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.

17726–17750 of 27263

  • 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 (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-1304-2023·2023-04-05

    ACL Elite Analyzer HemosIL Liquid Anti-Xa test definition removal

    Instrumentation Laboratory is removing the HemosIL Liquid Anti-Xa test definition from ACL Elite/Elite Pro Analyzers. This affects 358 units in the US and 558 units internationally.

    Product
    ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
    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 (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 (Devices)·Z-1303-2023·2023-04-05

    Express Mini 500 Chest Drain Recalled for Inadequate Instructions

    The Express Mini 500 Dry Seal Chest Drain has been recalled because its instructions do not adequately warn against draining it for continued use or using it outside healthcare settings. Approximately 8,184 cases were distributed worldwide.

    Product
    Express Mini 500 Dry Seal Chest Drain, Part Number 16400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0689-2023·2023-04-05

    Mary's Gone Crackers recalled for potential foreign material contamination

    Mary's Gone Crackers Super Seed Seaweed & Black Sesame Crackers may contain foreign material. Approximately 2,376 cases were distributed throughout the USA.

    Product
    Mary s Gone Crackers Super Seed Seaweed & Black Sesame Crackers Product Item number: 10033380101 UPC: 8 53665 00510 7
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1291-2023·2023-04-05

    Alcon Custom Pak Surgical Procedure Packs Recalled for Incomplete Seals

    Alcon Research is recalling 1,035 Custom Pak Surgical Procedure Packs with incomplete seals that affect sterility. These packs were distributed to surgical facilities in 14 US states.

    Product
    Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 1913
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1306-2023·2023-04-05

    FDA recalls ACL ELITE refurbished analyzer to remove Anti-Xa test

    Instrumentation Laboratory recalled ACL ELITE refurbished coagulation analyzers to remove the HemosIL Liquid Anti-Xa test definition.

    Product
    ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0688-2023·2023-04-05

    Danncy Vainilla Pure Mexican Vanilla Extract Contains Prohibited Coumarin

    Danncy Vainilla Pure Mexican Vanilla Extract is being recalled because the product contains coumarin, a prohibited substance. Consumers should stop using the product.

    Product
    Danncy Vainilla Pure Mexican Vanilla Extract Clear Gluten Free Produced by Juan Miguel Anzaldua Gutierrez NET 33.8 FL OZ (1.0L) UPC 7503000781137 packaged in clear plastic bottles and Danncy Vainilla Pure Mexican Vanilla Extract Gluten Free Produced by Juan Miguel Anzaldua Gutier
    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-0659-2023·2023-04-05

    Spicy Cucumber Salad recalled for undeclared sesame, fish, and wheat allergens

    Lemonland Food Corp recalls Spicy Cucumber Salad due to undeclared sesame seeds, fish (anchovy), and wheat allergens. The product was distributed in multiple container sizes in Washington.

    Product
    Spicy Cucumber Salad 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 (Devices)·Z-1309-2023·2023-04-05

    Leksell Stereotactic System Recall: Incorrect Instructions Distributed with Devices

    Elekta Instrument AB is recalling 70 Leksell Stereotactic System neurosurgical devices due to incorrect Instructions for Use being distributed with the devices. Incorrect documentation for neurosurgical equipment could impact proper device use.

    Product
    Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part #A2800-15, Backlund Catheter Insertion Needle Kit I; (3) Part #A2600-01, Backlund Haematoma Evac
    Category
    Medical Device
    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-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-0663-2023·2023-04-05

    Seasoned Hot Pepper Leaves recalled for undeclared fish and sesame allergens

    Lemonland Food Corp recalls Seasoned Hot Pepper Leaves from Washington due to undeclared Fish (Anchovy) and Sesame Seeds allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    Seasoned Hot Pepper Leaves 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-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 (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 (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 (Devices)·Z-1286-2023·2023-04-05

    CRP Immunoturbidimetric Reagent Recalled for Positive Bias in Patient Samples

    Randox Laboratories is recalling CRP Immunoturbidimetric reagent Batch 588434 because the antibody component shows a positive bias on patient samples, producing elevated test results compared to previous batches. Quality control samples remain within acceptable range.

    Product
    CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1316-2023·2023-04-05

    Baxter Automated Peritoneal Dialysis System Electrical Safety Testing Failure

    Baxter Healthcare Corporation is recalling 16 Automated Peritoneal Dialysis Systems due to incomplete electrical safety testing. Affected devices require additional testing.

    Product
    Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
    Category
    Medical Device
    Distribution
    10 states
  • 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
    0 states
  • HighFDA (Food)·F-0675-2023·2023-04-05

    Seasoned Dried Pollack Recalled for Undeclared Allergens

    Lemonland Food Corp is recalling Seasoned Dried Pollack distributed in Washington for undeclared Fish, Wheat, and Soybean allergens. Consumers with these allergies should not consume this product.

    Product
    Seasoned Dried Pollack 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 (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 (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