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.

9801–9825 of 88183

  • SevereFDA (Devices)·Z-0667-2025·2024-12-25

    Draeger Atlan A300 anesthesia workstation ventilator failure FDA Class I recall

    Draeger Atlan A300 anesthesia workstations can fail to ventilate properly before or during use. The FDA classified this as Class I due to the critical risk to patient ventilation.

    Product
    Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0374-2025·2024-12-25

    Cucumber Products Recalled Due to Potential Salmonella Contamination

    Indianapolis Fruit Company is recalling 288 cases of cucumber products distributed to Indiana, Kentucky, Ohio, and Pennsylvania due to potential salmonella contamination.

    Product
    Cucumbers Slices 1/2 Cup, 100 cups per case, Product Code CUCS100, Item Number - 14705 Cucumbers Diced 1" Peeled 5 lb. tray, 2 trays per case, Product Code CUDN45L, Item Number - 9975 Cucumbers Slices 2 oz., 100 per case, Product Code CUS100, Item Number - 9816 Cucumbers…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0292-2025·2024-12-25

    Whole Foods Organic Carrots & Celery Recalled Due to E. coli O121:H19 Contamination Risk

    F&S Fresh Foods is recalling Whole Foods Market Organic Carrots & Celery due to potential E. coli O121:H19 contamination. The affected products were distributed in AZ, CA, HI, ID, and NV.

    Product
    WHOLE FOODS MARKET, Organic Carrots & Celery, NET WT. 15 oz (425 g), PERISHABLE KEEP REFRIGERATED, Packed For: Whole Foods Market Austin, TX 78703, Pre-washed and ready to eat
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0690-2025·2024-12-25

    K-Systems T47 Warming Plate May Exceed Set Temperatures

    CooperSurgical recalls K-Systems T47 Warming Plates because temperature may exceed the desired set value, potentially affecting biological materials. The device alarms appropriately when this occurs.

    Product
    Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0707-2025·2024-12-25

    Duravent Silicone Ventilation Tubes recalled for product substitution error

    Olympus is recalling 984 Duravent Silicone Ventilation Tubes (Model 240075) due to the potential that some units may contain incorrect product—specifically 1.32 mm Tiny T Tubes (Model 70240076) instead of the intended product.

    Product
    Duravent Silicone Ventilation Tube. Model Number: 240075.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Drugs)·D-0139-2025·2024-12-25

    Primo Topical Anesthetic Gel Recalled for Manufacturing Defect

    Primo Topical Anesthetic Gel (Benzocaine 20%) is recalled due to manufacturing defect. A Quality Unit inspection found scratches in the mixing vessel, causing inadvertent release of product that should have been rejected.

    Product
    Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0144-2025·2024-12-25

    Pearson Quality Topical Anesthetic Gel Recalled Due to Manufacturing Defect

    Keystone Industries is recalling Pearson Quality Topical Anesthetic Gel (20% Benzocaine) due to manufacturing equipment defects that could allow product contamination. The affected lot was inadvertently shipped despite quality control rejection.

    Product
    Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Dental Supply Inc., Sylmar, CA 91342 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0305-2025·2024-12-25

    Italian Meatball Dry Mix Recalled Due to Metal Contamination

    GRIFFITH FOODS LTD is recalling 25,903 pounds of Italian Meatball Dry Mix due to potential metal pieces in the product. The product was distributed across IL, NY, NC, WI, TX, TN, and GA.

    Product
    Item 18968101, 100138 ITALIAN MBALL DRY MIX EX, 40.84 lb. bag
    Category
    Food
    Distribution
    7 states
  • HighFDA (Drugs)·D-0152-2025·2024-12-25

    Ophthalmic solution recalled for lack of sterility assurance

    Regener-Eyes ophthalmic solution is being recalled due to lack of sterility assurance. Approximately 170,812 bottles distributed nationwide are affected.

    Product
    LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-006-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0146-2025·2024-12-25

    Quala Dental Topical Anesthetic Gel Recalled for Manufacturing Equipment Defect

    Quala Dental Products topical anesthetic gel (20% benzocaine) is recalled due to manufacturing equipment defects. The bulk product was inadvertently released despite Quality Unit rejection after inspection found scratches on the mixing vessel.

    Product
    Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for: NDC, Inc, 407 New Sanford Road, La Vergne, TN 37086, www.quala.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0304-2025·2024-12-25

    Spicy Breading Product Recalled for Potential Metal Contamination

    GRIFFITH FOODS LTD has recalled 50-pound bags of Spicy Breading Export (LOT 575830) due to potential metal contamination. Affected product was distributed to IL, NY, NC, WI, TX, TN, and GA.

    Product
    Item 42081001, 104023600 SPICY BREADING EXPORT, 50 lb. bag
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0297-2025·2024-12-25

    Bulk Candy Coated Popcorn Recalled for Undeclared Milk Allergen

    Yoder's Cashew Crunch Corn, unlabeled bulk candy coated popcorn, is being recalled because milk allergen is not declared. The product was distributed to retail and wholesale locations in Iowa and Georgia.

    Product
    Yoder's Cashew Crunch Corn, bulk candy coated popcorn packaged in clear plastic without label.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0705-2025·2024-12-25

    OEC 9900 Mobile Fluoroscopic X-Ray System Recall for Sealing Defect

    GE OEC Medical Systems is recalling 78 OEC 9900 Elite mobile fluoroscopy systems due to insufficient sealing of X-ray tubes. The defect can result in oil leaks and loss of fluoroscopic imaging capability.

    Product
    OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Drugs)·D-0153-2025·2024-12-25

    OTC Ophthalmic Solution Recalled for Lack of Sterility Assurance

    REGENER-EYES ophthalmic solution is being recalled nationwide due to lack of sterility assurance. Consumers should stop using affected lots immediately.

    Product
    PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-003-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0696-2025·2024-12-25

    ET Tube Holder Recalled for Risk of Facial Skin Injury

    Medline's HUDSON RCI mBrace ET tube holder is being recalled because its adhesive and frame design may put excessive pressure on patients' cheekbones and upper lip, potentially causing skin injury.

    Product
    HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0706-2025·2024-12-25

    GE OEC 9800 X-Ray System Recalled for Insufficient Tube Sealing

    GE OEC 9800 fluoroscopic X-ray systems are recalled due to insufficient sealing of X-ray tubes, which can result in oil leaks and loss of imaging capability. 25 systems distributed in the U.S. and internationally are affected.

    Product
    OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Food)·F-0310-2025·2024-12-25

    Bakestone Brothers Pita Bread Recalled Due to Metal Contamination

    Bakestone Brothers Pita Bread is being recalled due to the presence of metal pieces in the product. Consumers who have purchased this bread should not consume it and should discard it.

    Product
    Bakestone Brothers Pita Bread, 6 Whole Wheat Pitas. Net Wt. 11.4 oz(325g) UPC 0 57391-01002 6. Manufactured by PBF pita Bread Factory Ltd, 8000 Winston Street, Burnaby British Columbia V5A 2H5. Product of Canada
    Category
    Food
    Distribution
    5 states
  • HighFDA (Drugs)·D-0138-2025·2024-12-25

    Topical Anesthetic Gel Recalled for Manufacturing Equipment Defect

    Keystone Industries is recalling Benzocaine 20% topical anesthetic gel due to scratches in the manufacturing mixing vessel. Despite Quality Assurance rejection, the product was inadvertently shipped to customers.

    Product
    M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue, Ozone Park, NY 11416.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0697-2025·2024-12-25

    Tracheal Tube Holder Recalled for Defect Causing Potential Skin Pressure Injury

    Medline Industries is recalling 1,464 units of the HUDSON RCI mBrace tracheal tube holder due to adhesive and frame defects that may cause skin pressure injury. The device defect puts pressure on patients' cheekbones and upper lip depending on positioning.

    Product
    HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0680-2025·2024-12-25

    Laser Atherectomy Catheter Recalled for Marker Band Detachment Risk

    Spectranetics is recalling the Turbo Elite Laser Atherectomy Catheter because the marker band can detach from the catheter tip and remain in the patient. This defect was identified through customer complaints.

    Product
    Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW 423-001 / 989930000591 / 2.3 mm OTW 425-011 / 989930000601 / 2.5 mm OTW…
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Food)·F-0294-2025·2024-12-25

    Yoder's Cashew Crunch hard candy recalled for undeclared milk allergen

    Yoder's Cashew Crunch hard candy contains undeclared milk allergen. Affected packages were distributed to retail and wholesale locations in Iowa and Georgia.

    Product
    Hard candy packed in clear plastic bag with gold/red label, Yoder's Cashew Crunch, 14oz, 2620 Hwy. 22, Riverside, IA 52327
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0689-2025·2024-12-25

    K-Systems T47 Warming Plate may exceed desired temperatures

    The K-Systems T47 Warming Plate has a temperature control defect where warming surfaces may exceed desired set temperatures. CooperSurgical is recalling 22 affected units distributed to fertility clinics.

    Product
    Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0698-2025·2024-12-25

    ET Tube Holder Recalled Due to Skin Pressure Defect Risk

    Medline is recalling HUDSON RCI mBrace ET tube holders because defective adhesive and frame can cause pressure on patients' cheeks and lips, risking skin injury. The risk depends on device positioning.

    Product
    HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0703-2025·2024-12-25

    OEC 3D Mobile Fluoroscopic X-Ray System Tube Sealing Defect Recall

    GE OEC Medical Systems is recalling 84 OEC 3D mobile fluoroscopic X-ray systems due to manufacturing defects in X-ray tube sealing that can cause oil leaks and loss of imaging capability.

    Product
    OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Food)·F-0286-2025·2024-12-25

    Food-Grade Salt Products Recalled for Foreign Material Contamination

    Compass Minerals America Inc. is recalling approximately 67 metric tons of food-grade salt products due to foreign material contamination. The voluntary recall affects products distributed in Massachusetts, Indiana, Wisconsin, and Canada.

    Product
    Bulk salt product shipped in 1 metric ton tote; 50lb bag Special Purity Granulated Food-Grade Salt with UPC 041582150158; 44lb bag sifto Hy Grade Food Grade Salt, Compass Minerals America Inc. 9900 West 109th Street Overland Park, KS 99219
    Category
    Food
    Distribution
    3 states