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.

15776–15800 of 88183

  • HighFDA (Devices)·Z-0386-2024·2023-11-29

    Surgical implant anchor plugs may contain metal burrs affecting insertion

    Biomet's Compress Device Short Anchor Plugs may contain metal burrs in the transverse holes, which can prevent proper insertion of surgical tools and extend surgery time. The affected devices are distributed nationwide and internationally.

    Product
    Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178566
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0110-2024·2023-11-29

    Hand Sanitizer Recalled for Chemical Contamination Above Specifications

    Integrity Biochem 70% alcohol hand sanitizer recalled due to acetal and acetaldehyde contamination above USP limits. The 55-gallon drums distributed in Oklahoma may not meet safety standards.

    Product
    Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-047-03
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0384-2024·2023-11-29

    Compress Device Short Anchor Plugs Recalled for Metal Burrs

    Biomet is recalling Compress Device Short Anchor Plugs (22 MM) used in orthopedic surgery because they may contain metal burrs in the transverse holes that could prevent drill or pin passage and extend surgical procedures.

    Product
    Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0325-2024·2023-11-29

    IRON assay kits recalled for inaccurate diagnostic results

    Sentinel CH SpA is recalling IRON assay kits (Reference Numbers 6K95-41 and 6K95-30) that may produce falsely elevated results. Affected lots could cause inaccurate iron measurements and delays in patient test reporting.

    Product
    IRON assay, Reference Numbers 6K95-41 and 6K95-30
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0362-2024·2023-11-29

    BreathTech Manual Resuscitators Recalled for Integrated Manometer Leak

    SunMed Holdings is recalling BreathTech manual resuscitators because the integrated manometer can leak, allowing patients to rebreathe exhaled CO2 during emergency airway management.

    Product
    Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. BreathTech Adult Resuscitator REF #s: BT5107F & BT5104P; 2. BreathTech Child Resuscitator REF #s: BT3030, BT3034, & BT3025; 3. BreathTech Infant…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0336-2024·2023-11-29

    Hysterovideoscope Models Recalled Due to Improper Channel Drying Risk

    Aizu Olympus is recalling Hysterovideoscope Model HYF-V units (27 devices) because the channel air drying process was not validated. Water remaining in device channels could pose an infection risk.

    Product
    Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0465-2024·2023-11-29

    Jeni's Splendid Ice Cream Recalled for Aluminum and Steel Contamination

    Jeni's Splendid Ice Cream Buttercream Birthday Cake is recalled for potential aluminum and stainless steel pieces in the product. Consumers should stop consuming and return all affected packages.

    Product
    Jeni's Splendid Ice Cream: Buttercream Birthday Cake Ice Cream packaged in paperboard pint cups with heat seals and paper lids - 8 pints per case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0375-2024·2023-11-29

    Biomet Compress Device Anchor Plugs Recalled for Metal Burrs

    Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent proper device function during surgery. The defect could result in extended surgical time.

    Product
    Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178410
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0333-2024·2023-11-29

    Gastroscope Devices Recalled for Inadequate Channel Drying Process

    Aizu Olympus recalls 680 gastroscope-EUS devices due to unvalidated channel drying. Water remaining in the channels poses contamination and infection risks.

    Product
    Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0399-2024·2023-11-29

    ORION Robotic Arm Recalled for Sudden Acceleration and Collision Risk

    The FDA recalls ORION robotic positioning arms used in radiation and radiology due to sudden acceleration or unintended movement that could cause patient collision with treatment room equipment. No injuries reported.

    Product
    ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0398-2024·2023-11-29

    Robotic patient positioning system may move unexpectedly after interruption

    The ORION System robotic arm used in radiation therapy may suddenly accelerate or move unexpectedly when motion resumes after an interruption, creating a risk of collision with stationary equipment.

    Product
    ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0113-2024·2023-11-29

    Buspirone Hydrochloride Tablets Recalled Due To Amlodipine Contamination Risk

    FDA recalls Buspirone Hydrochloride 10 mg tablets due to potential contamination with foreign Amlodipine Besylate tablets. The recall affects 1,344 blister cards distributed nationwide.

    Product
    BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0337-2024·2023-11-29

    Hysterofiberscope Model HYF-XP Channel Drying Process Flaw Poses Infection Risk

    Aizu Olympus is recalling HYF-XP hysterofiberscopes because the channel air drying process was not validated. Some repaired units have wet channels that could harbor contamination and pose infection risk.

    Product
    Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0377-2024·2023-11-29

    Biomet Anchor Plugs Recalled: Metal Burrs Prevent Proper Assembly

    Biomet's Compress Device Segmental Anchor Plugs are being recalled due to metal burrs in assembly holes. The defect prevents drill pins from passing through, potentially extending surgical time during implantation procedures.

    Product
    Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178414
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0320-2024·2023-11-29

    Medtronic Mo.Ma Ultra cerebral protection device labeling error recalled

    Medtronic is recalling 2,767 units of the Mo.Ma Ultra Proximal Cerebral Protection Device due to labeling errors on the manifold that result in incorrect identification of inflation and deflation ports.

    Product
    Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0112-2024·2023-11-29

    Prescription esomeprazole magnesium capsules recalled for failed impurity specifications

    Glenmark Pharmaceuticals recalled esomeprazole magnesium 20mg capsules nationwide due to out-of-specification organic impurities detected during stability testing. No illnesses have been reported.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0379-2024·2023-11-29

    Compress Device Short Anchor Plug recalled for potential metal burrs

    Biomet recalls Compress Device Short Anchor Plug devices due to potential metal burrs in transverse holes that may prevent proper drill and pin placement during orthopedic surgery, affecting units distributed worldwide.

    Product
    Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178554
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0370-2024·2023-11-29

    Orthopedic Anchor Plugs Recalled for Metal Burrs Preventing Proper Installation

    Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent drills or pins from passing through, potentially extending surgical procedures.

    Product
    Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0114-2024·2023-11-29

    Lisinopril Tablets Recalled for Stray Amlodipine Tablet Contamination

    NCS Healthcare recalled Lisinopril Tablets USP 20 mg nationwide due to potential presence of stray Amlodipine Besylate 10 mg tablets in certain lots. No illnesses have been reported.

    Product
    BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0463-2024·2023-11-29

    Dietary Supplement Recalled for Subpotent Folic Acid Content

    ActiPharma is recalling ACTIRON Dietary Supplement (Lot 13309, Exp. 01/26) distributed in Puerto Rico because FDA testing found the folic acid content did not meet the label claim.

    Product
    ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot 13309, Exp.: 01/26), UPC: 363102217104.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0462-2024·2023-11-29

    Frozen Gluten-Free Waffles Recalled for Potential Peanut Contamination

    Treehouse Foods is recalling multiple brands of frozen gluten-free blueberry waffles due to potential peanut contamination. Affected products were distributed in California, Iowa, Illinois, Ohio, and Texas.

    Product
    HEB Central Market Blueberry Buckwheat Gluten Free Waffle, 8.25oz, UPC 004122025365 Giant Eagle Blueberry Gluten Free Waffle, 11.3oz, UPC 030034944940 Topco Full Circle Market Gluten Free Waffles - Blueberry, 11.3oz, UPC 036800486980
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0380-2024·2023-11-29

    Compress Device Short Anchor Plugs recalled due to metal burrs

    Biomet is recalling Compress Device Short Anchor Plugs (14 MM) due to potential metal burrs in transverse holes that may prevent proper insertion during surgery. The defect may extend surgical time.

    Product
    Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178556
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0443-2024·2023-11-22

    Frozen Ice Cream Base Recalled for Undeclared Milk Allergen and Food Colorings

    Paradise Flavors LLC recalls Dulce de Leche ice-cream base (4 oz) for undeclared milk allergen and color additives. The recall affects 210 units distributed in Florida.

    Product
    DULCE DE LECHE, Ice-cream base, Natural flavor, artificial flavor and coloring., Distributed By Paradiose Flavors LLC. 4oz (120 mL). Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0429-2024·2023-11-22

    Paradise Flavors frozen cappuccino ice-cream recalled for undeclared milk

    Paradise Flavors LLC is recalling 60 units of its frozen cappuccino ice-cream (4 oz pouches) from Florida due to undeclared milk allergen, which poses a serious risk to consumers with milk allergies.

    Product
    CAPPUCCINO, Ice-cream base, natural flavoring, artificial flavoring. PARADISE FLAVORS. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state