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.

19451–19475 of 88183

  • SevereFDA (Food)·F-0686-2023·2023-04-05

    ISH Shrimpish Sample Meal Kit Recalled for Undeclared Soy Protein

    THE ISH COMPANY is recalling 355 ISH Shrimpish Sample Meal Kits distributed to multiple states throughout 2022 for undeclared soy protein that may cause allergic reactions in sensitive consumers.

    Product
    ISH Shrimpish Sample Meal Kit: ( Sample Meal Kit ) a package containing two ISH Foods plant-based Shrimpish products and several additional meal components. Each kit is shipped frozen, using styrofoam and dry ice. Affected components: ¿ Broth Plastic jar with lid ¿ XO Sauce…
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0651-2023·2023-04-05

    Enoki Mushrooms Recalled Due to Listeria monocytogenes Contamination

    SSS brand and K-Fresh branded enoki mushrooms are being recalled due to potential Listeria monocytogenes contamination. Consumers should not consume the affected product.

    Product
    SSS brand and K-Fresh branded Enoki Mushrooms Packaged in clear plastic 200g container
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0656-2023·2023-04-05

    Seasoned Radish Recall Due to Undeclared Fish and Wheat Allergens

    Lemonland Food Corp recalls Seasoned Radish (Shredded) distributed in Washington due to undeclared fish (anchovy) and wheat allergens. The product was sold in 8oz, 12oz, and 16oz containers at H-Mart, G-Mart, and M2M stores.

    Product
    Seasoned Radish (Shredded) distributed in un-labeled plastic containers 8oz, 12oz, and 16oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1315-2023·2023-04-05

    Disposable Tourniquet Cuffs Recalled Due to Pressure Failure

    Over 127,000 disposable tourniquet cuffs are being recalled because they may fail to achieve or maintain pressure during surgery due to fabric tearing or O-ring defects, risking operative bleeding and hemorrhage.

    Product
    Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235; Color Cuff Single Port, Single Bladder 34 (Purple), Quick Connect, REF…
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Food)·F-0684-2023·2023-04-05

    Canned Geisha Medium Shrimp Recalled for Leaking Containers

    Kawasho Foods USA is recalling Geisha Medium Shrimp 4 oz cans due to leaking and bulging containers. The defect may compromise food safety.

    Product
    Geisha Medium Shrimp; WT 4OZ(113g)
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-0533-2023·2023-04-05

    Dabigatran Etexilate Drug Recalled Due to N-nitroso Impurity

    Ascend Laboratories is recalling 13,560 bottles of Dabigatran Etexilate 75 mg capsules nationwide because testing detected N-nitroso-dabigatran impurity levels above acceptable limits. The issue stems from a manufacturing quality control deviation.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1292-2023·2023-04-05

    Surgical navigation system recalled for potential mechanical instability

    Brainlab AG is recalling Cirq Arm System 2.0 devices due to potential mechanical instability from manufacturing errors. Users should discontinue use and contact the manufacturer.

    Product
    Cirq Arm System 2.0
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0654-2023·2023-04-05

    Stir-Fried Anchovy recalled for undeclared wheat, soybean, fish, and sesame

    Lemonland Food Corp has recalled Stir-Fried Anchovy products distributed in Washington due to undeclared allergens: wheat, soybean, fish, and sesame. Consumers with allergies to these ingredients should not consume the product.

    Product
    Stir-Fried Anchovy distributed in un-labeled plastic containers 6oz, 8oz, and 16oz. Containers were then labeled at H-mart, G-mart, or M2M retail stores.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0677-2023·2023-04-05

    Seasoned Fish Meat Recalled for Undeclared Fish, Wheat, and Soy Allergens

    Lemonland Food Corp is recalling Seasoned Fish Meat distributed in Washington due to undeclared fish, wheat, and soy allergens that could affect consumers with these allergies.

    Product
    Seasoned Fish Meat distributed in un-labeled plastic containers 8oz. and 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0657-2023·2023-04-05

    Radish Kimchi recalled for undeclared fish and shellfish allergens

    Lemonland Food Corp has recalled Radish Kimchi distributed in Washington due to undeclared fish (anchovy, sardinella) and shrimp. Consumers with allergies to fish or shellfish should not consume this product.

    Product
    Radish Kimchi distributed in un-labeled plastic containers 16oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0676-2023·2023-04-05

    Seasoned Crab Products Recalled by Lemonland for Undeclared Allergens

    Lemonland Food Corp recalls seasoned crab sold in Washington due to undeclared allergens including crab, sesame seeds, and anchovy. Consumers with allergies to these ingredients should not consume this product.

    Product
    Seasoned Crab was distributed in un-labeled plastic containers 8oz. and 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0660-2023·2023-04-05

    Perilla Leaves in Soy Sauce Recalled for Undeclared Allergens

    Lemonland Food Corp is recalling Perilla Leaves in Soy Sauce distributed in Washington due to undeclared Wheat, Soybean, and Fish (Anchovy). The product was sold in 12oz containers at H-mart, G-mart, and M2M retail stores.

    Product
    Perilla Leaves in Soy Sauce distributed in un-labeled plastic containers 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1312-2023·2023-04-05

    Defibtech DDU-100 Lifeline AED Recalled for Untested Component Risk

    Defibtech is recalling 29 units of the DDU-100 Lifeline AED due to an untested component that could cause device failure. The affected device may not deliver therapy if a malfunction occurs.

    Product
    DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0653-2023·2023-04-05

    Seasoned Pickled Radish Recalled for Undeclared Wheat and Sesame Allergens

    Lemonland Food Corp is recalling Seasoned Pickled Radish sold in Washington due to undeclared wheat and sesame allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    Seasoned Pickled Radish distributed in un-labeled plastic containers 6oz, 8oz, 12oz, and 16oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1285-2023·2023-04-05

    Dental Implant Titanium Base Recalled for Stability and Fracture Risk

    Preat Corp is recalling Neodent GM X 6mm titanium base components due to a dimensional defect causing vertical movement. This instability may lead to abutment fracture and potential ingestion of dental materials by patients.

    Product
    Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0475-2023·2023-04-05

    Calcitonin Salmon Nasal Spray Recalled for Out-of-Specification Impurities and Low Potency

    Endo Pharmaceuticals is recalling Calcitonin Salmon Nasal Spray due to out-of-specification impurities and subpotent drug content. Affected lots distributed nationwide have expiration dates ranging from March 2023 to March 2025.

    Product
    CALCITONIN SALMON — CALCITONIN SALMON (CALCITONIN SALMON)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1300-2023·2023-04-05

    PCRopsis Reagent RVD-RT in vitro diagnostic kit recall for misleading labels

    Entopsis, Inc. is recalling PCRopsis Reagent RVD-RT diagnostic kits due to misleading label statements that could affect proper use and test interpretation.

    Product
    PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucleic acid extraction from a variety of biological samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0687-2023·2023-04-05

    Almost Famous Popcorn Poppy Chow recalled for undeclared peanut allergen

    Rieckhoff Family Businesses is recalling Almost Famous Popcorn Poppy Chow because peanuts are listed in ingredients but omitted from the allergen statement. Consumers with peanut allergies may be at serious risk.

    Product
    Almost Famous Popcorn Poppy Chow, 9.9 oz bag (UPC 8 5001151513)
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-0668-2023·2023-04-05

    Seasoned Vegetable Recalled for Undeclared Wheat, Fish, and Sesame

    Lemonland Food Corp recalled Seasoned Vegetable (Deodeok) distributed in Washington due to undeclared allergens: wheat, fish (anchovy), and sesame seeds. Consumers with allergies to these ingredients should not consume the product.

    Product
    Seasoned Vegetable (Deodeok) distributed in un-labeled plastic containers 8oz and 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0487-2023·2023-04-05

    Apollo Care Fentanyl and Ropivacaine Epidural Injection Recalled for Contamination

    Apollo Care is recalling 215 bags of Fentanyl and Ropivacaine epidural injection (Lot AC-016581) due to suspected microbial growth on external packaging. The recall affects product distributed in Missouri.

    Product
    Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0669-2023·2023-04-05

    Perilla Leaves in Soybean Paste recalled for undeclared allergens

    Lemonland Food Corp recalls Perilla Leaves in Soybean Paste for undeclared soybean, wheat, fish, and shrimp allergens. Consumers with these allergies should avoid the product.

    Product
    Perilla Leaves in Soybean Paste distributed in un-labeled plastic containers 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1290-2023·2023-04-05

    GaGa Pro Class IV Laser Projectors Recalled for FDA Compliance Failure

    GaGa Pro Lighting Equipment Co. manufactures Class IV Laser Light Show projectors that are being recalled due to non-compliance with FDA's Performance Standard for laser products. Eleven units distributed nationwide are affected.

    Product
    GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1318-2023·2023-04-05

    Covidien Shiley Lo-Pro Tracheal Tube Cuffed Recalled for Potential Inflation System Leaks

    Covidien is recalling Shiley Lo-Pro Oral/Nasal Tracheal Tubes due to potential leaks in the inflation system. The affected devices, used during anesthesia and procedures, may not maintain proper airway sealing.

    Product
    COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal intubation of the trachea for anesthesia or other short-term procedures.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Drugs)·D-0534-2023·2023-04-05

    Prescription Drug Dabigatran Etexilate Recalled for Excess Nitrosamine Impurity

    Ascend Laboratories is recalling 12,804 bottles of Dabigatran Etexilate 150mg capsules nationwide due to detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake limit caused by manufacturing process deviations.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1293-2023·2023-04-05

    Surgical Robot Instrument Carriage Loose Due to Manufacturing Defect

    Intuitive Surgical is recalling da Vinci Xi and da Vinci X surgical systems because the instrument carriage can become loose due to a manufacturing defect in the linear rail component.

    Product
    da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
    Category
    Medical Device
    Distribution
    1 state