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.

11101–11125 of 88183

  • ModerateFDA (Devices)·Z-3196-2024·2024-10-02

    Philips Ingenia 3.0T CX MRI Machine Carrier Assembly Screws May Loosen

    Philips Ingenia 3.0T CX MRI machines may have loose screws in the RF carrier assembly that could protrude and interfere with the tabletop mechanism, potentially delaying patient scans.

    Product
    Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782105
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3254-2024·2024-10-02

    Cook Biotech Recalls Biodesign Fistula Plug Due to Early Expiration

    Cook Biotech, Inc. is recalling 102 units of Biodesign Fistula Plug C-FPS-0.7 because the products expire prior to the date printed on the labeling.

    Product
    Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54614
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3189-2024·2024-10-02

    Stainless Steel Sims Uterine Sound Recalled for Incorrect Part Number

    CooperSurgical, Inc. is recalling the Stainless Steel Sims Uterine Sound (Part Number 64-601) because some units were laser-marked with incorrect part numbers during manufacturing. No injuries have been reported.

    Product
    Stainless Steel Sims Uterine Sound, Part Number 64-601
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3214-2024·2024-10-02

    GE Centricity PACS Image Storage Failure When Maximum Identifiers Reached

    GE Healthcare Centricity PACS versions V2-V7 may fail to store medical images when reaching maximum unique image identifiers, potentially resulting in incomplete imaging studies. No injuries have been reported.

    Product
    GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3188-2024·2024-10-02

    CooperSurgical Recalls Silver-Plated Copper Sims Uterine Sound for Incorrect Marking

    CooperSurgical is recalling 468 units of Silver-Plated Copper Sims Uterine Sounds because they were laser-marked with the incorrect part number during manufacturing.

    Product
    Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3253-2024·2024-10-02

    Cook Biotech Recalls Biodesign Fistula Plugs Due to Expiration Date Errors

    Cook Biotech is recalling 93 Biodesign Fistula Plugs because the products expire prior to the expiration date printed on the labeling.

    Product
    Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54613
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3220-2024·2024-10-02

    Karl Storz Hopkins Telescope 6 endoscope recalled for unapproved reprocessing instructions

    Karl Storz is recalling the Hopkins Telescope 6 endoscope because its Instructions for Use contain reprocessing procedures that have not been FDA-reviewed or approved. The recall affects 1,982 units distributed nationwide.

    Product
    Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0662-2024·2024-10-02

    Sunscreen product recalled for microbial contamination nationwide

    SHEET SPF 30 Mineral sunscreen is being recalled for microbial contamination. The product was distributed nationwide.

    Product
    SHEET SPF 30 MINERAL — SHEET SPF 30 MINERAL (TITANIUM DIOXIDE, ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0667-2024·2024-10-02

    Hand Sanitizer Manufacturer Recalls Product for Manufacturing Deviations

    EnviroServe Chemicals Inc. is recalling EnviroClean Hand Sanitizer Gel due to manufacturing deviations. The voluntary recall affects 120 bottles distributed to one North Carolina distributor.

    Product
    EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-3261-2024·2024-10-02

    Biodesign Inguinal Hernia Graft Recall Due to Premature Expiration

    Cook Biotech is recalling Biodesign Inguinal Hernia Graft units because products expire before their labeled expiration date, potentially affecting surgical outcomes.

    Product
    Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-3084-2024·2024-09-25

    Baxter pharmaceutical compounding inlets recalled for particulate matter contamination

    Baxter is recalling EXACTAMIX compounding device inlets due to particulate matter observed in sterile fluid pathways before use. Approximately 5.8 million units affected worldwide.

    Product
    Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1815-2024·2024-09-25

    Supreme Peppers Products Recalled for Possible Listeria Contamination

    GBC Food Services, LLC is recalling multiple Supreme Peppers products distributed in Indiana due to possible contamination with Listeria Monocytogenes. Consumers should not consume these products.

    Product
    Supreme Peppers Tri Blend 8-50053-68534 8 OZ Supreme Jalapenos Diced 8-50053-68536 7 OZ Supreme Peppers W/Onions 8-50053-68538 7 OZ Supreme Peppers Snacking 8-50053-68553 12 OZ
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1816-2024·2024-09-25

    Supreme Guacamole and Pico Products Recalled for Possible Listeria Contamination

    GBC Food Services is recalling Supreme brand guacamole and pico/guacamole products distributed in Indiana due to possible contamination with Listeria monocytogenes.

    Product
    Supreme Guacamole Chunky Mild 8-50053-68588 17 OZ Supreme Guacamole Chunky Medium 8-50053-68589 17 OZ Supreme Pico/Guacamole 8-50054-89443 16 OZ Supreme Pico/Guacamole
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-3082-2024·2024-09-25

    Baxter EXACTAMIX Inlet Compounders Recalled for Particulate Matter Contamination

    Baxter Healthcare is recalling EXACTAMIX Inlet components (H938173 and related codes) due to particulate matter contamination observed in the sterile fluid path before use. Approximately 3.58 million units distributed worldwide are affected.

    Product
    Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1818-2024·2024-09-25

    Marabou Sea Salt Chocolate Bars Recalled for Undeclared Allergens

    BonBon NYC LLC is recalling Marabou Sea Salt Chocolate Bars due to undeclared almonds, wheat, and tree nuts. Consumers allergic to these ingredients should not consume the product.

    Product
    Marabou Sea Salt Chocolate Bar; 185g; yellow plastic packaging and the word 'havvsalt', the Swedish word for "sea salt"; product is a flat chocolate bar
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-3083-2024·2024-09-25

    Baxter EXACTAMIX pharmaceutical compounding inlets recalled for particulate contamination

    Baxter Healthcare Corporation is recalling EXACTAMIX Inlet components due to particulate matter found in sterile fluid path tubing. Approximately 1.5 million units were distributed worldwide.

    Product
    Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1809-2024·2024-09-25

    Bliss Tree Millet Butter Murukku Recalled for Undeclared Sesame and Milk Allergens

    Bliss Tree Millet Butter Murukku products are being recalled due to undeclared sesame and milk allergens. Affected products were distributed to retailers and online customers in multiple states.

    Product
    Bliss Tree Millet Butter Murukku 200g UPC:8906087451631. Packaged in box, 13 boxes per cases. Bliss Tree Millet Butter Murukku 400g UPC:8906087452850. Packaged in pouches, 8 pouches per cases.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1817-2024·2024-09-25

    Supreme Vegetables Recalled Due to Possible Listeria Contamination

    Yummi Sushi is recalling Supreme vegetable products distributed in Indiana due to possible Listeria monocytogenes contamination. Consumers should not consume these products.

    Product
    Supreme Grilling Veggies 8-50053-68584 19 OZ Supreme Vegetable Kabobs 8-50053-68585 27 OZ Supreme Vegetable Bowl 8-60010-50713 26 OZ
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-3085-2024·2024-09-25

    Baxter ExactaMix Inlets Recalled for Particulate Contamination Risk

    Baxter Healthcare is recalling ExactaMix pharmaceutical compounding device inlets due to increased reports of particulate matter in the sterile fluid path before use. The recall involves 2,140,046 units with worldwide distribution.

    Product
    Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1814-2024·2024-09-25

    Kodiak Protein-Packed Power Waffles Recalled for Plastic Film Contamination

    Kodiak Cakes LLC is recalling 7,300 boxes of Kodiak Protein-Packed Power Waffles due to soft plastic film contamination. Consumers should not consume the affected product.

    Product
    KODIAK PROTEIN-PACKED POWER WAFFLES BUTTERMILK & VANILLA NET WT 3.35 lb (53.6oz) 1.52kgCreated & distributed by: KODIAK CAKES PARK CITY, UT 84098 UPC 7 05599 01920 3
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-3165-2024·2024-09-25

    Philips Azurion X-ray Systems: Cable Hose Carrier Detachment Risk

    Philips recalls Azurion X-ray imaging systems due to potential cable hose carrier detachment from broken plastic or bolts, which may cause parts to fall and create injury risk.

    Product
    System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion 7 M12 722228 Azurion 5 M20 722227 Azurion 5 M12 722226 Azurion 7 B20 722225 Azurion 7 B12 722224 Azurion 7 M20 722223 Azurion 7 M12 722222…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3171-2024·2024-09-25

    K-Wire Packaging Error Recall by Smith & Nephew

    Smith & Nephew issued a voluntary recall of K-Wire bone fixation fasteners due to a packaging error where packages contained the wrong wire diameter than labeled.

    Product
    DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1819-2024·2024-09-25

    Wegmans Pecan Blend Recalled Due to Undeclared Almonds

    Flagstone Foods LLC is recalling Wegmans Pecan Blend because it contains undeclared almonds, a common allergen. The product was distributed to nine states: DC, DE, MA, MD, NC, NJ, NY, PA, and VA.

    Product
    Wegmans PECAN BLEND NET WT 16OZ (1LB) 453g Ingredients: Pecans, Cashews, Pistachios, Canola and/or Peanut and/or Cottonseed Oil, Salt. Distributed By: Wegmans Food Markets, Inc. Rochester, NY 14603 UPC 0 77890 31040 3
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-3147-2024·2024-09-25

    Boston Scientific Recalls Flexima APDL Drainage Catheter Systems Due to Sterility Risk

    Boston Scientific is recalling 89 units of Flexima APDL Drainage Catheter Systems because holes in the sterile barrier may compromise device sterility.

    Product
    Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3178-2024·2024-09-25

    Streamline Bloodline Hemodialysis Sets Recalled for Patient Connector Defect

    B. Braun is recalling 9,864,165 Streamline Bloodline Sets nationwide due to incomplete patient connector insertion. The defect may restrict fluid flow during hemodialysis and cause therapy delays.

    Product
    STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096
    Category
    Medical Device
    Distribution
    Distributed nationwide