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.

8151–8175 of 26961

  • HighFDA (Devices)·Z-0638-2025·2024-12-11

    MEDLINE medical convenience kits recalled for defective component

    Medline is recalling medical convenience kits (CLEAN CLOSING PACK and CLEAN CLOSURE PACK GREEN) distributed nationwide because they contain a SafeAir Smoke Evacuation Pencil component that was recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84667
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0226-2025·2024-12-11

    Gordon CHOICE Lemonade Mix Recalled for Metal Fragment Contamination

    Gordon CHOICE Lemonade Beverage Mix is being recalled for metal fragment contamination in the product. Consumers should stop using affected packages and contact the manufacturer.

    Product
    Gordon CHOICE Lemonade Beverage Mix Naturally Flavored Low Calorie Instant LOW CAL LEMONADE, NET WT. 8.6 OZ (243 g), UPC 0 93901 59605 5, Case UPC 10093901596052, FOR DISTRIBUTION EXCLUSIVELY BY PARA SU DISTRIBUCION EXCLUSIVA POR GORDON FOOD SERVICE WYOMING, MI 49509
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-0240-2025·2024-12-11

    THIRSTER Lemonade Drink Mix Recalled for Metal Fragment Contamination

    DYMA Brands recalls THIRSTER Lemonade Drink Mix because a damaged sifter used in dextrose production introduced metal fragments into the product. The product was distributed to 29 states.

    Product
    THIRSTER Lemonade Drink Mix NATURALLY FLAVORED LOW CALORIE, NET WT. 8.6 OZ (244 g), UPC 7 58108 39736 4, Case UPC 50758108397359, DISTRIBUTED BY US FOODS, INC. ROSEMONT, IL 60018
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0643-2025·2024-12-11

    MEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Component

    MEDLINE is recalling surgical convenience kits nationwide because they contain smoke evacuation pencil components from a Stryker product that was previously recalled. The affected kits are used in robotic and laparoscopic surgical procedures.

    Product
    MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF CDS980998L; 4) ROBOTIC PROCEDURE, REF CDS982128P; 5) ROBOTIC, REF CDS984262N; 6) GYN LAPAROSCOPY, REF CDS984900M; 7) GYN LAP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0082-2025·2024-12-11

    Prescription Drug Recall: Venofer Iron Sucrose Vials with Glass Delamination Risk

    American Regent, Inc. is recalling specific lots of Venofer (iron sucrose) injection due to potential glass delamination in vials. The intravenous drug distributed nationwide may contain particulate matter.

    Product
    VENOFER — VENOFER (IRON SUCROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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 (Devices)·Z-0611-2025·2024-12-11

    GE Healthcare CT System May Produce Rotated Diagnostic Images

    GE Healthcare's Revolution Maxima M and related CT systems may produce progressively rotated images during scans, potentially compromising diagnostic accuracy. Rotation increases with each image, reaching up to 56 degrees.

    Product
    GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0604-2025·2024-12-11

    CT imaging systems may display progressively rotated images in certain scan modes

    Certain GE Healthcare CT systems may display progressively rotated images, particularly during helical, cine, or cardiac scans. The rotation increases with each image, potentially reaching 56 degrees maximum.

    Product
    GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
    Category
    Medical Device
    Distribution
    0 states
  • 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 (Devices)·Z-0586-2025·2024-12-11

    Medical Device Data Management Software Affected by Unauthorized Service Credential Access

    Service credentials for BD EpiCenter Data Management System were accessed by an unauthorized actor. This creates a risk of unauthorized access to the software and associated data until credentials are updated.

    Product
    BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0109-2025·2024-12-11

    Cinacalcet Tablets Recalled for Elevated Nitrosamine Impurity

    AvKARE is recalling 2,396 bottles of Cinacalcet Tablets 60 mg (Lot #44550) distributed nationwide due to CGMP deviations. The tablets contain N-Nitroso-Cinacalcet, a nitrosamine impurity, above acceptable intake limits.

    Product
    Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-0607-2025·2024-12-11

    GE Healthcare CT Imaging System May Produce Rotated Medical Images

    GE Healthcare CT systems may produce progressively rotated images during helical, cine, and cardiac scans. The issue affects 4 units worldwide and can cause rotations up to 56 degrees.

    Product
    GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • 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
  • ModerateFDA (Devices)·Z-0623-2025·2024-12-11

    Medline Medical Convenience Kits Recall Due to Recalled Component

    Medline is recalling certain medical convenience kits manufactured with SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker. The recall affects 182 units distributed nationwide.

    Product
    MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418L; 3) LOCAL BASIC, REF DYNJ34418M; 4) MINI LOCAL, REF DYNJ900287D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0645-2025·2024-12-11

    MEDLINE C-Section Kits Recalled for Defective Smoke Evacuation Component

    MEDLINE is recalling 58,765 C-section convenience kits nationwide that contain SafeAir Smoke Evacuation Pencil components recalled by manufacturer Stryker. Affected kits have specific lot numbers.

    Product
    MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; 3) C-SECTION, REF CDS980774M; 4) C-SECTION KIT, REF CDS981322AB; 5) C-SECTION KIT, REF CDS981322AC; 6) C-SECTION COMBINED CDS, REF CDS982398I; 7) C-SECTION
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0587-2025·2024-12-11

    BD COR PX Instrument Service Credentials Compromised; Update Required

    Becton Dickinson reports that technical support credentials for the BD COR PX Instrument were accessed by an unauthorized actor. Users should verify credential updates with BD to mitigate unauthorized access risk.

    Product
    BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0646-2025·2024-12-11

    MEDLINE Surgical Kits Recalled Due to Defective SafeAir Component

    Medline is recalling 3,452 units of surgical convenience kits nationwide due to a defective SafeAir Smoke Evacuation Pencil component previously recalled by Stryker. No illnesses or injuries have been reported.

    Product
    MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L; 4) DAY SURG LARGE VAG CDS, REF CDS984995N; 5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 6) D&C/HYSTEROSCOPY PACK, REF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0092-2025·2024-12-11

    Compliance Dishwashing Liquid and Antibacterial Soap recalled for microbial contamination

    Midlab Incorporated is recalling Compliance brand dishwashing liquid and antibacterial soap due to microbiological contamination from manufacturing process deviations. The product was distributed nationwide; no illnesses have been reported.

    Product
    Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal Corporation, 10232 Palm Drive, Santa Fe Springs, CA 90670
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0088-2025·2024-12-11

    Boardwalk Antibacterial Handsoap Refill Recalled for Microbial Specification Failure

    Midlab Incorporated is recalling boardwalk Antibacterial Handsoap Refill due to out-of-specification microbial test results. Affected lot 0711241 was distributed nationwide.

    Product
    boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North, Deerfield, IL 60015
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0087-2025·2024-12-11

    MAXIM Assure Antibacterial Hand Soap Recalled for Microbial Contamination

    Midlab Incorporated is recalling MAXIM Assure Antibacterial hand soap (Lot 0711241) nationwide due to out-of-specification microbial test results in the manufacturing process.

    Product
    MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0648-2025·2024-12-11

    Medline Recalls Convenience Kits with Recalled SafeAir Smoke Evacuation Pencil

    Medline is recalling 1,921 medical convenience kits distributed nationwide that contain SafeAir Smoke Evacuation Pencil components previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATARACT PACK, REF DYNJ43147G; 4) OSC OCULOPLASTIC PACK, REF DYNJ63329D; 5) OSC OCULOPLASTIC PACK, REF DYNJ63329F; 6) OCULAR PACK, REF DYNJ64138B; 7) OSC BRE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0637-2025·2024-12-11

    MEDLINE Burn Convenience Kits Recalled Due to Defective Component

    MEDLINE is recalling 486 burn convenience kits because they were manufactured using SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331D
    Category
    Medical Device
    Distribution
    Distributed nationwide