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.

19276–19300 of 88183

  • ModerateFDA (Devices)·Z-1391-2023·2023-04-26

    KLS E-Coupling Adapter Recalled for Incorrect Product Identifier Code

    Pro-Dex Inc is recalling 199 KLS E-Coupling Adapter devices due to incorrect Unique Device Identifier (UDI) and GTIN codes. The devices were distributed nationwide.

    Product
    KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1406-2023·2023-04-26

    Avanos Ballard Oral Care Swabs recalled for incorrect expiration date labeling

    Avanos Medical is recalling Ballard Oral Care Swabs (codes 12241, 12243, 12251) due to incorrect expiration date labeling. The recall affects 5,475 cases distributed worldwide.

    Product
    Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1396-2023·2023-04-26

    VITROS COVID-19 Antibody Test Calibrators Recalled for Incorrect Calibrator Levels

    Ortho-Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Total N Antibody Calibrators used in COVID-19 testing due to incorrect calibrator levels in Assay Data Disks, which can delay patient test results.

    Product
    VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code: 6199976
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0537-2023·2023-04-26

    CVS Earwax Removal Drops Recalled for Subpotent Active Ingredient

    CVS-distributed earwax removal drops containing carbamide peroxide are being recalled because the active ingredient may degrade and become subpotent before the labeled expiration date, potentially leaving the product ineffective.

    Product
    Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, CVS Product # 999532, UPC 0 50428 36475 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0747-2023·2023-04-26

    Natural Pak Coffee Chili Rub Contains Undeclared Bacon Glaze Ingredients

    Natural Pak brand Coffee Chili Rub packages contain undeclared Bacon Glaze ingredients including demerara sugar, honey granules, maple sugar, cinnamon, allspice, clove, and parsley. The affected product was distributed in Ohio.

    Product
    Natural Pak brand Coffee Chili Rub is packaged in 22oz (624g), white, cylindrical, plastic containers; Ingredients: Sea salt, ancho chile, brown sugar, espresso beans, hot smoked paprika, mustard, black pepper, coriander, ginger, oregano, chipotle chile, paprika. Contains…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1408-2023·2023-04-26

    Medtronic SenSight Extension Tunneler Kit: manufacturing defect prevents dual-extension passage

    Medtronic recalled approximately 1414 SenSight Extension Tunneler Kits due to a manufacturing defect where dual carriers were machined on only one side, preventing use for passing two extensions simultaneously.

    Product
    Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1398-2023·2023-04-26

    Pressure Therapy System Recalled for Unauthorized Deep Vein Thrombosis Prevention Claim

    Compass Health Brands is recalling the REX Pressure Therapy System because the user manual incorrectly claims the device can prevent deep vein thrombosis, an indication for which the device was not FDA-cleared.

    Product
    REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and DVTREX -L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0705-2023·2023-04-19

    Frozen Organic Strawberries Recalled Due to Hepatitis A Contamination

    Multiple brands of frozen organic strawberries are being recalled due to potential hepatitis A contamination. The recall affects products distributed across the United States.

    Product
    Simply Nature Organic Strawberries, frozen, net wt. 24 oz., 8 packages per case. UPC 4099100256222. Product of Mexico. Distributed by Aldi Batavia, IL Vital Choice Organic Strawberries, frozen, net wt. 16 oz., 20 packages per case. UPC 834297005024. Product of Mexico.…
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0702-2023·2023-04-19

    Organic Strawberries Recalled Due to Hepatitis A Contamination Risk

    California Splendor, Inc. is recalling 30-pound cases of Organic IQF Whole Strawberries due to potential Hepatitis A contamination. The recall affects 202,500 pounds distributed to Oregon and California.

    Product
    30 lb. cases of Organic IQF Whole Strawberries
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0742-2023·2023-04-19

    Kagome Worcester Sauce Recalled Due to Undeclared Soy Allergen

    Mutual Trading Company Inc. is recalling Kagome Worcester Sauce (Lot 2024.5.26 or before) because it contains soy that is not declared on the label. Consumers with soy allergies may face serious health risks.

    Product
    Kagome Worcester Sauce 6/60 fl oz. Ingredients: Water, Sugar, Salt, Fermented Vinegar, Glucose, Tomato Extract, Caramel Coloring, Protein Hydrolysate, Onion Extract, Garlic Extract, Thickener (Guar Gum), Spice, Onion Concentrate, Licorice, Spice Extract, Chili Pepper Extract…
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0708-2023·2023-04-19

    Biltmore Smoked Sockeye Salmon Recalled for Potential Listeria Contamination

    Seven Seas International USA LLC is recalling Biltmore Smoked Sockeye Salmon 4 oz packages due to potential Listeria monocytogenes contamination. Lot R4058 with expiration 03-31-2024 is affected.

    Product
    Biltmore Smoked Sockeye Salmon - 4 oz
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0701-2023·2023-04-19

    Organic Sliced Strawberries Recalled for Potential Hepatitis A Contamination

    California Splendor, Inc. is recalling 400-lb. drums of 39+1 Organic Sliced Strawberries Refrigerated due to potential Hepatitis A contamination. Product distributed to Oregon and California; consumers should not consume.

    Product
    400-lb. drums of 39+1 Organic Sliced Strawberries Refrigerated
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0744-2023·2023-04-19

    Kagome Tonkatsu Sauce Recalled Due to Undeclared Soy Allergen

    Mutual Trading Company Inc. is recalling Kagome Take Out Tonkatsu Sauce (STOCK #24274) because it contains an undeclared soy allergen. The recall affects 393 cases distributed to CA, AZ, NZ, TX, NM, OK, and HI.

    Product
    Kagome Take Out Tonkatsu Sauce STOCK: #24274 40 packets (8g) in a plastic bag. 15 bags in a box
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0703-2023·2023-04-19

    Frozen Organic Strawberries Recalled for Potential Hepatitis A Contamination

    Frozen Organic Strawberries sold under multiple brands (Kirkland Signature, Trader Joe's, and others) are being recalled due to potential hepatitis A contamination. Do not consume; discard or return to retailer.

    Product
    Frozen Organic Strawberries, Kirkland Signature, frozen, net wt. 4lb., 9 packages per case, Costco Item 904984. UPC 096619140404. Distributed by Costco Warehouse Corporation, Seattle, WA. Product of Mexico.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0704-2023·2023-04-19

    Trader Joe's Frozen Tropical Fruit Blend Recalled for Hepatitis A Risk

    Scenic Fruit Company is recalling Trader Joe's Organic Tropical Fruit Blend and related products distributed nationwide and regionally due to potential Hepatitis A contamination from Mexican strawberries. Five lot numbers with Best By dates from April to June 2024 are affected.

    Product
    Trader Joes Organic Tropical Fruit Blend, frozen, net wt. 16 oz., 24 bags per case, SKU 051191. UPC 00511919. This product contains strawberries from Mexico. Distributed by Trader Joe's Monrovia, CA.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1313-2023·2023-04-19

    Ivenix Large Volume Infusion Pump Recalled Due to Fluid Ingress Risk

    Fresenius Kabi is recalling the Ivenix Infusion System Large Volume Pump (Model LVP-0004) because fluid ingress can damage the device, causing loss of electrical function and preventing or halting infusion.

    Product
    Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Food)·F-0743-2023·2023-04-19

    Kagome Chuno Sauce Recalled for Undeclared Soy Allergen

    Mutual Trading Company is recalling Kagome Chuno Sauce (10 fl oz bottles, 51 cases) distributed to select U.S. states due to undeclared soy allergen, which poses serious health risks for allergic consumers.

    Product
    Kagome Chuno Sauce 30/10 fl oz Stock#24269 Ingredients: Tomato, Apple, Carrot, Brewed Vinegar, Sugar, Glucose, Salk, L-Glutamic Acid, Spice, Corn Starch, Fermented Seasoning, Xanthan Gum, Licorice. Imported By Mutual Trading Co., Inc. El Monte, CA 91731 North American Food…
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1350-2023·2023-04-19

    First Response Easy Read App unable to reliably read pregnancy test results

    Church & Dwight's Easy Read App for pregnancy test sticks may fail to display test results or misread them, leading to false positive or false negative results. The app was marketed without required FDA clearance.

    Product
    Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e.g., smart phone, iPad)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1363-2023·2023-04-19

    Inflatable Penile Prosthesis Risk of Premature Pump Failure

    Coloplast's Titan Touch NB Scrot Zero 16cm prosthesis has been recalled due to decreased wall thickness that could cause premature pump failure. The defect was identified in specific lot units distributed worldwide.

    Product
    Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1386-2023·2023-04-19

    Stryker MAKO RESTORIS tibial baseplate trial recalled for incorrect size marking

    Stryker is recalling 102 units of MAKO RESTORIS MultiCompartmental Knee tibial baseplate trials with incorrect size laser markings. Wrong markings could lead to selection of incorrect implant sizes during partial knee replacement surgery.

    Product
    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1385-2023·2023-04-19

    Knee implant trial components recalled for incorrect size laser markings

    Stryker MAKO RESTORIS MCK tibial baseplate trial components used in knee surgery contain incorrect laser markings indicating component size. This affects 52 units distributed internationally and could lead to implantation of wrong-sized components during surgery.

    Product
    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0707-2023·2023-04-19

    Impossible Chicken Nuggets Recalled for Possible Wood Fragments

    Impossible Foods Inc is recalling 128,029 cases of Impossible Chicken Nuggets nationwide due to possible wood fragments in the product, which pose a choking and injury risk.

    Product
    Impossible Chicken Nuggets Made From Plants, 2x5 lb Bags. Item No. 60-00031. Net Wt.: 10 lb (4.5kg). Not for retail sale. Fully Cooked. Perishable, Keep Frozen. Distributed by: Impossible Foods, Inc., Redwood City, CA 94063.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1384-2023·2023-04-19

    Knee Patella Drills Recalled for Incorrect Diameter Markings

    Encore Medical is recalling EMPOWR Knee Patella drills due to reversed diameter markings that could cause incorrect drill selection during surgery, leading to implant loosening or bone fracture.

    Product
    EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
    Category
    Medical Device
    Distribution
    8 states