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.

14376–14400 of 27263

  • HighFDA (Drugs)·D-0078-2024·2023-11-08

    TUMS Antacid Tablets Recalled for Glass Mineral Wool Contamination

    GlaxoSmithKline is recalling TUMS Antacid 1000 mg chewable tablets in Assorted Berries flavor due to glass mineral wool contamination found in some bottles. Product was distributed nationwide.

    Product
    TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-05, UPC 3-0766-3072-14-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0203-2024·2023-11-08

    Coapt Dome Electrode Gen2 System Recalled for Burn Risk

    Coapt LLC is recalling the Dome Electrode Gen2 system due to potential burns or blistering from exposure to sunlight, warm temperatures exceeding 12 hours, or battery damage.

    Product
    Coapt Dome Electrode, Gen2 system, cutaneous electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0074-2024·2023-11-08

    FDA Recalls TUMS Antacid Tablets for Glass Mineral Wool Contamination

    GlaxoSmithKline is recalling TUMS Antacid tablets (Lot HA7G, expiration 8/31/2027) due to contamination with glass mineral wool. The product was distributed nationwide.

    Product
    TUMS — TUMS (CALCIUM CARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0201-2024·2023-11-08

    RX Modena Clinical Chemistry Analyzer Recalled for Incorrect Rerun Results

    Randox Laboratories is recalling the RX Modena-IVD Clinical Chemistry Analyzer nationwide due to parameter re-run settings that may fail to function correctly when samples are outside the assay range, potentially resulting in incorrect test results.

    Product
    RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0169-2024·2023-11-08

    McGrath Mac 2 Disposable Laryngoscope Blades Recalled for Ineffective Anti-Fog Coating

    Covidien recalled 42,367 McGrath Mac 2 disposable laryngoscope blades due to an ineffective anti-fog agent that may cause screen condensation and visual obstruction during intubation procedures.

    Product
    McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0195-2024·2023-11-08

    Siemens Cios Alpha X-ray system software defect may cause patient misdiagnosis

    Siemens Cios Alpha (VA30) C-arm X-ray systems have a software issue that may not meet updated DIN and IEC standards. This defect could result in patient misdiagnosis or unnecessary repeat imaging.

    Product
    Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0202-2024·2023-11-08

    RX Monaco-IVD Clinical Chemistry Analyzer rerun feature may report incorrect results

    Randox Laboratories is recalling 13 RX Monaco-IVD Clinical Chemistry Analyzers with a rerun feature defect that may report incorrect test results when samples are outside normal assay range. Units were distributed nationwide including Puerto Rico.

    Product
    RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0215-2024·2023-11-08

    Cepheid Xpert Xpress Strep A test kits may produce invalid results

    Cepheid is recalling Xpert Xpress Strep A test kits because pipettes may fail to dispense adequate sample volume, potentially resulting in invalid or absent test results.

    Product
    Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0326-2024·2023-11-08

    Nature's Path Pumpkin Spice Waffles Recalled for Undeclared Peanut Allergen

    Nature's Path Organic Pumpkin Spice Waffles are being recalled due to undeclared peanut allergen. About 6,908 cases were distributed across 17 states.

    Product
    Nature's Path Organic Pumpkin Spice Waffles, 7 oz., UPC 0 5844959077 4
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-0216-2024·2023-11-08

    Cepheid Xpert Xpress Strep A test kits may produce invalid results

    Cepheid is recalling 1,413 Xpert Xpress Strep A test kits due to a defect in the included pipettes. Defective pipettes may fail to dispense adequate sample volume, resulting in invalid test results or no test result.

    Product
    Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2024·2023-11-08

    AZUR CX 35 Peripheral Coil System Detachable Recalled for Unsealed Pouch Packaging

    MicroVention is recalling 14 units of the AZUR CX 35 Peripheral Coil System due to unsealed pouch packaging that could compromise device sterility. The affected units were distributed across eight states.

    Product
    AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0081-2024·2023-11-08

    Gynazole 1 Butoconazole Vaginal Cream Recalled for Formulation Error

    Padagis US LLC is recalling Gynazole 1 butoconazole nitrate vaginal cream nationwide due to a manufacturing error where hydrophilic colloidal silica was used instead of hydrophobic colloidal silica.

    Product
    GYNAZOLE 1 — GYNAZOLE 1 (BUTOCONAZOLE NITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0084-2024·2023-11-08

    Liothyronine Sodium Tablets Recalled for Failed Impurity Specifications

    Sun Pharmaceutical is recalling approximately 2,304 bottles of Liothyronine Sodium Tablets, USP, 25 mcg (lot DNC2204A) due to failed impurity and degradation specifications. The affected medication was distributed nationwide.

    Product
    LIOTHYRONINE SODIUM — LIOTHYRONINE SODIUM (LIOTHYRONINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0196-2024·2023-11-08

    Siemens X-Ray Systems Software Issue May Cause Patient Misdiagnosis

    Siemens Medical Solutions USA is recalling 367 mobile X-ray systems (186 Cios Flow and 181 Cios Spin) due to a software issue that may result in patient misdiagnosis and repeat radiation exposure. Affected units were distributed nationwide.

    Product
    ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive image acquisition modes. Material Number: 11108110 (2)Cios Spin- a mobile x-ray system designed to provide x-ray imaging of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0314-2024·2023-11-08

    Crush Orange Soda Recalled Due to Plastic Foreign Material

    Pepsi Beverages is recalling Crush Orange Soda 24-packs due to plastic foreign material found in some cans. The recall affects 184 cases distributed in Minnesota with lot code JUL2924XXXXMC10243 and a best-by date of July 29, 2024.

    Product
    Crush Orange Soda, 24 Pack. 24 - 12 oz. cans. Caffeine Free. Contains No Juice. UPC 0 78000-01309 2. Produced under the Authority of Dr Pepper/Seven Up, Inc., 6425 Hall of Fame Lane, Frisco, TX 75034
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0210-2024·2023-11-08

    Endoscopic Vessel Harvesting System Recalled for Incorrect Outer Box Packaging

    Vasoview 6 Pro endoscopic vessel harvesting systems were packaged in incorrect outer boxes displaying artwork for a different device (Vasoview Hemopro 2). The inner labels and product documentation are correct.

    Product
    Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork for Vasoview Hemopro 2 (HP2).
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0205-2024·2023-11-08

    Pediatric Tracheostomy Tube Recalled Due to Incorrect Box Expiration Date Label

    Smiths Medical recalls a pediatric tracheostomy tube because the outer box shows an incorrect expiration date (3/17/2021) while the actual product has the correct date (3/17/2026). The discrepancy could cause confusion about product validity.

    Product
    Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Drugs)·D-0082-2024·2023-11-08

    Iodine Solution Recalled for Manufacturing Compliance Deviations

    Safecor Health recalls Strong Iodine Solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The prescription product was distributed in multiple lots across the U.S.

    Product
    STRONG IODINE SOLUTION — STRONG IODINE SOLUTION (STRONG IODINE SOLUTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0085-2024·2023-11-08

    Bisoprolol Fumarate and Hydrochlorothiazide Tablets Recalled for Failed Quality Specifications

    Glenmark Pharmaceuticals is recalling Bisoprolol Fumarate and Hydrochlorothiazide Tablets due to failed impurities and degradation specifications. The recall affects 480 bottles distributed nationwide.

    Product
    BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0080-2024·2023-11-08

    Opium Tincture recalled for subpotent morphine content nationwide

    Edenbridge Pharmaceuticals recalled opium tincture nationwide because the morphine concentration fell below labeled potency. The voluntary recall affected 4,548 bottles.

    Product
    OPIUM TINCTURE DEODORIZED — OPIUM TINCTURE DEODORIZED (MORPHINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0212-2024·2023-11-08

    Hillrom Progressa+ Hospital Beds Recalled for Static Electricity Risk

    Hillrom Progressa+ hospital beds (499 units) are being recalled due to potential static electricity buildup that could cause mild shock to operators during transport. The affected units were distributed nationwide.

    Product
    HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A001973, and P7501A001974
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0209-2024·2023-11-08

    Abbott NT2000iX radiofrequency generator serviced with out-of-tolerance tool

    Abbott is recalling 34 NT2000iX radiofrequency generators that were serviced using an out-of-tolerance calibration tool, which may have provided inaccurate measurement results for capacitance failures.

    Product
    Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0217-2024·2023-11-08

    DBS Lead Device Recall: Use By Date Label Discrepancy

    Medtronic is recalling a small number of LEAD 3387S-40 deep brain stimulation devices due to discrepancies in the Use By Date printed on the outer package versus the individual product label.

    Product
    LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0204-2024·2023-11-08

    Coapt ControlSeal Electrode Recalled Due to Burn and Blistering Risk

    Coapt LLC is recalling 109 ControlSeal Electrodes due to risk of minor burns or blistering if exposed to direct sunlight or warm temperatures exceeding 12 hours, or if the battery is damaged.

    Product
    Coapt ControlSeal Electrode, cutaneous EMG Electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0197-2024·2023-11-08

    Quest Medical Recalls Q2 Multiport Intravenous Extension Sets

    Quest Medical is recalling 17,700 Q2 Multiport Extension Sets distributed in the US and Canada. The nature of the defect is not detailed in available source documentation.

    Product
    Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps.
    Category
    Medical Device
    Distribution
    19 states