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.

19001–19025 of 88183

  • HighFDA (Devices)·Z-1574-2023·2023-05-17

    Medtronic Spinal Distractor Rack Recalled for Manufacturing Defect

    Medtronic is recalling Distractor Rack devices used in spinal surgery due to manufacturing defects that may prevent proper device operation. Two lot numbers are affected and were distributed to facilities in Indiana, Connecticut, and Nebraska.

    Product
    Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0872-2023·2023-05-17

    Mini Pound Cake Recalled for Undeclared Coconut Allergen

    Saint Lavian mini pound cake chocolate is being recalled because coconut is not listed on the ingredients label. Consumers with coconut allergies are at risk.

    Product
    Saint Lavian mini pound cake chocolate 2 pieces UPC: 4973341408841
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0882-2023·2023-05-17

    Smoked Wahoo Dip Recalled Due to Undeclared Yellow #5 Allergen

    Borris Brothers is recalling Smoked Wahoo Dip due to undeclared Yellow #5 (tartrazine), an allergen that may affect consumers with sensitivity. The recall affects 112 containers distributed in Florida.

    Product
    Smoked Wahoo Dip, Net Wt. 8oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0875-2023·2023-05-17

    Kajitani Food Cigar Fry Recalled for Unlabeled Coconut

    Kajitani food cigar fry (110g, UPC 4901332108289) contains coconut that is not declared on the label. The undeclared allergen poses a health risk to consumers with coconut allergies.

    Product
    Kajitani food cigar fry 110g UPC: 4901332108289
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0861-2023·2023-05-17

    Ajikal Kotsubukko Snack Recalled for Undeclared Coconut

    Ajikal 44g Kotsubukko snacks containing undeclared coconut were distributed across multiple US states and Canada. Consumers with a coconut allergy should not consume this product.

    Product
    Ajikal 44g Kotsubukko 4 series UPC: 4510656600708
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1569-2023·2023-05-17

    Aesculap Caiman Articulating Surgical Device Recalled for Loose Spring

    Aesculap Caiman Articulating electrosurgical devices are being recalled because a spring may become loose and fall out during surgery, potentially entering the patient's body.

    Product
    Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery. Product Code: PL771SU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0880-2023·2023-05-17

    Fujiya Country Ma'am Snacks Recalled for Undisclosed Peanut Allergen

    Daiso California Warehouse is recalling Fujiya Country Ma'am Vanilla & Cocoa wafers because they contain peanut (sheanut) that is not declared on the label. Consumers with peanut allergies should not consume this product.

    Product
    Fujiya Country Ma'am Vanilla & Cocoa 19 sheets UPC: 4902555272641
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0857-2023·2023-05-17

    Raspberry Products Recalled for Undeclared Soy, Milk, and Tree Nut Allergens

    Windy Hill Chocolate LLC is recalling raspberry products due to undeclared soy, milk, and tree nut allergens. Products with batch number 0120230121 and expiration date 4/12/23 may contain these allergens not listed on packaging.

    Product
    Raspberry
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0867-2023·2023-05-17

    Daisho Crab Miso Soup Recalled for Missing Shrimp Allergen Warning

    Daisho crab miso soup is being recalled because the product contains shrimp but the label warns only for crab, posing a risk to consumers with shrimp allergies. Products were distributed across multiple US states and Canada.

    Product
    Daisho crab miso soup 750g UPC: 4904621043919
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0866-2023·2023-05-17

    Sardine snack product recall for incorrect allergen labeling

    DAISO CALIFORNIA WAREHOUSE is recalling Okabe Funagata grilled sardine 43g due to incorrect allergen warning information on the package label.

    Product
    Okabe Funagata small grilled small sardine 43g UPC: 4971455077236
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0863-2023·2023-05-17

    Dried squid snack recalled for undeclared fish allergen

    DAISO dried squid snack recalled because fish other than squid is present but not listed in ingredients or allergen statement. Consumers with fish allergies are at risk.

    Product
    Pacifier dried squid cut sea urchin soy sauce flavor 20g UPC: 4904523229343
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0844-2023·2023-05-17

    Caramel Rum Truffle Recalled for Undeclared Soy, Milk, and Tree Nut Allergens

    Windy Hill Chocolate LLC is recalling Caramel Rum Truffle candies (Batch #1023220097) for undeclared soy, milk, and tree nut allergens. Affected consumers should not consume the product if they have allergies to these ingredients.

    Product
    Caramel Rum Truffle
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0822-2023·2023-05-17

    Dr. Rico Perez Super Kids Colostrum Dietary Supplement Recalled for Undeclared Milk Allergen

    Dr. Rico Perez Super Kids Colostrum chewable tablets are being recalled because the product contains milk but does not declare this allergen on the label. Consumers with milk allergies may be at risk.

    Product
    Dr. Rico Perez Super Kids Colostrum, 60 count chewable tablets dietary supplement, Supplement Facts: 200 mg Colostrum per 1 tablet. HDPE bottle. UPC 8 79840 00044 6. Mfg For: Rico Perez Prod., In2295 Coral Way, Miami, FL 33145.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0883-2023·2023-05-17

    Smoked Swordfish Dip Recalled for Undeclared Yellow #5 Color Additive

    Borris Brothers voluntarily recalls 55 containers of Smoked Swordfish Dip (8oz) distributed in Florida due to undeclared Yellow #5, a color additive that can trigger reactions in sensitive individuals.

    Product
    Smoked Swordfish Dip, Net Wt. 8oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0865-2023·2023-05-17

    Mangetsu Ebisen Crackers Recalled for Undeclared Krill Allergen

    Mangetsu Ebisen 54g crackers are recalled because krill is present in the product but not listed in the ingredients statement, only in a general shellfish warning.

    Product
    Mangetsu Ebisen 54g UPC: 4901053011370
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0846-2023·2023-05-17

    Coffee Bonbon with Undeclared Soy, Milk, and Tree Nut Allergens Recalled

    Windy Hill Chocolate LLC is recalling Coffee Bonbon products due to undeclared allergens including soy, milk, and tree nuts. These allergens are not declared on the product label, posing a risk to consumers with allergies.

    Product
    Coffee Bonbon
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1571-2023·2023-05-17

    PDS Plus Antibacterial Suture Potential Breakage During Intraoperative Use

    Ethicon recalled 1,656 units of PDS Plus Antibacterial Suture due to potential breakage during surgery, which could compromise tissue approximation. The affected lot was distributed to the United Kingdom, Ireland, and Turkey.

    Product
    PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0879-2023·2023-05-17

    Kurata Foods Vegetable Potage V Ramen recalled for unlisted coconut allergen

    DAISO CALIFORNIA WAREHOUSE is recalling Kurata Foods Vegetable Potage V Ramen because coconut was not listed in the ingredients or allergen statement. The product was distributed across multiple U.S. states and British Columbia Canada.

    Product
    Kurata Foods Vegetable Potage V Ramen 2 servings UPC: 4906436005304
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1573-2023·2023-05-17

    Laboratory Management Software May Display Incorrect Slide Labels

    TDHisto/Cyto laboratory management software may display incorrect information on slide labels in specific use cases. The FDA has issued a Class II recall affecting laboratories nationwide in California.

    Product
    TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0843-2023·2023-05-17

    Bourbon Truffle recalled for undeclared soy, milk, tree nut allergens

    Windy Hill Chocolate LLC is recalling Bourbon Truffle candies due to undeclared allergens: soy, milk, and tree nuts. Consumers with allergies to these ingredients should not consume the product.

    Product
    Bourbon Truffle
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1570-2023·2023-05-17

    M-Close Kit suturing apparatus recalled due to plastic housing fracture risk

    New Wave Endo-Surgical is recalling the M-Close Kit surgical suturing apparatus because the plastic housing may fracture. The recall affects 295 units distributed in Florida, Massachusetts, and Georgia.

    Product
    M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
    Category
    Medical Device
    Distribution
    Distributed nationwide