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.

17151–17175 of 88183

  • HighFDA (Food)·F-1378-2023·2023-08-16

    Semolina linguine pasta recalled for undeclared wheat allergen

    Bellingham Pasta Co is recalling semolina linguine due to missing wheat allergen declaration on the label. Consumers with wheat allergies may be at risk.

    Product
    Semolina Linguine, net wt. 14oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bellingham Pasta Co. Ingredients Semolina Flour, Water, Egg, dusted with Brown Rice Flour. Keep Refrigerated. UPC 8 98975 00204 0.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2346-2023·2023-08-16

    LINK MP Monoblock Hip Stem trial instruments recalled for difficulty in removal

    Waldemar Link is recalling 24 LINK MP Monoblock Hip Stem trial instruments due to increased force required to remove them after impaction, which may prolong surgery or require procedure modification.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-115/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2358-2023·2023-08-16

    FDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives

    Ortho-Clinical Diagnostics is recalling VITROS Troponin I ES Calibrators because reagent packs may contain incorrect wells that could produce false negative results. The recall affects 4,013 units distributed worldwide.

    Product
    VITROS Immunodiagnostic Products Troponin I ES Calibrators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1390-2023·2023-08-16

    Sweet Alchemy ice cream recalled for undeclared allergens

    Sweet Alchemy Strawberry Rhubarb Crisp ice cream sold in Washington has been recalled because its labels do not declare the presence of milk, egg, and wheat allergens.

    Product
    Sweet Alchemy Strawberry Rhubarb Crisp ice cream, distributed in cups and pints. Label declares company name, flavor name, but does not declare ingredients and allergens.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1367-2023·2023-08-16

    Bellingham Pasta Co Linguine Recalled Due to Undeclared Wheat Allergen

    Bellingham Pasta Co is recalling 190 packages of Semolina Lemon Black Pepper Linguine because the label declares semolina flour but fails to declare wheat as an ingredient, posing a risk to consumers with wheat allergies.

    Product
    Semolina Lemon Black Pepper Linguine, net wt. 14oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bellingham Pasta Co. Ingredients Semolina Flour, Water, Egg, Lemon, Black Pepper, dusted with Brown Rice Flour. Keep…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1368-2023·2023-08-16

    Semolina Vegan Rigatoni Pasta Recalled for Undeclared Wheat Allergen

    Bellingham Pasta Co is recalling Semolina Vegan Rigatoni due to undeclared wheat allergen in the semolina flour ingredient.

    Product
    Semolina Vegan Rigatoni, net wt. 13oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bellingham Pasta Co. Ingredients Semolina Flour, Water, dusted with Brown Rice Flour. Keep Refrigerated. UPC 8 98975 00234 7.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1373-2023·2023-08-16

    Semolina Gemelli Pasta Recall for Undeclared Wheat Allergen

    Bellingham Pasta Co. is recalling Semolina Gemelli pasta because the label does not declare wheat, a major allergen, despite wheat being an ingredient. Consumers with wheat allergies should not consume this product.

    Product
    Semolina Gemelli, net wt. 13oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bellingham Pasta Co. Ingredients Semolina Flour, Water, Egg, dusted with Brown Rice Flour. Keep Refrigerated. UPC 8 98975 00227 9.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2349-2023·2023-08-16

    Hip Stem Trial Instrument Difficult to Remove After Impaction

    LINK MP Monoblock hip stem trial instruments may require increased force to remove after impaction, potentially prolonging surgery or requiring procedure modification. No injuries or illnesses have been reported.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-118/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2363-2023·2023-08-16

    Surgical Spinal Tap Device Recalled for Incorrect Laser Marking

    Medtronic is recalling Solera Awl Tip Tap surgical devices due to incorrect laser marking. Thirteen devices were distributed in Florida, Colorado, Indiana, South Carolina, Texas, and Utah.

    Product
    CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2365-2023·2023-08-16

    Medtronic InterStim Ground Pad Recalled for Incorrect Expiration Date Label

    Medtronic is recalling InterStim Self-Adhesive Ground Pad (lot 60347246) due to incorrect expiration date labeling. Affected units were distributed internationally including to Iran.

    Product
    Medtronic InterStim Ground Pad REF 041826
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2343-2023·2023-08-16

    Olympus Endoscope Reprocessor OER-Mini Labeling Revised for Device Compatibility

    Olympus revised labeling for the OER-Mini endoscope reprocessor. The company removed LF-V and LF-P endoscopes from the list of compatible devices and updated sterilization procedures.

    Product
    Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1082-2023·2023-08-16

    Dofetilide Capsules Recalled Due to Out-of-Specification Content Uniformity

    Sun Pharmaceutical recalls Dofetilide 500 mcg capsules nationwide due to out-of-specification results in content uniformity testing. Affected lot DNE0217A with expiration 01/2025 may not meet pharmaceutical specifications.

    Product
    DOFETILIDE — DOFETILIDE (DOFETILIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2392-2023·2023-08-16

    Canon Medical INFX-8000C Tableside Console PWB Requires Replacement

    Canon Medical has recalled 12 INFX-8000C tableside consoles due to a printed circuit board that may require replacement. Though procedures may be delayed, x-ray operations can continue using alternative controls.

    Product
    INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2400-2023·2023-08-16

    MR 7700 Magnetic Resonance System Diagnostic Cable Installation Defect

    Philips MR 7700 Magnetic Resonance systems may have an improperly installed diagnostic cable. The cable does not impact system functionality or patient safety.

    Product
    MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2353-2023·2023-08-16

    LINK MP Hip Stem Difficult to Remove After Surgical Implantation

    Waldemar Link is recalling LINK MP Monoblock hip stem prosthetics that may require increased force to remove after surgical implantation, potentially prolonging surgery.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-22/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2399-2023·2023-08-16

    MRI System Cable Installation Issue During Service Setup

    Philips Ingenia Elition S MR systems may have an improperly installed cable connecting the SmokeDetector Interlock to the host PC. This affects service diagnostics only and does not impact system functionality.

    Product
    Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2398-2023·2023-08-16

    Philips Ingenia Elition X MR Systems Diagnostic Cable Installation Issue

    Philips is recalling 601 Ingenia Elition X MR systems because a diagnostic cable may not have been properly installed, though system operation is not affected.

    Product
    Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2281-2023·2023-08-09

    Impella RP Flex cardiac pump recalled for thrombus formation risk

    The Impella RP Flex cardiac pump has been recalled due to a higher-than-expected rate of blood clot formation. Blood clots may reduce cardiac support or cause hemolysis.

    Product
    Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1081-2023·2023-08-09

    Prescription Birth Control Tablets Recalled for Failed Stability Testing

    Lupin Pharmaceuticals is recalling TYDEMY birth control tablets due to failed stability testing. Consumers should contact their healthcare provider.

    Product
    TYDEMY — TYDEMY (DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1302-2023·2023-08-09

    Pamana Mini Fruit Jelly Cup Recalled Due to Choking Hazard

    Foremost Foods International, Inc. is recalling Pamana brand Mini Fruit Jelly Cups (11,040 units) distributed in the United States and Canada due to a potential choking hazard. Consumers should stop using the product immediately.

    Product
    Pamana brand Mini Fruit Jelly Cup 35.27 oz. Assorted Flavors 6 units per case Item #416705
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1303-2023·2023-08-09

    Pamana Brand Lychee Jelly Cups recalled for potential choking hazard

    Foremost Foods International, Inc. is recalling Pamana Brand Mini Fruit Jelly Cup in Lychee flavor due to a potential choking hazard affecting 11,040 units distributed in the United States and Canada.

    Product
    Pamana Brand Mini Fruit Jelly Cup 35.27 oz. Lychee Flavor 6 units per case Item #416704
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1304-2023·2023-08-09

    Pamana Brand Mini Fruit Jelly Cups Recalled for Choking Hazard

    Foremost Foods International is recalling Pamana Brand Mini Fruit Jelly Cups due to a potential choking hazard. Approximately 11,040 units distributed in the United States and Canada are affected.

    Product
    Pamana Brand Mini Fruit Jelly Cup 35.27 oz. Mango Flavor 6 units per case Item #416706
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-1021-2023·2023-08-09

    Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency

    Central Admixture Pharmacy Services recalls Cardioplegia Solution (Lot 36-253947) due to lack of sterility assurance and insufficient decontamination validation. Healthcare facilities should discontinue use and contact the manufacturer.

    Product
    CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, IV Bag, Total Volume = 572.64 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1051-2023·2023-08-09

    Fentanyl Injectable Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling fentanyl injections because sterilization procedures were not properly validated, raising infection risks from potential contamination.

    Product
    fentaNYL, 5000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5
    Category
    Drug
    Distribution
    Distributed nationwide