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.

8226–8250 of 27089

  • HighFDA (Devices)·Z-0610-2025·2024-12-11

    GE Healthcare Revolution Maxima CT Systems Recalled for Progressive Image Rotation

    GE Healthcare recalled Revolution Maxima and related CT imaging systems that can produce progressively rotated images during helical, cine, and cardiac scans. Approximately 72 units worldwide are affected; no patient injuries reported.

    Product
    GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0640-2025·2024-12-11

    MEDLINE convenience kits recalled due to defective component

    Medline is recalling multiple lots of its convenience kits because they contain a component (SafeAir Smoke Evacuation Pencil) that was previously recalled by Stryker. The affected kits are distributed nationwide.

    Product
    MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780202R; 4) ACDF CDS, REF CDS941061M; 5) NEURO KIT, REF CDS981327Q; 6) ZALE V-P SHUNT CDS, REF CDS983186J; 7) NEURO PACK-LF, R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0237-2025·2024-12-11

    Sysco Low Cal Lemonade Recalled for Metal Fragments

    DYMA Brands is recalling Sysco Low Cal Lemonade (8.6 oz pouches) due to metal fragments introduced during production. The product was distributed across 29 states.

    Product
    SYSCO LOW CAL LEMONADE, NET WT. 8.6OZ, Case UPC 00734730132648, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
    Category
    Food
    Distribution
    30 states
  • HighFDA (Drugs)·D-0107-2025·2024-12-11

    Duloxetine DR Capsules recalled nationwide for nitrosamine impurity

    Rising Pharmaceuticals is recalling Duloxetine DR Capsules 60 mg nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA interim limits. The recall affects approximately 233,003 bottles.

    Product
    Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0649-2025·2024-12-11

    Medline recalls surgical kits containing Stryker smoke evacuation pencil component

    Medline is recalling medical convenience kits containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 3) BASIC BACK CDS, REF CDS780147N; 4) INSTRUMENTED BACK CDS, REF CDS780148Q; 5) INSTRUMENTED BACK CDS, REF CDS780148R; 6) TOTAL HIP, REF CDS920027W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0106-2025·2024-12-11

    Duloxetine Delayed-Release Capsules Recalled for N-Nitroso Impurity Above Limits

    Rising Pharma is recalling 122,925 bottles of Duloxetine 30 mg capsules nationwide due to a manufacturing deviation: the presence of N-nitroso-duloxetine impurity above the recommended interim limit.

    Product
    Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0098-2025·2024-12-11

    Diltiazem Hydrochloride Capsules Recalled Due to Nitrosamine Impurity

    Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride capsules because they contain a chemical impurity above safe limits. About 7,296 bottles were distributed nationwide.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0247-2025·2024-12-11

    Ready-meal chicken tacos recalled due to Listeria monocytogenes

    Albertsons ready-meal chicken street taco kits have been recalled due to potential Listeria monocytogenes contamination in the cooked chicken. The recall affects 2,374 units distributed across 21 U.S. states.

    Product
    (1) READY MEALS CHICKEN STREET TACOS SS COLD (UPC 27131600000) (2) READY MEALS ASADA STREET TACO MEAL SS COLD (UPC 29939100000) (3) READY MEALS CHICKEN STREET TACO MEAL SM SS COLD (UPC 27179600000)
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-0615-2025·2024-12-11

    GE Healthcare CT Operator Console Update: Images May Rotate Progressively

    GE Healthcare operator console upgrades for certain CT systems can cause progressive image rotation during scans. Images may rotate up to 56 degrees per exam, potentially affecting diagnostic accuracy.

    Product
    GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0242-2025·2024-12-11

    Chocolate Pudding Mix Recalled for Metal Fragment Contamination

    Monarch Instant Chocolate Pudding & Pie Filling Mix is being recalled due to metal fragments introduced during production. The affected product was distributed to 29 states.

    Product
    MONARCH INSTANT CHOCOLATE PUDDING & PIE FILLING MIX NATURALLY AND ARTIFICIALLY FLAVORED, NET WT. 24OZ, Case UPC 50758108068983 DISTRIBUTED BY US FOODSS, INC ROSEMONT, IL 60018
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0632-2025·2024-12-11

    MEDLINE Port Insertion Pack Recalled for Defective Component

    Medline is recalling 44 PORT INSERTION PACK kits nationwide. These kits contain SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0080-2025·2024-12-11

    Venofer Iron Sucrose Injection Recalled for Potential Glass Contamination

    American Regent is recalling specific lots of Venofer (iron sucrose) injection due to potential glass delamination from vials. The affected drug is distributed nationwide.

    Product
    VENOFER — VENOFER (IRON SUCROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0599-2025·2024-12-11

    Atellica CH β2-Microglobulin Reagent Produces Falsely Depressed Results

    Siemens Atellica CH β2-Microglobulin reagent may produce falsely depressed test results for samples between 18-30 mg/L, potentially leading to missed or delayed kidney disease diagnoses. No illnesses have been reported.

    Product
    Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 11097635
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0592-2025·2024-12-11

    BD Phoenix M50 Automated Microbiology System Service Credentials Exposed

    BD confirmed that service credentials used by technical support teams were accessed by an unauthorized actor, creating a risk of unauthorized access to BD microbiology systems and associated data.

    Product
    BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0582-2025·2024-12-11

    Cook Medical HEMO-7-EU Hemospray Devices Recalled for Activation Knob Defect

    Cook Medical HEMO-7-EU Hemospray devices are being recalled because the activation knob may crack or break during use due to manufacturing defects. The affected devices were distributed to Argentina, Brazil, and Israel.

    Product
    Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0577-2025·2024-12-11

    Fluoroscopic X-ray System Hand Switch May Fail and Cause Unintended Radiation

    The Ziehm Vision R fluoroscopic x-ray system has a hand switch that may fail under mechanical stress and cause unintended radiation. Ziehm Imaging, Inc. is recalling 5 affected units distributed in the U.S.

    Product
    Ziehm Vision R. Iterventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0223-2025·2024-12-11

    Vanilla Instant Pudding Mix Recalled for Contamination with Metal Fragments

    DYMA Brands is recalling Culinary Secrest Originals Vanilla Instant Pudding Mix because a damaged sifter introduced metal fragments into the product. Consumers should not consume the product.

    Product
    CULINARY SECREST ORIGINALS VANILLA INSTANT PUDDING MIX NATURAL & ARTIFICIAL FLAVOR, NET WT. 24 OZ. (1.5 LB.) 680g, 8 UPC 22486 19071 2, Case UPC 30822486190706 and NET WT. 28 OZ. (1.75 LB.) 793g, UPC 8 22486 19070 5, Case UPC 30822486190706, MARKETED BY INDEPENDENT MARKETING ALLI
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-0252-2025·2024-12-11

    Jose Madrid Salsa Recalled for Undeclared Yellow Food Colorants

    Jose Madrid Salsa Chipotle Con Queso is being recalled because it contains undeclared Yellow #5 and Yellow #6 food colorants. These additives must be labeled and can trigger sensitivities in some consumers.

    Product
    Jose Madrid Salsa Chipotle Con Queso, Net Wt. 13 oz. (369g), packaged in glass jars; 12 jars per case
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-0524-2025·2024-12-11

    Fusion Pro 24 Laser Safety Interlock Fails, Allowing Dangerous Radiation Exposure

    Epilog Laser Corp. is recalling Fusion Pro 24 Model 17000 laser systems because an incorrectly placed interlock device allows the front-loading door to open during operation, potentially exposing users to Class 4 laser radiation.

    Product
    Fusion Pro 24, Model 17000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0236-2025·2024-12-11

    Fruit Punch Recalled Due to Metal Fragment Contamination Risk

    Sysco Fruit Punch 24-ounce products are recalled due to metal fragments introduced during dextrose production. Consumers should not consume the affected product and contact their retailer for refund or replacement.

    Product
    SYSCO FRUIT PUNCH, NET WT. 24OZ, Case UPC 10074865093221, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
    Category
    Food
    Distribution
    30 states
  • HighFDA (Drugs)·D-0076-2025·2024-12-11

    Levothyroxine Sodium Tablets Recalled Due to Subpotency Nationwide

    Accord Healthcare is recalling Levothyroxine Sodium 75 mcg tablets (Lot D2300191, expiring 12/31/2025) distributed nationwide due to subpotency. Affected patients should contact their healthcare provider.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0103-2025·2024-12-11

    Prescription Drug Sunitinib Malate Subject to Label Mix-Up Recall

    AvKARE is recalling 40 bottles of Sunitinib Malate Capsules due to a label mix-up. The affected lot was distributed nationwide in the United States.

    Product
    SUNITINIB MALATE — SUNITINIB MALATE (SUNITINIB MALATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0110-2025·2024-12-11

    Cinacalcet Tablets Recalled Due to Nitrosamine Impurity Exceeding Limits

    AvKARE is recalling 2,796 bottles of Cinacalcet Tablets (90 mg) nationwide due to manufacturing deviations resulting in N-Nitroso-Cinacalcet above acceptable intake limits.

    Product
    Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0612-2025·2024-12-11

    GE Healthcare CT systems produce progressively rotated images in scan modes

    Certain GE Healthcare CT systems can produce progressively rotated images during helical and cardiac scans. Images may rotate up to 56 degrees, potentially affecting diagnosis if the rotation is not detected.

    Product
    GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0251-2025·2024-12-11

    Apple Wedge Apple Cider Recalled for Elevated Patulin Levels

    Apple Wedge 100% Pasteurized Apple Cider with code C3419 was recalled for containing patulin at 78 ppb, exceeding the FDA limit of 50 ppb. Products were distributed to GA, NC, SC, and FL.

    Product
    No Preservatives 100% CIDER Pasteurized APPLE WEDGE CIDER 1/2 Gal. (1.89L) HENDERSONVILLE, NC 28792 Keep Refrigerated Produce of USA UPC 0 36482 64000 7
    Category
    Food
    Distribution
    4 states