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.

10551–10575 of 27089

  • HighFDA (Devices)·Z-2257-2024·2024-07-10

    Nalu Neurostimulation Kits Recalled for Manufacturing Defect and Device Failure

    Nalu Medical recalls 13 neurostimulation and peripheral nerve stimulation kits due to a manufacturing defect that may prevent the implantable pulse generator from functioning, stopping pain signal inhibition.

    Product
    Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2267-2024·2024-07-10

    Prostate Treatment Balloons Recalled Due to Fill Volume Mislabeling

    Angiodynamics is recalling IsoLoc Prostate Immobilization Balloons (ISO-100, Lot 5402) for mislabeling. Devices have 100cc fill volume but are labeled as ISO-60 (60cc).

    Product
    IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0570-2024·2024-07-10

    Budesonide USP drug ingredient recalled for glass contamination

    Medisca Inc. is recalling 113 bottles of Budesonide, USP (Micronized) 500 mg due to glass particulate matter contamination caused by manufacturing deviations. The product was distributed nationwide in the USA and Canada.

    Product
    Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2242-2024·2024-07-10

    ARTIS Angiography Systems Recalled for Potential Radiation Overdose

    Siemens ARTIS icono angiography systems with specific detector configurations may deliver higher radiation doses than intended in rare cases. The issue occurs during the first X-ray exposure after patient registration.

    Product
    ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2229-2024·2024-07-10

    Surgical Convenience Kits Recalled for Weak Seals Affecting Sterility

    Medline Industries recalls 7,673 surgical convenience kits due to weak Pure Pouch seals that may compromise sterility. Kits were distributed nationwide to healthcare facilities.

    Product
    Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile. b. Medline C-Section, Pack DYNJ902938J, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2236-2024·2024-07-10

    Acumatch L-Series Hip Implant Liners Recalled for Packaging Defect

    Exactech is recalling Acumatch L-Series hip implant liners because some units were packaged without the specified protective ethylene vinyl alcohol (EVOH) layer, which is required for proper device protection.

    Product
    Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2235-2024·2024-07-10

    Surgical retractor blade manufacturing defect could cause bone fracture

    SeaSpine Orthopedics is recalling Fathom Pedicle-Based Retractor C/C Blades due to manufacturing defects that could cause bone fracture. The recall affects 31 units distributed across nine US states.

    Product
    Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2240-2024·2024-07-10

    Siemens ARTIS Angiography Systems Recalled for Excessive Radiation Dose

    Siemens is recalling ARTIS angiography systems where the first X-ray after patient registration may use incorrect copper prefiltration, potentially resulting in higher radiation doses than intended.

    Product
    ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2237-2024·2024-07-10

    Beckman Coulter DxI 9000 Analyzer Tubing Malfunction Causes Test Errors

    Beckman Coulter DxI 9000 immunoassay analyzers may produce false or delayed test results due to pneumatic tubing disconnection during operation. Nine instruments are affected across the US and Europe.

    Product
    Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human bod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2225-2024·2024-07-10

    Sterile surgical kits recalled due to weak pouch seals risking contamination

    Medline sterile surgical kits are being recalled nationwide due to weak seals in the Pure Pouch component that may allow sterility breach. The recall affects 12,588 units distributed across 23 states.

    Product
    Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack #DYNJ47873L, containing a Pure Pouch with component Sterile Curved Kelly Hemostat, Reorder #66175.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2224-2024·2024-07-10

    Medline surgical convenience kits recalled for weak seal defects

    Medline Industries is recalling 12,588 sterile surgical convenience kits due to weak seals on Pure Pouch components that may breach sterility. Products were distributed nationwide across 23 states.

    Product
    Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. b. Medline Angiography Pack, Pack #DYNJ26488W, containing a Pure Pouch with compo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1457-2024·2024-07-10

    Frozen Eggplant Parmesan Recalled for Undeclared Wheat and Milk

    Italiamo brand frozen Eggplant Parmesan may contain undeclared wheat and milk allergens. Foreign language labeling prevented proper allergen disclosure.

    Product
    Italiamo brand Melanzane alla Parmigiana pregratinate (Eggplant Parmesan) 450g UPC: 20456436. Frozen product. Packaged in plastic tray with paper sleeve, 12 units in every case.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1458-2024·2024-07-10

    Energique Mineral Magic Dietary Supplement recalled for yeast and mold contamination

    Grato Holdings is recalling Energique Mineral Magic Dietary Supplement because of potential yeast and mold contamination. Affected lot numbers G11602 (06/21), G11747 (07/22), and G11723 (08/22) were distributed in the US and Canada.

    Product
    Energique Mineral Magic Dietary Supplement, 2 fl. oz (59 ml) bottle.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2247-2024·2024-07-10

    X-ray cart positioning arm bolt may loosen and fall onto patient

    A bolt securing the positioning arm on First Source iQ Flex M X-ray carts may come loose and fall onto patients. The recall involves 137 units distributed across the US, Korea, and Serbia.

    Product
    First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2265-2024·2024-07-10

    Abbott Liberta RC Pulse Generator Unexpectedly Shuts Down Periodically

    Abbott Liberta RC implantable pulse generators used for deep brain stimulation may unexpectedly turn off approximately every 50 days after activation, resulting in loss of therapy. Approximately 302 units have been recalled nationwide.

    Product
    Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0574-2024·2024-07-10

    FDA recalls Dream Cream topical product due to manufacturing quality violations

    Little Moon Essentials voluntarily recalls Dream Cream due to manufacturing quality control violations. No illnesses reported.

    Product
    Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88214 5, NDC 70722-232-02; b) 4OZ (113G) glass jar, UPC Code 6 73673 88804 8, NDC 70722-232-04; Little Moon Essentials LLC Dania Beach, Fl 33004
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2024·2024-07-10

    Prucka 3 Amplifier capacitors could fail during cardiac monitoring procedures

    Capacitors in Prucka 3 Amplifiers used with CardioLab and ComboLab cardiac systems could fail, causing display oscillations and preventing visualization of heart electrical activity waveforms.

    Product
    Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodynamic and electrophysiology recording system; and Field Replacement Units spare part #5875569 (Assy CLABIII AMP 128CH 100-240V 50-60HZ).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1456-2024·2024-07-10

    Lactose Powder Recalled Due to Potential Salmonella Contamination

    Grande Ingredients has recalled lactose and lactose powder products due to potential Salmonella contamination. No illnesses have been reported.

    Product
    Drug Emporium Yogurt Flavored Pretzels, 8oz (227g) , GNS Foods, Arlington, TX 76011
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2264-2024·2024-07-10

    Immunoassay Analyzer Software Defect May Cause Incorrect Test Calibration

    Beckman Coulter is recalling 116 DxI 9000 Immunoassay Analyzers due to a software defect that fails to properly validate calibrator barcodes, potentially resulting in incorrect calibration curves and erroneous patient test results.

    Product
    DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2226-2024·2024-07-10

    Medline Neuro IR Surgical Kit Recalled Due to Weak Seals

    Medline is recalling Neuro IR surgical convenience kits due to weak seals in the Pure Pouch component that may compromise sterility. The recall affects 12,588 kits distributed nationwide.

    Product
    Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2262-2024·2024-07-10

    BD Alaris System Manager Software Connectivity Issue Recalled Nationwide

    A software issue in BD Alaris System Manager version 12.5.1 may prevent the PC unit from connecting to the server, potentially affecting wireless data transmission. CareFusion 303, Inc. is recalling the affected software version nationwide.

    Product
    BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1471-2024·2024-07-10

    Ice Cream Recall: Foreign Rubber Found in Cookie Dough Product

    Casper's Ice Cream recalls Red Button Vintage Creamery Cookie Dough Ice Cream due to rubber pieces found in two tubs. The product was distributed across eight western states.

    Product
    Red Button Vintage Creamery Cookie Dough Ice Cream, Net weight 1.75 qt (1.66 L).
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2256-2024·2024-07-10

    BD Pyxis automated dispensing cabinets with noncertified power strips

    BD Pyxis automated dispensing cabinets were shipped with socket-outlet power strips that lack IEC electrical certification, potentially exposing users to leakage currents and electric shock.

    Product
    BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 169-157, BD PYXIS MB TWR MN 1FM-10HH-1FH MP/ 169-143, BD PYXIS MB TWR MN 2FH-1FM-4HH-2FM MP/ 169-145, BD PYXIS MB TWR MN 2FM-8HH-1FH MP/ 169-144, BD PYXIS MB TWR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2263-2024·2024-07-10

    Zyno Medical Z800 Series Infusion Pumps: Faulty Power Supply May Prevent Battery Charging

    Certain Zyno Medical Z800 series infusion pumps contain faulty power supply modules that cannot charge the rechargeable battery. When unplugged from AC power, affected pumps may lack sufficient charge to operate.

    Product
    Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2227-2024·2024-07-10

    Medline Birthing Room Pack surgical kits recalled due to weak sterile seals

    Medline is recalling approximately 12,588 sterile surgical kits used for childbirth procedures because weak seals on Pure Pouch components may fail and compromise sterility.

    Product
    Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure Pouch component Sterile Sharp/Blunt Scissors 5.5", Reorder #65945 and containing a Pure Pouch component Sterile 5.5" Episiotomy Scissors, Reorder #67645.
    Category
    Medical Device
    Distribution
    Distributed nationwide