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.

10476–10500 of 88183

  • ModerateFDA (Drugs)·D-0046-2025·2024-11-20

    Perio Maintenance Rinse Recalled for Subpotent Stannous Fluoride Concentration

    Keystone Industries is recalling Perio Maintenance Rinse due to subpotency—the stannous fluoride concentration is below specifications. Affected lots were distributed nationwide.

    Product
    Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flavor, Manufactured by: Keystone Industries, 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC 68400-202-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0460-2025·2024-11-20

    FDA Recalls MEERA CL Mobile Operating Tables for Unintended Movement Stops

    Getinge Usa Sales Inc is recalling 112 MEERA CL mobile operating tables because error code 50037 may cause the table to stop moving unexpectedly when controlled via IR hand control, resulting in procedural delays.

    Product
    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0350-2025·2024-11-20

    Medline arthroscopy surgical kits recalled for incomplete packaging seal

    Medline Industries is recalling 80 arthroscopy surgical convenience kits due to incomplete packaging seals. The affected lot numbers are 24GBI464 and 24HBO800.

    Product
    ARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0104-2025·2024-11-13

    Aunt Millie's Bakehouse Hot Dog Buns Recalled for Undeclared Sesame Allergen

    Perfection Bakeries LLC is recalling Aunt Millie's Bakehouse Whole Grain White Hot Dog Buns for containing undeclared sesame. Approximately 10,987 cases distributed across multiple states.

    Product
    Aunt Millie s Bakehouse Whole Grain White Hot Dog Buns 6" Sliced 2 OUNCE. 12 unlabeled 12CT PKGS per sale unit case, product code 7502. Net. Wt. 18lbs.
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Food)·F-0102-2025·2024-11-13

    Aunt Millie's Whole Grain Dinner Rolls Recalled for Undeclared Sesame

    Perfection Bakeries LLC is recalling 1,144 cases of Aunt Millie's Bakehouse Whole Grain Dinner Rolls due to undeclared sesame. The product was distributed in 12 states. Consumers with sesame allergies should not consume this product.

    Product
    Aunt Millie s Bakehouse Whole Grain Dinner Rolls 2.5" Sliced 1.34 OUNCE. 8 unlabeled 24CT PKGS per sale unit case, product code 7488. Net. Wt. 16lbs.
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Devices)·Z-0227-2025·2024-11-13

    Elekta Disposable Biopsy Needles Recalled for Internal Debris Contamination

    Elekta recalls disposable biopsy needles for the Leksell Stereotactic System due to microscopic stainless steel debris found inside the needles. 111 kits (666 needles) distributed across multiple U.S. states are affected.

    Product
    Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF…
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Food)·F-0105-2025·2024-11-13

    Gordon Food Service Hawaiian Rolls Recalled for Undeclared Sesame

    Perfection Bakeries is recalling Gordon Food Service Hawaiian Pull-Apart Dinner Rolls due to undeclared sesame. The recall affects 61,658 cases distributed across 12 states; consumers with sesame allergies should not consume the product.

    Product
    Gordon Food Service Hawaiian Pull-Apart Dinner Rolls Unsliced 1.25 Ounce. 10 unlabeled 12CT PKGS per sale unit case, product code 7148. Net. Wt. 9lbs. 6oz.
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Food)·F-0101-2025·2024-11-13

    Bread Recall: Undeclared Sesame Allergen in Aunt Millie's Bakehouse

    Perfection Bakeries LLC is recalling Aunt Millie's Bakehouse 100% Whole Wheat Pullman Bread due to undeclared sesame. Affected product was distributed across twelve U.S. states.

    Product
    Aunt Millie s Bakehouse 100% Whole Wheat Pullman Bread 1/2" Sliced 22 OUNCE loaf. 12 unlabeled loaves per sale unit case, product code 9520, Net Wt. 16lbs. 8oz.
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Food)·F-0103-2025·2024-11-13

    Bakery Bread Recall: Undeclared Sesame Allergen in Aunt Millie's Texas Toast

    Perfection Bakeries is recalling Aunt Millie's Bakehouse Texas Toast due to undeclared sesame, which poses a serious risk to consumers with sesame allergies. Approximately 1,500 cases were distributed across multiple states.

    Product
    Aunt Millie s Bakehouse Texas Toast 3/4" Sliced 22 OUNCE loaf. 12 unlabeled loaves per sale unit case, product code 9519. Net. Wt. 16lbs 8oz.
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-0040-2025·2024-11-13

    Ascorbic Acid Injection Recalled Nationwide for Glass Contamination

    Staska Pharmaceuticals recalled ascorbic acid injectable solution due to glass contamination. The FDA classified the recall as Class I; 4,773 vials nationwide were affected.

    Product
    Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0100-2025·2024-11-13

    Bread Recall: Undeclared Sesame in Aunt Millie's Bakehouse White Pullman

    Perfection Bakeries recalls Aunt Millie's Bakehouse White Pullman Bread (22 oz) due to undeclared sesame. The recall affects 7,092 cases distributed across multiple states.

    Product
    Aunt Millie s Bakehouse White Pullman Bread 1/2" Sliced 22 OUNCE. 12 unlabeled 22 OUNCE LOAVES per sale unit case, product code 9518. Net Wt. 16lb 8oz.
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Food)·F-0099-2025·2024-11-13

    Aunt Millie's Bakehouse Hawaiian Hamburger Buns Recalled for Undeclared Sesame

    Aunt Millie's Bakehouse Hawaiian Hamburger Buns contain undeclared sesame and are being recalled by Perfection Bakeries LLC. The Class I recall affects 6,400 cases distributed across 12 states.

    Product
    Aunt Millie s Bakehouse Hawaiian Hamburger Buns 4.5" Sliced 3 OUNCE. 6 unlabeled 12CT PKGS per sale unit case, product code 7430. Net Wt. 13lb 8oz.
    Category
    Food
    Distribution
    12 states
  • HighFDA (Drugs)·D-0036-2025·2024-11-13

    Morphine Sulfate Extended-Release Tablets Recalled for Impurities and Degradation

    Dr. Reddy's Laboratories is recalling Morphine Sulfate Extended-Release Tablets 15 mg nationwide due to failed impurity and degradation specifications. Patients taking affected lots should contact their healthcare provider immediately.

    Product
    Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0324-2025·2024-11-13

    Hillrom Diagnostic Cardiology Suite Software Duplicate UID Assignment Recall

    Hillrom diagnostic cardiology spirometer software may incorrectly assign duplicate identifiers to exam files, risking patient data mismatches. 1,369 units affected worldwide.

    Product
    Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0319-2025·2024-11-13

    Coated VICRYL Surgical Sutures Recalled for Needle Pull-Off and Degradation

    Ethicon is recalling Coated VICRYL surgical sutures due to needle pull-off and visual degradation. Lot QP2AJM, consisting of 31,032 units, was distributed to China.

    Product
    Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0309-2025·2024-11-13

    DeRoyal Surgical Procedure Pack Smoke Evacuation Pencil Recalled

    DeRoyal is recalling surgical procedure pack products containing a Stryker SafeAir Smoke Evacuation Pencil that may activate without manual input or remain active after buttons are released. The malfunction poses a risk of injury during surgical procedures.

    Product
    DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0286-2025·2024-11-13

    epoc BGEM BUN Test Cards recalled for sodium measurement bias

    Siemens recalled epoc BGEM BUN Test Cards for a negative sodium bias occurring approximately 2 months before expiration, with maximum observed bias of -10 mmol/L. No adverse events reported.

    Product
    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0313-2025·2024-11-13

    Beckman Coulter Access Cortisol Assay Recalled for Calibration Error

    Beckman Coulter is recalling 149 units of the Access Cortisol assay due to an incorrect calibration curve parameter that may cause test delays and potential injuries.

    Product
    The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0318-2025·2024-11-13

    GE Healthcare Centricity Viewer Security Vulnerability Could Allow Unauthorized Access

    GE Healthcare's Centricity Universal Viewer Zero Footprint medical imaging software contains a security vulnerability that could allow unauthorized access and patient data manipulation. Approximately 120 units are affected worldwide.

    Product
    GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2089507-093, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02268286, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02030900…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0325-2025·2024-11-13

    Cardiac stress testing system may assign duplicate exam identifiers to patients

    Hillrom Welch Allyn XScribe cardiac stress testing systems may assign duplicate exam identifiers, potentially causing patient data mismatches in medical record systems.

    Product
    Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0035-2025·2024-11-13

    Timolol Maleate Eye Drops Recalled Due to Defective Container

    FDC Limited is recalling 155,232 bottles of Timolol Maleate Ophthalmic Solution due to a defective cap spike that becomes lodged in the nozzle, preventing medication dispensing.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0323-2025·2024-11-13

    Electrocardiograph DICOM Files Risk Patient Data Mismatch Due to Duplicate Identifiers

    Certain Hillrom Welch Allyn Vision Express Holter Analysis Systems may assign duplicate identifiers to cardiac exam files, risking mismatch between patient identities and their physiological data.

    Product
    Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0097-2025·2024-11-13

    EM Tortillas Mexican sweet bread recalled for undeclared allergens

    EM Tortillas, LLC is recalling bulk Mexican sweet bread varieties due to undeclared wheat, soy, and egg allergens. Products are packaged in unlabeled poly bags and distributed in California.

    Product
    Bulk Mexican sweet bread varieties including conchas, fino ellotes, fino curenos, danes ellotes, danes cuernos, bolillos, and teleras. Bakery products are packaged in unlabeled poly bags.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0289-2025·2024-11-13

    Medtronic DLP Aortic Root Cannula Recalled for Potential Sterility Breach

    Medtronic is recalling 420 units of DLP Aortic Root Cannulas due to a potential sterility breach caused by a misaligned seal.

    Product
    Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0287-2025·2024-11-13

    Surgical neurological sponges recalled for detaching X-ray markers

    American Surgical Company is recalling 390 units of Americot 20-01S neurological sponges used in surgery. The X-ray detectable barium strip may detach, potentially delaying the surgical process.

    Product
    Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/A
    Category
    Medical Device
    Distribution
    8 states