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.

7901–7925 of 26961

  • 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 (Devices)·Z-0668-2025·2024-12-25

    FDA Recalls Draeger Atlan A300XL Anesthesia Workstation for Ventilator Failure

    Draeger Medical recalls the Atlan A300XL anesthesia workstation for potential piston ventilator failure that could occur before use or during anesthesia delivery. Twenty-five units were distributed outside the United States.

    Product
    Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0661-2025·2024-12-25

    Medtronic Becker Neurosurgical Drainage Systems Recalled for Cracked and Leaking Stopcocks

    Medtronic Neurosurgery recalls Becker External Drainage and Monitoring Systems due to reports of cracks and leaks in stopcocks. The recalled systems are used to drain cerebrospinal fluid and monitor pressure in neurosurgery patients.

    Product
    Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE 27670 BECKER 27670 STOP BELOW DC NDL-LS IN 27672 BECKER 27672 ONEWAY VLV Y-SI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0302-2025·2024-12-25

    Baker Farms Curly Mustard Recalled for Listeria Contamination

    Baker Farms Curly Mustard 16 oz bags are being recalled due to contamination with Listeria monocytogenes. The product was distributed to distribution centers in nine states.

    Product
    Baker Farms CURLY MUSTARD 16 oz NET WT 16 oz UPC 8 13098 02018 4 Baker Farms 3667 Ellenton-Norman Park Road Norman Park, GA 31771
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0290-2025·2024-12-25

    Carrot falafel product recalled for potential E. coli contamination

    Fabalish Inc.'s Kickin brand carrot falafel is being recalled due to potential E. coli contamination. Consumers should not consume the product.

    Product
    Fabalish Inc. , Kickin, Carrot Falafel , 10oz , Cardboard tray inside plastic film inside cardboard box, individual units
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Devices)·Z-0658-2025·2024-12-25

    Walcott Bipolar Pencil Surgical Instrument Recalled for Potential Tube Detachment

    Kirwan Surgical Products is recalling Walcott Bipolar Pencil 25 Gauge surgical instruments due to potential breakage or detachment of the stainless-steel tube. The affected pencils are used in eye and soft tissue surgery.

    Product
    Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the re
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0301-2025·2024-12-25

    Artisan Multigrain Baguettes Recalled for Possible Metal Contamination

    Stuyvers Bread is recalling Artisan Multigrain Baguettes (Lot #24313) due to possible metal contamination in a sub-ingredient. The product was distributed to two consignees in California, Connecticut, and Washington.

    Product
    Baguette, Artisan Multigrain. (30 Units/box) 400g/each. Contains: Wheat, Sesame Seeds, Gluten (rye, barley, oat) Lot#24313
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0296-2025·2024-12-25

    Candy coated popcorn recalled for undeclared milk allergen

    Yoder's Cashew Crunch candy coated popcorn is recalled due to undeclared milk allergen on package labels. 319 packages were distributed to retail and wholesale locations in Iowa and Georgia.

    Product
    Candy coated popcorn packaged in clear plastic with gold label, 7 oz, Yoders Cashew Crunch Corn, 2620 Hwy. 22, Riverside, IA 52327
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0695-2025·2024-12-25

    HUDSON RCI mBrace ET Tube Holder Risks Facial Dermal Injury

    Medline is recalling the HUDSON RCI mBrace ET tube holder because defective adhesive and frame elements may cause pressure and skin injury to the face.

    Product
    HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0687-2025·2024-12-25

    K-Systems G73 Dry Bath Incubator may exceed target temperature

    CooperSurgical is recalling K-Systems G73 Dry Bath Incubators because warming surfaces may exceed the desired set temperature. The device alarms when this occurs.

    Product
    Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at c
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-0295-2025·2024-12-25

    Yoder's Cashew Crunch Hard Candy Recalled for Undeclared Milk Allergen

    Yoder's Cashew Crunch hard candy is being recalled for undeclared milk allergen. The product was distributed in Iowa and Georgia to retail and wholesale customers.

    Product
    Yoder's Cashew Crunch, hard candy shipped in bulk in clear plastic bag.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0710-2025·2024-12-25

    Medical imaging software recall for incorrect DICOM orientation labels

    Mint Lesion software versions 3.10.0 and 3.10.1 may display incorrect orientation labels for certain DICOM medical images. The defect affects 18 units distributed across the US and internationally.

    Product
    mint Lesion, Software Versions: 3.10.0 and 3.10.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0142-2025·2024-12-25

    FDA Recalls Health-Tec Benzocaine Topical Anesthetic Due to Manufacturing Defect

    Keystone Industries recalls Health-Tec Topical Anesthetic (Benzocaine 20%) lot BNZ-001646 due to manufacturing defects. Scratches found in the mixing vessel caused product rejection designation, but product was inadvertently shipped.

    Product
    HEALTH-TEC TOPICAL ANESTHETIC — HEALTH-TEC TOPICAL ANESTHETIC (BENZOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0704-2025·2024-12-25

    Fluoroscopic X-Ray System Recalled for Insufficient X-Ray Tube Sealing

    GE OEC Elite mobile fluoroscopic X-ray systems are recalled due to insufficient sealing of X-ray tubes, which can cause oil leaks and loss of imaging capability. Approximately 100 systems have been affected.

    Product
    OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Food)·F-0308-2025·2024-12-25

    Bulk Food Ingredient Recalled for Potential Metal Contamination

    Griffith Foods Ltd recalls bulk food ingredient Item 16354301 due to potential metal contamination. Product was distributed to food service facilities in Illinois, New York, North Carolina, Wisconsin, Texas, Tennessee, and Georgia.

    Product
    Item 16354301, MAXI - 44067705 - MAXI KR BA BA 3040 EX, 55.115 lb. bag
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0284-2025·2024-12-25

    Impossible Savory Ground Sausage Recalled Due to Potential Metal Contamination

    Impossible Foods is recalling Impossible Savory Ground Sausage nationwide due to potential metal contamination. Consumers should not consume affected products and should return them to their retailer.

    Product
    Impossible Savory Ground Sausage Meat from plants 14oz chub, UPC 8 16697 02108 8; 8 retail chubs per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0300-2025·2024-12-25

    Pull-Apart Holiday Rolls Recalled for Possible Metal Contamination

    Stuyvers Bread is recalling Pull-Apart Holiday Rolls due to possible metal contamination in a sub-ingredient. The affected product was distributed to select retailers in California, Connecticut, and Washington.

    Product
    Pull apart Holiday Rolls (cluster bun). (2 Units/bag) 195g/each. Contains: Wheat, Milk Lot#24312
    Category
    Food
    Distribution
    0 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
  • HighFDA (Food)·F-0298-2025·2024-12-25

    Frozen Salmon Products Recalled Due to Listeria Risk

    Ocean Group Inc. is recalling multiple frozen salmon products sold in California due to potential Listeria monocytogenes contamination detected in environmental samples at the production facility.

    Product
    SALMON BAKKAFROST FAROE ISLANDS 5/6KG FR FRO F LB SALMON NORWAY 6/7KG FR NOR F LB SALMON BAKKAFROST FAROE ISLANDS 6/7KG FR FRO F LB SALMON HIDDENFJORD FAROE ISLANDS 6/7KG FR F LB SALMON BAKKAFROST FAROE ISLANDS 7/8KG FR FRO F LB SALMON HIDDENFJORD FAROE ISLANDS 7/8KG FR F LB SALM
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0702-2025·2024-12-25

    Hillrom Temperature Management Controller Power-On Self-Test Error Code Update

    Augustine Temperature Management recalled Hillrom Temperature Management Controllers (Models WC71, WC77, and MP 2083516) due to power-on self-test error code EA POST. No injuries or illnesses reported.

    Product
    Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0311-2025·2024-12-25

    L'Oven Fresh KETO Tortilla Wraps recalled for possible metal contamination

    Rise Baking Company is recalling L'Oven Fresh KETO Friendly Original 6 Tortilla Wraps sold at Aldi stores in five states due to potential metal contamination. Affected products carry specific Julian date codes from 24 302 to 24 311.

    Product
    L'Oven Fresh KETO Friendly Original 6 Tortilla Wraps. Net Wt. 7.8 oz(222g) UPC 4099100271348. Dist & Sold Exclusively By: Aldi, Batavia, IL 60510. Product of Canada
    Category
    Food
    Distribution
    5 states
  • 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 (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-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-0657-2025·2024-12-25

    Ambler Surgical Bipolar Pencil recalled for outer tube structural failure

    Kirwan Surgical Products is recalling the Ambler Surgical Bipolar Pencil 25 Gauge Straight (Model PD7226) because the outer stainless-steel tube may break or detach during use. 4,470 units worldwide are affected.

    Product
    Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area durin
    Category
    Medical Device
    Distribution
    Distributed nationwide