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.

12551–12575 of 27206

  • HighFDA (Devices)·Z-1179-2024·2024-02-28

    Biliary Endoprosthesis Labeling Mismatch Risks Incorrect Device Placement

    W.L. Gore's GORE VIABIL Short Wire Biliary Endoprosthesis may be mislabeled regarding drainage holes, risking extended procedures, infections, and unplanned device removal in 24 units distributed in Georgia.

    Product
    GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1177-2024·2024-02-28

    Azurion 5 X-Ray System Generator May Fail Due to Circuit Short

    Philips Azurion 5 X-ray systems with Certeray generators may experience power loss due to a potential short circuit in the power inverter board, potentially delaying or interrupting medical procedures.

    Product
    Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0326-2024·2024-02-28

    Fluticasone Propionate Nasal Spray Recalled for Potential Bacterial Contamination

    Apotex Corp. is recalling Fluticasone Propionate Nasal Spray (292,752 bottles nationwide) due to potential Burkholderia cepacia contamination from manufacturing deviations. No illnesses reported.

    Product
    FLUTICASONE PROPIONATE — FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0888-2024·2024-02-28

    Spring Flour Recalled for Potential Metal and Wood Contamination

    Mennel Milling Company is recalling R01001 ENR SPRING FLR flour due to potential contamination with metal, wood, gasket material, and sifter balls. Consumers should not use affected product.

    Product
    R01001 ENR SPRING FLR delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0884-2024·2024-02-28

    Bread Flour Recalled for Potential Foreign Material Contamination

    Mennel Milling Company is recalling bulk bread flour due to potential contamination with metal, wood, gasket material, and sifter balls. The flour was distributed to bakeries and food manufacturers in six states.

    Product
    BREAD FLOUR UNBL ENR delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0890-2024·2024-02-28

    Malted Flour Recalled for Potential Foreign Material Contamination

    Mennel Milling Company recalls UNBLE ENR MALTED RM6144 FLOUR for potential foreign material contamination including metal, wood, gasket material, and sifter balls. The recall affects approximately 2.6 million pounds distributed in six states.

    Product
    UNBLE ENR MALTED RM6144 FLOUR delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1167-2024·2024-02-28

    ESG Cutting Forceps Jaw May Fracture During Use or Inspection

    Olympus Corporation of the Americas is recalling ESG PK Cutting Forceps because the jaw may fracture during pre-procedure inspection or during the procedure, posing a potential injury risk.

    Product
    ESG PK CUTTING FORCEPS, 5MM, 33CM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0878-2024·2024-02-28

    Donut Cake Flour Recalled for Potential Metal and Foreign Material Contamination

    Mennel Milling Company is recalling donut cake flour products due to potential contamination with metal, wood, gasket material, and sifter balls. The affected product was distributed across six states; no illnesses have been reported.

    Product
    1002560 DONUT CAKE FLR delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0877-2024·2024-02-28

    Mennel Milling White Flour Recalled for Potential Foreign Material

    Mennel Milling Company is recalling white flour delivered as bulk product due to potential contamination with metal, wood, gasket material, and sifter balls. The recall affects approximately 2.6 million pounds distributed across six states.

    Product
    1000000 White Flour UNBL EN MT delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1142-2024·2024-02-28

    Dental cement capsules recalled due to manufacturing defect affecting curing

    IonoStar Plus dental cement capsules contain an incorrect plunger due to a manufacturing error. The defect prevents proper curing of the cement, making the product unsuitable for use.

    Product
    IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-0883-2024·2024-02-28

    Bagel Flour Recalled Due to Potential Foreign Material Contamination

    Mennel Milling Company is recalling approximately 2.6 million pounds of bagel flour distributed in six states due to potential contamination with metal, wood, gasket material, and sifter balls.

    Product
    BAGEL FLOUR delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Drugs)·D-0331-2024·2024-02-28

    Cough drops recalled for potential glass and silicone contamination

    Bestco LLC is recalling Family Wellness Cherry Cough Drops nationwide due to potential glass and silicone particulates found during manufacturing. Consumers should stop use immediately.

    Product
    Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1181-2024·2024-02-28

    Radiation Oncology Treatment Planning Software VERIQA Calculation Error

    PTW-FREIBURG's VERIQA software (versions 2.0 and 2.1) may incorrectly calculate gamma passing rates when users exclude voxels below a dose threshold, potentially displaying false positive dose evaluation results.

    Product
    Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0908-2024·2024-02-28

    Spice product recalled for undeclared wheat allergen

    Vandevi Compounded Asafoetida spice is recalled due to undeclared wheat. Consumers with wheat allergies should not use this product.

    Product
    Vandevi Compounded Asafoetida 50 gm, 100 gms 200 gm, 500 gm, 1 kg. Packaged in yellow plastic bottles with plastic shrink wrap blue/yellow labels.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1145-2024·2024-02-28

    Philips Azurion Interventional X-ray Systems framegrabber card may fail to display images

    The framegrabber card in Philips Azurion interventional X-ray systems may fail to display diagnostic images properly, potentially delaying procedures.

    Product
    Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722067; Azurion 7 B20 722068; Azurion 7 M12 722078 722223;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1148-2024·2024-02-28

    Patterson Procedure Earloop Masks Recalled Due to Non-Validated Production Equipment

    Patterson Procedure Earloop Masks (ASTM Level 3, blue) are being recalled because units were produced on non-validated equipment. The recall affects 180 cases with lot numbers 2339 and 2342, distributed across six states.

    Product
    PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1173-2024·2024-02-28

    OPTIMIZER CCM X11 Implantable Pulse Generator May Fail to Deliver Therapy

    The OPTIMIZER model CCM X11 implantable pulse generator may incorrectly detect a charging error and cease delivering cardiac therapy, potentially causing patients to experience heart failure symptoms. A total of 1,469 units are affected.

    Product
    OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0905-2024·2024-02-28

    Fortune Cookies Recalled Due to Undeclared Soy Allergen

    Fortune cookies from New World Company are recalled for containing undeclared soy allergen. The 1 lb retail bags were distributed in California to consumers.

    Product
    Fortune cookies, 1 lb plastic retail bags
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0901-2024·2024-02-28

    Animal feed recalled for potential foreign material contamination

    Mennel Milling Company recalled PB AP bulk animal feed due to potential contamination with metal, wood, gasket material, and sifter balls. Approximately 2.6 million pounds of affected product was distributed across six states.

    Product
    PB AP delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1172-2024·2024-02-28

    Synapse CV 6 Imaging Software Calculation Error May Cause Misdiagnosis

    FUJIFILM Synapse CV 6 medical imaging software may incorrectly calculate left ventricle mass measurements. If used for diagnosis, this calculation error could lead to patient misdiagnosis and incorrect treatment, potentially causing long-term health consequences.

    Product
    Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0895-2024·2024-02-28

    FDA Recalls Bulk Milling Product for Potential Foreign Material

    Mennel Milling Company is recalling its milling product (2-15969-0000) due to potential contamination with metal, wood, gasket material, and sifter balls. The product was distributed across Kentucky, Michigan, New Jersey, New York, Ohio, and Pennsylvania.

    Product
    2-15969-0000 delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0899-2024·2024-02-28

    Mennel Milling I-52 Patent Flour Recalled for Foreign Material Contamination

    Mennel Milling Company recalled I-52 Patent Flour containing potential foreign material including metal, wood, gasket material, and sifter balls. The flour was distributed in bulk trailers across six states.

    Product
    I-52 PATENT FLOUR delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Drugs)·D-0337-2024·2024-02-28

    Voriconazole Oral Suspension Recalled for Missing Package Insert

    Lupin Pharmaceuticals recalls Voriconazole for Oral Suspension (40mg/mL) due to missing or incorrect package inserts on affected batches distributed in Ohio, Illinois, and New Jersey.

    Product
    VORICONAZOLE — VORICONAZOLE (VORICONAZOLE)
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-1176-2024·2024-02-28

    Philips Azurion 3 Surgical Imaging System Recalled for Power Failure Risk

    Philips is recalling 14 units of its Azurion 3 surgical imaging system due to a potential short circuit in the power inverter. The defect could cause the device to lose power and fail during surgical procedures.

    Product
    Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280
    Category
    Medical Device
    Distribution
    Distributed nationwide