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.

13251–13275 of 27206

  • LowFDA (Devices)·Z-0737-2024·2024-01-24

    V. Mueller Bandage Scissors recalled for pink dye staining on handles

    Steris Corporation is recalling V. Mueller Universal Bandage Scissors (Model SU2014-001) due to an incorrect resin carrier in the handle cover. Pink dye residue may appear on scissors and sterilization pouches after processing.

    Product
    V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended to cut through tape and bandages Model: SU2014-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0699-2024·2024-01-17

    Eban's Bakehouse Cookies Recalled for Undeclared Milk and Soy Allergens

    Eban's Bakehouse Sweet Indulgences cookies are recalled due to undeclared milk and soy allergens not listed on the label. Consumers with allergies to milk or soy should not consume this product.

    Product
    Eban's Bakehouse Sweet Indulgences - Peanut Butter Chocolate Chunk (12 pieces/cookies) packaged in 11.85oz cardboard candy box with clear plastic cover. Retail sales are by box, Wholesale are 6 boxes per case.
    Category
    Food
    Distribution
    33 states
  • SevereFDA (Food)·F-0700-2024·2024-01-17

    Eban's Bakehouse Turtle Brownie Cookies Recalled for Undeclared Milk and Soy

    Eban's Bakehouse LLC is recalling Turtle Brownie cookies that contain undeclared milk and soy allergens. Consumers with allergies should not consume the product.

    Product
    Eban's Bakehouse Sweet Indulgences - Turtle Brownie (12 pieces/cookies) packaged in 11.85oz cardboard candy box with clear plastic cover. Retail sales are by box, Wholesale are 6 boxes per case.
    Category
    Food
    Distribution
    33 states
  • SevereFDA (Drugs)·D-0220-2024·2024-01-17

    Prescription Vigabatrin Powder Recalled for Defective Container Leakage Risk

    InvaGen Pharmaceuticals recalls Vigabatrin for Oral Solution nationwide due to defective containers that may leak. Consumers with affected lot should contact their pharmacy or healthcare provider.

    Product
    VIGABATRIN — VIGABATRIN (VIGABATRIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0695-2024·2024-01-17

    Eban's Bakehouse Cookies Recalled for Undeclared Milk and Soy Allergens

    Eban's Bakehouse Sweet Indulgences cookies are being recalled due to undeclared milk and soy allergens. Consumers with allergies should not consume these products and should discard or return them.

    Product
    Eban's Bakehouse Sweet Indulgences - Brown Butter Honey Pistachio (12 pieces/cookies) packaged in 11.85oz cardboard candy box with clear plastic cover. Retail sales are by box, Wholesale are 6 boxes per case.
    Category
    Food
    Distribution
    33 states
  • SevereFDA (Food)·F-0697-2024·2024-01-17

    Eban's Bakehouse Cookies Recalled for Undeclared Milk and Soy Allergens

    Eban's Bakehouse has recalled Sweet Indulgences Chocolate Chili Coconut cookies due to undeclared milk and soy allergens. The product was distributed nationwide and poses a risk to allergic consumers.

    Product
    Eban's Bakehouse Sweet Indulgences - Chocolate Chili Coconut (12 pieces/cookies) packaged in 11.85oz cardboard candy box with clear plastic cover. Retail sales are by box, Wholesale are 6 boxes per case.
    Category
    Food
    Distribution
    33 states
  • SevereFDA (Food)·F-0703-2024·2024-01-17

    Maple Nut Fudge Recalled Due to Undeclared Egg Allergen

    Valley View Candies is recalling Maple Nut Fudge 8oz containers due to undeclared egg allergen. The product was distributed to retail stores in Iowa.

    Product
    Maple Nut Fudge, 8oz, packaged in clear, plastic clamshell.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0696-2024·2024-01-17

    Eban's Bakehouse cookies recalled for undeclared milk and soy allergens

    Eban's Bakehouse Sweet Indulgences Brown Butter Snickerdoodles are recalled due to undeclared milk and soy allergens. The FDA Class I recall affects 876 units distributed to 33 states.

    Product
    Eban's Bakehouse Sweet Indulgences - Brown Butter Snickerdoodle (12 pieces/cookies) packaged in 11.85oz cardboard candy box with clear plastic cover. Retail sales are by box, Wholesale are 6 boxes per case.
    Category
    Food
    Distribution
    33 states
  • SevereFDA (Food)·F-0694-2024·2024-01-17

    Eban's Bakehouse Sweet Indulgences cookies recalled for undeclared milk and soy

    Eban's Bakehouse LLC is recalling Sweet Indulgences cookies for containing undeclared milk and soy allergens, which pose serious health risks to allergic consumers.

    Product
    Eban's Bakehouse Sweet Indulgences - Variety Pack (12 pieces/cookies) packaged in 11.85oz cardboard candy box with clear plastic cover. Retail sales are by box, Wholesale are 6 boxes per case.
    Category
    Food
    Distribution
    33 states
  • SevereFDA (Food)·F-0701-2024·2024-01-17

    FDA recalls Chocolate Fudge for undeclared egg allergen

    Valley View Candies recalled Chocolate Fudge due to undeclared egg allergen. The recall affects 348 containers distributed to retail stores in Iowa.

    Product
    Chocolate Fudge, 8oz, packaged in clear, plastic clamshell.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0698-2024·2024-01-17

    Eban's Bakehouse Lemon Sugar Cookies Recalled for Undeclared Milk and Soy

    Eban's Bakehouse Sweet Indulgences lemon cookies are being recalled due to undeclared milk and soy allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    Eban's Bakehouse Sweet Indulgences - Lemon Sugar Cookie/Lemon Shortbread (12 pieces/cookies) packaged in 11.85oz cardboard candy box with clear plastic cover. Retail sales are by box, Wholesale are 6 boxes per case.
    Category
    Food
    Distribution
    33 states
  • SevereFDA (Food)·F-0704-2024·2024-01-17

    Peanut Butter Fudge Recalled for Undeclared Egg Allergen

    All lots of Peanut Butter Fudge sold in Iowa are recalled due to undeclared egg allergen. The manufacturer initiated the voluntary recall.

    Product
    Peanut Butter Fudge, 8oz, packaged in clear, plastic clamshell.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0694-2024·2024-01-17

    SoClean 3 CPAP Cleaner Recalled Over Ozone Exposure Risk

    SoClean, Inc is voluntarily recalling 40,075 units of the SoClean 3 sleep equipment cleaner due to potential ozone gas exposure. The manufacturer is providing an updated user manual with safety instructions and a protective hose and mask adapter.

    Product
    SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0683-2024·2024-01-17

    Sensis Vibe Hemo Medical Device Software May Crash

    Siemens is recalling 331 units of the Sensis Vibe Hemo medical device due to a potential software crash in its documentation functionality application. Units affected are distributed in California, Connecticut, and Florida.

    Product
    Sensis Vibe Hemo
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0651-2024·2024-01-17

    Abiomed Introducer Kit Recalled for Compromised Sterile Barrier

    Abiomed is recalling introducer kits due to holes in the outer pouch that compromise the sterile barrier. Non-sterile product could allow microbial contamination, leading to infection such as bacteremia or sepsis.

    Product
    Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-0053
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0681-2024·2024-01-17

    Abbott Alinity c Chemistry Analyzer Contains Unlabeled Latex Subcomponent

    Abbott Laboratories is recalling 1,127 Alinity c Processing Module chemistry analyzers because unlabeled latex subcomponents are present. Users with latex allergies may experience serious allergic reactions upon contact.

    Product
    Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinit
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0653-2024·2024-01-17

    Oscor Intro Catheter Introducer Kit: Compromised Sterile Barrier

    Abiomed is recalling Oscor Intro Introducer Kits due to holes in the outer pouch that may compromise the sterile barrier, potentially exposing patients to harmful bacteria and infections including bacteremia and sepsis.

    Product
    Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0669-2024·2024-01-17

    Vascu-Guard Peripheral Vascular Patch marketing materials contain inaccurate information

    Baxter Healthcare is recalling marketing materials for its Vascu-Guard Peripheral Vascular Patch because a cardiovascular surgery brochure contains inaccurate content conflicting with official Instructions for Use and Prescribing Information.

    Product
    Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM GLOBAL, c) VG0106N: 1X6 CM GLOBAL, d) VG0209N: 2X9 CM GLOBAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0660-2024·2024-01-17

    Baxter Preveleak Surgical Sealant recall for inaccurate marketing brochure

    Baxter Healthcare has recalled a marketing brochure for its Preveleak Surgical Sealant due to inaccurate content that does not align with the product's Instructions for Use. Healthcare providers and consumers should consult the accurate product Instructions for Use and Prescribing Information.

    Product
    Baxter Preveleak Surgical Sealant, Product Codes: ADS201808
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0650-2024·2024-01-17

    Abiomed Introducer Kit Sterile Barrier Compromise Risks Infection

    Abiomed introducer kits may have holes in the outer pouch, compromising sterility and exposing patients to potential microbial contamination. This could lead to serious infections including bacteremia or sepsis.

    Product
    Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3052
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0654-2024·2024-01-17

    Abiomed Introducer Kits recalled due to sterile barrier compromise

    Abiomed is recalling Introducer Kits because holes in the outer pouch may compromise the sterile barrier, risking bacterial infection. The kits are distributed nationwide and internationally.

    Product
    Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3056
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0705-2024·2024-01-17

    Cardiac Stress Testing System may produce distorted electrocardiogram readings

    The Q-Stress Cardiac Stress Testing System version 6 may distort electrocardiogram (ECG) readings when the Source Consistency Filter is enabled. Healthcare facilities should verify ECG readings and consult product documentation.

    Product
    Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX: d) QS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA: e) QS6 AM12Q
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0648-2024·2024-01-17

    Abiomed Oscor Introducer Kit sterile barrier holes risk infection

    Abiomed Oscor Introducer Kits may have holes in the outer pouch that compromise sterility. This could allow bacteria to enter the patient's bloodstream during catheter insertion.

    Product
    Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0649-2024·2024-01-17

    Abiomed Introducer Kit recalled due to sterile barrier compromise risk

    Abiomed is recalling Introducer Kits (part 0052-3021) with holes in the outer pouch that compromise the sterile barrier, potentially exposing patients to infection. The kits were distributed nationwide and internationally.

    Product
    Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the body
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0223-2024·2024-01-17

    Tizanidine 4mg Tablets Recalled for Contamination with 2mg Tablets

    Dr. Reddy's Laboratories is recalling Tizanidine 4mg tablets due to the presence of 2mg tablets in bottles. About 38,952 bottles were distributed nationwide.

    Product
    TIZANIDINE — TIZANIDINE (TIZANIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide