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.

17751–17775 of 27263

  • HighFDA (Devices)·Z-1310-2023·2023-04-05

    Iradimed MRidium MRI Infusion Pump Syringe Adapter Sets Recalled for Occlusion Risk

    Iradimed is recalling MRidium MRI 1000 Series Infusion Set Syringe Adapter Sets due to a defective part that can limit venting function and cause occlusion, potentially interrupting medication delivery.

    Product
    Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0682-2023·2023-04-05

    Hot Pepper in Soy Sauce Recalled for Undeclared Soy and Wheat

    Lemonland Food Corp recalled Hot Pepper in Soy Sauce distributed in 12-ounce containers due to undeclared soybean and wheat allergens. Consumers with soy or wheat allergies should not consume this product.

    Product
    Hot Pepper 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
    0 states
  • HighFDA (Food)·F-0685-2023·2023-04-05

    Stainless Steel Water Bottles Recalled for Lead Leaching from Welded Screw Cap

    BINDLE BOTTLE is recalling Stainless Steel Water Bottles because the cup's screw cap is attached by a weld that leaches lead into drinking water.

    Product
    Stainless Steel Water Bottle The product comes in four sizes: 32 oz., 24 oz., 20 oz., and 13 oz.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0652-2023·2023-04-05

    Rold Gold Original Tiny Twists Pretzels Recalled for Undeclared Soy

    Frito-Lay is recalling Rold Gold Original Classic Tiny Twists Pretzels because the product contains undeclared soy lecithin, which may affect consumers with soy allergies.

    Product
    Rold Gold Original Classic Tiny Twists Pretzels in 16oz UPC 2840004768 packaged in a flexible bag
    Category
    Food
    Distribution
    5 states
  • 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
    0 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-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 (Devices)·Z-1311-2023·2023-04-05

    Fluoroscopic X-Ray System Recalled for Unintended Table Movement Risk

    Siemens ARTIS pheno X-ray systems may experience unintended table movement that the system fails to detect, risking injury to patients, staff, or operators. The FDA is recalling 141 affected units nationwide.

    Product
    ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.
    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 (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
    0 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 (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
    0 states
  • HighFDA (Drugs)·D-0479-2023·2023-04-05

    Ropinirole 1 mg Tablets Recalled Nationwide for Manufacturing Process Deviations

    Direct Rx is recalling Ropinirole 1 mg tablets nationwide due to manufacturing process deviations. Consult a pharmacist before stopping this medication.

    Product
    Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0658-2023·2023-04-05

    Stir-Fried Fish Cake Recalled Due to Undeclared Allergens

    Lemonland Food Corp recalled stir-fried fish cake due to undeclared soybean, wheat, fish, and sesame allergens. The affected products were distributed in Washington from February 16 to 23, 2023.

    Product
    Stir-Fried Fish Cake 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
    0 states
  • HighFDA (Food)·F-0678-2023·2023-04-05

    Seasoned Lotus Root Recalled for Undeclared Soybean and Wheat

    Lemonland Food Corp recalled Seasoned Lotus Root for containing undeclared soybean and wheat allergens. Consumers with allergies to these allergens should not consume the product.

    Product
    Seasoned Lotus Root 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
    0 states
  • 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
    0 states
  • 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
    0 states
  • HighFDA (Devices)·Z-1294-2023·2023-04-05

    CoCr Femoral Head hip implant compatibility removed due to motion limitations

    Zimmer is updating the compatibility matrix for the CoCr Femoral Head XS hip implant to remove pairing with Epsilon Durasul Constrained Acetabular Liners due to insufficient range of motion in flexion/extension.

    Product
    CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1302-2023·2023-04-05

    Chest Drain Valve Recalled for Insufficient Safety Instructions

    The Atrium Pneumostat Chest Drain Valve has been recalled because its instructions lack sufficient precautions against improper drainage and use outside healthcare settings.

    Product
    Atrium Pneumostat Chest Drain Valve, Part Number 16100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1314-2023·2023-04-05

    Irvine Scientific embryo culture oil recalled due to detected toxicity

    Fujifilm Irvine Scientific is recalling its Oil for Embryo Culture product due to detection of oil toxicity in several manufacturing lots. A total of 15,131 bottles are affected.

    Product
    Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Food)·F-0674-2023·2023-04-05

    Seasoned Radish Sliced Recalled for Undeclared Fish, Shrimp, and Sesame

    Lemonland Food Corp is recalling Seasoned Radish Sliced products distributed in Washington due to undeclared Fish, Crustacean, and Sesame allergens. Consumers with these allergies should not consume this product.

    Product
    Seasoned Radish Sliced distributed in un-labeled plastic containers 6oz., 8 oz., and 12 oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0655-2023·2023-04-05

    Seasoned Pollack Roe Recalled for Undeclared Fish Allergen

    Lemonland Food Corp is recalling Seasoned Pollack Roe due to undeclared fish allergen. The product was distributed in Washington from February 16-23, 2023.

    Product
    Seasoned Pollack Roe distributed in un-labeled plastic containers 6oz and 8oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0672-2023·2023-04-05

    Seasoned Garlic Stem Recalled Due to Undeclared Fish and Sesame Allergens

    Lemonland Food Corp recalled Seasoned Garlic Stem products due to undeclared fish (anchovy) and sesame allergens. Affected products were distributed in Washington from February 16-23, 2023.

    Product
    Seasoned Garlic Stem distributed in un-labeled plastic containers 8oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0665-2023·2023-04-05

    Stir-Fried Kimchi Recalled for Undeclared Allergens: Fish, Shrimp, Wheat, Sesame

    Lemonland Food Corp recalls 12 oz. containers of Stir-Fried Kimchi distributed in Washington due to undeclared allergens: fish (anchovy), shrimp, wheat, and sesame. Consumers with allergies to these ingredients should not consume this product.

    Product
    Stir-Fried Kimchi distributed in un-labeled plastic containers 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0673-2023·2023-04-05

    Wild Leek Recalled for Undeclared Soy, Wheat, and Fish Allergens

    Lemonland Food Corp is recalling Wild Leek sold in Washington due to undeclared allergens: soybean, wheat, and fish (anchovy). Consumers with allergies to these ingredients should avoid this product.

    Product
    Wild Leek 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
    0 states