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.

12626–12650 of 27206

  • SevereFDA (Food)·F-0875-2024·2024-02-21

    Fresh Express Chopped Salad Kit Southwest Recalled for Listeria Risk

    Fresh Express Incorporated is recalling Chopped Salad Kit Southwest products due to potential Listeria monocytogenes contamination in the cheese condiment pack. Consumers should not consume the product.

    Product
    Chopped Salad Kit Southwest with condiments(toppings that include cheese), labeled salad bag (Green Cabbage, Green Leaf Lettuce, Kale, Red Cabbage, Carrots, Green Onions, Tortilla Strips, Cheddar Cheese, and Chipotle Ranch Dressing), Net Wt 13.4 oz, 6 bags per case. UPC 681131305
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0961-2024·2024-02-21

    GE Healthcare Incubators Bedside Panel Latch Failure Poses Fall Risk

    GE Healthcare incubators have defective bedside panels that may appear closed but not be properly latched, creating a patient fall risk when the panels disengage upon impact.

    Product
    GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0958-2024·2024-02-21

    GE Healthcare Care Plus and Lullaby incubators recalled for bedside panel latching defect

    GE Healthcare is recalling 1,410 neonatal incubators worldwide because bedside panels and portholes can appear closed while not properly latched. If impacted, they may fall open and fail to protect patients from falls.

    Product
    GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0866-2024·2024-02-21

    Utz Wavy Originals Potato Chips recalled for undeclared milk allergen

    Utz Wavy Originals Potato Chips (2.75 oz) distributed in New York may contain undeclared milk and could pose a risk to people with milk allergies.

    Product
    Utz Wavy Originals Potato Chips, Net WT. 2.75 oz (78g), UPC 0-41780-19014-7.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0980-2024·2024-02-21

    Impella Cardiac Support Catheters: Risk of Left Ventricle Perforation

    Impella cardiac catheters are being recalled due to risk of left ventricle perforation during operator use. The FDA has classified this Class I recall affecting 91,914 units worldwide.

    Product
    Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 wit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0868-2024·2024-02-21

    Al Amir Fresh Foods Hummus recalled for undeclared sesame allergen

    Al Amir Fresh Foods Harissa Spicy Hummus With a Kick is being recalled due to an undeclared sesame allergen. The product declares tahini but not sesame, which could cause serious allergic reactions in people with sesame sensitivity.

    Product
    Al Amir Fresh Foods Harissa Spicy Hummus With a Kick, packaged in round plastic clear container, net wt. 8oz. There are 12 containers per case. UPC on 8oz container: 7 55134 12352 0. The recalled product label declares: Ingredients: Garbanzo Beans, Tahini Paste, Garlico (Fresh G
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0865-2024·2024-02-21

    Dragonfly Jelly Bar Handbags and Backpacks Recalled for Choking Hazard

    U.S. Tov, Inc. is recalling Dragonfly Jelly Bar Handbags and Backpacks due to a potential choking hazard from konjac. The products were distributed nationwide.

    Product
    Dragonfly Jelly Bar Handbag 11.64oz, 17.63oz UPC Code 721557357156, 721557357163 Dragonfly Jelly Bar Backpack 7.93oz, 28.22oz UPC Code 721557357170, 721557357187
    Category
    Food
    Distribution
    38 states
  • SevereFDA (Food)·F-0876-2024·2024-02-21

    Fresh Express Salad Kit Recalled for Potential Listeria Contamination

    Fresh Express Kit Salsa! Ensalada salad kits are recalled for potential Listeria monocytogenes contamination in the cheese condiment. The affected 12.1 oz bags were distributed to AL, FL, GA, CA, UT, WA, and Canada.

    Product
    Fresh Express Kit Salsa! Ensalada with condiments(toppings that include cheese), labeled salad bag (Iceberg & Romaine Lettuce, Salsa Ranch Dressing, Nacho Taco Seasoned Cheese Yellow & Blue Tortilla Strips), Net Wt 12.1 oz, 6 bags per case. UPC 071279309026
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0867-2024·2024-02-21

    Al Amir Fresh Foods Hummus Recalled for Undeclared Sesame Allergen

    Al Amir Fresh Foods Classic Hummus Creamy Garbanzo is recalled because it contains sesame (tahini) but the label does not declare sesame as an allergen. Consumers with sesame allergies may experience allergic reactions.

    Product
    Al Amir Fresh Foods Classic Hummus Creamy Garbanzo, packaged in round plastic clear container, net wt. 8oz. There are 12 containers per case. UPC on 8oz container: 7 55134 12341 4. The recalled product label declares: Ingredients: Garbanzo Beans, Tahini Paste, Garlico (Fresh G
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0874-2024·2024-02-21

    Mighty Fine Chocolate Ice Cream Recalled for Undeclared Peanuts

    Byrne Dairy, Inc is recalling Mighty Fine Chocolate Ice Cream because it contains undeclared peanuts. Consumers with peanut allergies should not consume this product.

    Product
    Mighty Fine Chocolate Ice Cream
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1066-2024·2024-02-21

    Bone Filler Tubes Recalled Due to Manufacturing Process Defect

    The FDA is recalling 89 AFT Bone Filler Tubes due to a manufacturing process defect that could cause extrudability issues during surgery. The filling process did not demonstrate adequate capability.

    Product
    AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1077-2024·2024-02-21

    Medical Device Recall: Heart-Lung Machine Component Sterile Barrier Defect

    The BEQ-HLS 7050 USA HLS Set Advanced 7.0 is recalled due to a compromised sterile barrier on its Emergency Priming Line component. This defect may cause inflammation, sepsis, or infection.

    Product
    BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0872-2024·2024-02-21

    Woodstock 5 Grain Cereal recalled for undisclosed wheat allergen

    Woodstock 5 Grain Cereal is recalled because triticale, a product ingredient, is not identified as wheat on the label. This creates a risk for people with wheat allergies.

    Product
    Woodstock 5 Grain Cereal. Oats, Rye, Triticale, Barley, Golden Flax. Net Wt. 18.5 oz (1 lb 2.5 oz) 524g. UPC 0 42563-01772 9. Distributed by Woodstock, 313 Iron Horse Way, Providence, RI 02908. Packaged in a plant that also processes wheat.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2024·2024-02-21

    Portable X-ray system may move unexpectedly if improperly cleaned

    The MobileDiagnost wDR portable X-ray system may move unexpectedly if excessive liquid is used during cleaning. This affects 851 devices distributed nationwide.

    Product
    MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1069-2024·2024-02-21

    Captus 4000e Thyroid Uptake Systems spring failure poses fall risk

    Mirion Technologies recalls 467 Captus 4000e Thyroid Uptake Systems due to spring arm failure that can cause the collimator to fall, posing potential injury risk to patients and operators.

    Product
    Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures. Models: 5430-30151, 5430-30152, and 5430-30154
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1087-2024·2024-02-21

    Philips CombiDiagnost R90 Fluoroscopy Device May Display Wrong Patient Images

    The Philips CombiDiagnost R90 fluoroscopy device may display a previous patient's radiography images during an examination, risking privacy violation and diagnostic errors in 86 affected units.

    Product
    CombiDiagnost R90 1.0 (709030)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1085-2024·2024-02-21

    Stryker Trevo Trak 21 Microcatheter Recalled for Unevaluated Intended Use

    Stryker, Inc. is recalling 63 units of the Trevo Trak 21 Microcatheter because the device instructions contain an intended use that has not been evaluated by the FDA.

    Product
    Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1072-2024·2024-02-21

    Philips ProxiDiagnost N90 X-ray System Recall for Patient Data and Security Issues

    Philips is recalling 138 U.S. units of its ProxiDiagnost N90 radiography system due to two identified issues. The system may display incorrect patient images during scan transitions, and a security vulnerability could allow unauthorized data access with physical device access.

    Product
    ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0325-2024·2024-02-21

    Vasopressin Compounded Injectable Syringes Recalled for Sub-Potency Failure

    IntegraDose Compounding Services is recalling Vasopressin injectable syringes because the medication may lose potency before its labeled expiration date, potentially leaving patients with reduced doses.

    Product
    Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1078-2024·2024-02-21

    Skin Graft Carrier Recalled for Manufacturing Ratio Defect

    Zimmer Surgical Inc. is recalling 3:1 Dermacarrier skin graft carriers due to a manufacturing defect where the ridge pattern is 1.5:1 instead of 3:1, potentially causing tissue damage or additional grafting.

    Product
    3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1089-2024·2024-02-21

    global Medium embryo culture media recalled for potential development impairment

    CooperSurgical is recalling three specific lots of global Medium embryo culture media distributed to fertility clinics worldwide due to performance issues that may impair embryo development during culture.

    Product
    global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1140-2024·2024-02-21

    FilmArray GI diagnostic kits recalled due to false positive Norovirus results

    BioFire Diagnostics is recalling FilmArray GI diagnostic test kits due to potential signals of increased false positive Norovirus results. Approximately 64,594 kits representing 2.3 million tests have been distributed worldwide.

    Product
    FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0871-2024·2024-02-21

    Dannon Plain Yogurt 32oz cartons recalled for potential sanitizer contamination

    DANONE US LLC is recalling Dannon Plain Yogurt 32oz cartons distributed in Georgia due to potential contamination with sanitizer. The affected product expires 03/13/24.

    Product
    Dannon Plain Yogurt packaged in 32oz plastic carton with lid - 6 cartons per case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1056-2024·2024-02-21

    Samsung GM85 Mobile X-ray System Welding Frame Defect Arm Fall Risk

    NeuroLogica is recalling 261 Samsung GM85 mobile x-ray systems due to a welding defect in the moving arm frame that could cause the arm to fall, risking bodily injury.

    Product
    Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1088-2024·2024-02-21

    Philips CombiDiagnost R90 Fluoroscopy Display May Show Previous Patient Images

    Philips CombiDiagnost R90 fluoroscopy systems may display a previous patient's images during radiography examination, potentially showing different image content, format, and size that could affect imaging accuracy.

    Product
    CombiDiagnost R90 1.1 (709031)
    Category
    Medical Device
    Distribution
    Distributed nationwide