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.

9251–9275 of 27089

  • HighFDA (Devices)·Z-3216-2024·2024-10-02

    ACUSON Redwood Ultrasound Systems Recall for Software Unit Conversion Error

    Siemens ACUSON Redwood ultrasound systems may display measurements 10 times smaller than actual if operators change the software from factory defaults to milliliters per second or minute. This could lead to misdiagnosis and poor patient management.

    Product
    ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3198-2024·2024-10-02

    Philips Ingenia Ambition X MRI Scanner Recalled Due to Loose Screws

    Philips is recalling 63 units of the Ingenia Ambition X MRI scanner due to loose screws in the IRF carrier assembly that may block the imaging tabletop and potentially delay diagnosis.

    Product
    Ingenia Ambition X - 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: 782109
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3210-2024·2024-10-02

    AVS Anchor-C Cervical Cage Instructions for Use Labeling Correction

    Stryker Spine recalled the electronic Instructions for Use revision 5 for the AVS Anchor-C Cervical Cage System because specific indications language for the US and Canada was inadvertently removed.

    Product
    AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3225-2024·2024-10-02

    Karl Storz Nephroscope Recall Due to Unapproved Reprocessing Instructions

    Karl Storz Endoscope nephroscopes (REF: 27840KA) are being recalled because their instructions for use contain reprocessing methods that have not been reviewed or approved by the FDA for safety and efficacy.

    Product
    Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123
    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-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-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 (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 (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
    0 states
  • 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 (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-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-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
    0 states
  • 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
    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
    0 states
  • 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
    0 states
  • 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 (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 (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 (Devices)·Z-3181-2024·2024-09-25

    HAWK Warming Grid recalled for incorrect expiration date

    Safeguard US Operating LLC is recalling the HAWK Warming Grid (Item 59-300) due to an incorrect expiration date. The affected units may not function safely if used beyond the actual expiration date.

    Product
    HAWK Warming Grid, Item Number: 59-300
    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 (Devices)·Z-3144-2024·2024-09-25

    Anesthesia Extension Sets recalled due to potential Spin Lock connector leakage

    B. Braun Medical is recalling 19,050 AET36 Anesthesia Extension Sets due to potential product leakage from the Spin Lock Connector caused by excess solvent migration during manufacturing.

    Product
    AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3151-2024·2024-09-25

    Boston Scientific VTC Nephrostomy Catheter Kit Recalled for Sterile Barrier Defect

    Boston Scientific is recalling VTC Regular Kit Nephrostomy Catheter System kits due to potential holes in the sterile barrier of the device pouch, which may compromise device sterility.

    Product
    VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3180-2024·2024-09-25

    Beckman Coulter Analyzer Recalled for Pneumatic Tubing Defects

    Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized pneumatic tubing in the reagent storage module, which can cause air leaks and compressor failures, potentially leading to test errors and delayed results.

    Product
    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide