers Recalled for Defective Nut Bands

    Beckman Coulter is recalling approximately 4,100 laboratory immunoassay analyzers due to defective nut bands that may cause operational failures and erroneous patient test results.

    Product
    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2023·2023-03-22

    BD Ultra-Fine Insulin Syringe Recall Due to Nonsterile Manufacturing

    Becton Dickinson is recalling 45,000 units of BD Ultra-Fine Insulin Syringes (catalog 326679, lot 2164338) due to nonsterile manufacturing that could expose patients to pathogenic microorganisms and local infection. Distribution was worldwide.

    Product
    BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326679
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0621-2023·2023-03-22

    Frozen Wonton Wrappers Recalled Due to Peanut Contamination in Sub-Ingredient

    Bailey International Foods is recalling 4" x 4" and 3.5" x 3.5" frozen wonton wrappers due to peanut contamination in a sub-ingredient. The product was distributed to wholesalers in 19 states.

    Product
    Wonton wrappers, 4" x 4" and 3.5" x 3.5", packaged in 30lb. corrugated (cardboard) boxes. Product is sold frozen.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1248-2023·2023-03-22

    TFN Femoral Nails dimensions mislabeled, may measure 170mm or 200mm

    Synthes recalled TFN-Advanced Femoral Nails because some units have incorrect dimensions: nails labeled 200mm may measure 170mm, while those labeled 170mm may measure 200mm. This dimensional mismatch could compromise surgical fixation.

    Product
    TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0438-2023·2023-03-22

    Chocolate Baking Chips Recalled Due to Undeclared Peanut Residue

    Clasen Quality Chocolater has recalled 4M DF NSA Semisweet Baking Drop chocolate due to potential undeclared peanut residue. The product may pose a risk to consumers with peanut allergies.

    Product
    4M DF NSA Semisweet Baking Drop (FT), Item # 56854. Net Wt. 40 lbs. (18.14 KG) poly-lined case. Ingredients: Chocolate Liquor, Inulin, Erythritol, Cocoa Butter, Sunflower Lecithin (an emulsifier), Vanilla Extract, Stevia Leaf Reb M. Distributed By: Clasen Quality…
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-0618-2023·2023-03-22

    Spicy Kick snack mix recalled due to potential metal contamination

    Catalina Snacks is recalling Spicy Kick ready-to-eat snack mix pouches due to potential metal contamination. The product was distributed across multiple U.S. states and online sales.

    Product
    Spicy Kick flavored ready-to-eat snack mix packaged in 6oz (UPC 850017468153) plastic stand up pouch.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-0611-2023·2023-03-22

    Danone YoCrunch Vanilla Yogurt recalled for undeclared wheat allergen

    Danone US LLC is recalling YoCrunch Vanilla Lowfat Yogurt because the product contains undeclared wheat, which poses a risk to consumers with wheat allergies.

    Product
    YoCrunch Vanilla Lowfat Yogurt with M&Ms 6 oz (170g) UPC 046675000792 packaged in plastic cup with self-contained plastic dome attached on top, 12 cups per case
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0437-2023·2023-03-22

    Dark Chocolate Wafer Recalled for Undeclared Peanut Residue

    Clasen Quality Chocolater is recalling DF Dark Choc Flvd Wafer (Item #56810) in 50-pound cases because the product may contain undeclared peanut residue. Consumers with peanut allergies should not consume this product.

    Product
    DF Dark Choc Flvd Wafer (MB), Item # 56810. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Sugar, Palm Kernel Oil, Cocoa Powder (processed with Alkali), Sunflower Lecithin (an emulsifier), Salt. Distributed By: Clasen Quality Chocolate, 5126 West Terrace Drive…
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-0428-2023·2023-03-22

    White Confectionery Coating Wafer Recalled for Undeclared Peanut Residue

    Clasen Quality Chocolater is recalling 20,360 lbs of white confectionery coating wafer due to possible undeclared peanut residue that poses a risk to consumers with peanut allergies.

    Product
    White Confectionery Coating Wafer (HP, NSA), Item # 52544. Net Wt. 40 lbs. (18.14 KG) poly-lined case. Ingredients: Palm Kernal Oil, Whey Protein Isolate, Erythritol, Sodium Caseinate, Sunflower Lecithin (an emulsifier), Salt, and Sucralose. Distributed By: Clasen Quality…
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-0583-2023·2023-03-22

    Celestial Seasonings Mandarin Orange Spice Tea Contains Undeclared Caffeine

    Celestial Seasonings Mandarin Orange Spice herbal tea K-cups contain undeclared caffeine from black tea. The recall affects 1,844 units distributed nationwide.

    Product
    Celestial Seasonings Mandarin Orange Spice Herbal Tea in K-cup pods; packed 24 to a box
    Category
    Food
    Distribution
    42 states
  • HighFDA (Devices)·Z-1249-2023·2023-03-22

    Plato 17 Microcatheter Recalled Due to Loose Particle Risk

    Scientia Vascular is recalling Plato 17 Microcatheters due to manufacturing defects that may introduce loose particles into the catheter lumen, potentially causing blood vessel blockage or inflammatory reactions.

    Product
    Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1255-2023·2023-03-22

    Medical Device Apheresis Kit Recalled Due to Stress Leak Risk

    Fenwal Inc is recalling 6,564 units in certain lots of Amicus apheresis kits because centrifuge packs may develop a stress leak. No illnesses or injuries have been reported.

    Product
    Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1250-2023·2023-03-22

    Arial mobile application recalled for Android loading failures

    Securitas Healthcare is recalling the Arial mobile application for Android devices because the app does not load or function properly. Users should stop using the app immediately.

    Product
    Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Play Store as part of the Arial Emergency and Nurse Call system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0613-2023·2023-03-22

    Chocolate Peanut Butter cereal recalled due to metal contamination

    Catalina Snacks is recalling Chocolate Peanut Butter cereal (9oz pouches) due to metal contamination. The recall affects approximately 316,980 pouches distributed across multiple states and online retailers.

    Product
    Chocolate Peanut Butter flavored ready-to-eat cereal packaged in 9oz (UPC 850017468184) plastic stand up pouch.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-0422-2023·2023-03-22

    Sheetz Ham Deli Sandwiches Recalled for Undeclared Sesame

    Sheetz is recalling M.T.go! Ham Deli Sandwiches that may contain undeclared sesame, a common allergen. The recall affects 5,715 sandwiches in PA, MD, OH, WV, NC, and VA.

    Product
    Sheetz M.T.go!, Made To Go Ham Deli Sandwich. The products are packaged in 4.75 oz. clear, plastic clamshells with the following UPC 759465001847 (Ham).
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0436-2023·2023-03-22

    Chocolate Confectionery Drops Recalled Due to Undeclared Peanut Residue

    Clasen Quality Chocolater is recalling 4M Cinnamon Flvd Confectionery Drops because the chocolate may contain undeclared peanut residue. Consumers with peanut allergies should not consume this product.

    Product
    4M Cinnamon Flvd Confectionery Drop (MB), Item # 56466. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Sugar, Palm Kernel Oil, Nonfat Dry Milk, Ground Cinnamon, Sunflower Lecithin (an emulsifier). Distributed By: Clasen Quality Chocolate, 5126 West Terrace…
    Category
    Food
    Distribution
    12 states