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.

7126–7150 of 26961

  • HighFDA (Devices)·Z-1192-2025·2025-02-26

    RayStation radiation therapy planning software density uncertainty computational defect

    RayStation treatment planning software versions 4.5 through 2024B may incorrectly handle density uncertainty in radiation dose calculations for proton and light ion therapy. An inconsistency in three key functions could affect treatment planning accuracy.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6 Software Version: RayStation 6 Service Pack 1, 2 and 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0232-2025·2025-02-26

    Atomoxetine Capsules Recalled for N-Nitroso Impurity Above FDA Limits

    Glenmark Pharmaceuticals is recalling Atomoxetine capsules due to N-Nitroso impurity levels exceeding FDA recommended limits. The recall affects 56,208 bottles nationwide with specific lot numbers.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1174-2025·2025-02-26

    DeRoyal AMG Suction Connector Tubing connection may fail to seal

    DeRoyal Industries is recalling AMG Suction Connector Tubing because the connection between the tubing and suction device may not seal properly, potentially affecting patient care.

    Product
    DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Drugs)·D-0243-2025·2025-02-26

    Atomoxetine Capsules Recalled Due to N-Nitroso Impurity Contamination

    Glenmark Pharmaceuticals is recalling approximately 58,416 bottles of Atomoxetine 80 mg capsules nationwide due to the presence of N-Nitroso Atomoxetine impurity above FDA-recommended limits. This is a Class II recall.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1187-2025·2025-02-26

    RayStation radiation therapy planning software density uncertainty calculation inconsistency

    RayStation radiation therapy planning software contains an inconsistency in density uncertainty calculations affecting robust optimization and dose computation functions for proton and light ion treatment plans.

    Product
    Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10 Software Version: RayStation 9B, 9B Service Pack 1, 10A, 10A Service Pack 1 and 2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0238-2025·2025-02-26

    Atomoxetine Capsules Recalled for Chemical Impurity Above FDA Limits

    Glenmark Pharmaceuticals is recalling 120,000 bottles of Atomoxetine 10 mg capsules nationwide due to N-nitroso Atomoxetine impurity exceeding FDA recommended limits. Multiple lot numbers are affected with expiration dates through July 2026.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1116-2025·2025-02-19

    Wheelchair Speed Control Remote Recalled Due to Loss-of-Control Risk

    The Smart Drive MX2+ SpeedControl Dial remote is being recalled due to a faulty circuit board that could cause loss of control of the wheelchair power assist, potentially resulting in injury.

    Product
    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Food)·F-0554-2025·2025-02-19

    Menma Ajitsuke Bamboo Shoots Recalled for Missing Refrigeration Label

    AKT Trading Inc. is recalling Menma Ajitsuke prepared bamboo shoots because the packaging is missing a "Keep Refrigerated" statement. The product requires refrigeration and improper storage could allow bacterial growth.

    Product
    Menma Ajitsuke prepared bamboo shoots; Product of Japan; Manufactured by: Choshiya Honten CO., LTD. Hamamatsu 431-1103 Japan UPC 4 923673 527332. Product is packaged in 8.8 OZ Plastic Pouches. 60 units per case.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0548-2025·2025-02-19

    Shirakiku Curvee Puffs Corn Puff Snack Recalled for Undeclared Milk Allergen

    Wismettac Asian Foods is recalling Shirakiku brand Curvee Puffs Corn Puff Snack because the product contains undeclared milk allergen. The affected product was distributed nationwide to approximately 471 consignees.

    Product
    Front Panel: Shirakiku brand, CURVEE PUFFS CORN PUFF SNACK, Curry Flavor, NET WT 2.46 oz (70 g); Rear panel:Best Before YYYY.MM.DD; Nutritional Facts: 2.5 servings per container; Distributed by Wismettac Asian Foods, Inc.; 13409 Orden Drive, Santa Fe Spring, CA 90670; Product of
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0553-2025·2025-02-19

    Pearl Milling Pancake & Waffle Mix Recalled for Undeclared Milk Allergen

    Frito-Lay is recalling Pearl Milling Company Original Pancake & Waffle Mix due to undeclared milk allergen. The product may cause allergic reactions in consumers with milk allergies.

    Product
    Pearl Milling Company Original Pancake & Waffle Mix 32 OZ (2LB) 907g 30000 65040 BBD SEP 13 25 P
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1117-2025·2025-02-19

    Wheelchair Power Assist Speed Control Dial Recalled for Loss of Control Risk

    Max Mobility Smart Drive MX2+ SpeedControl Dial wheelchairs are being recalled due to faulty circuit boards that may cause loss of device control, potentially resulting in injury to users.

    Product
    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-1074-2025·2025-02-19

    Sevoflurane Vaporizer Quik-Fil Recalled Due to Chemical Degradation Risk

    A sevoflurane vaporizer component may degrade to hydrogen fluoride, causing respiratory damage and chemical burns to patients and workers. FDA classified this Class I recall affecting six units in Kentucky and Connecticut.

    Product
    Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0550-2025·2025-02-19

    Shirakiku Curvee Puffs Corn Snack Recalled for Undeclared Milk Allergen

    Wismettac Asian Foods is recalling Shirakiku brand Curvee Puffs Corn Puff Snacks due to undeclared milk. The product poses a serious risk to consumers with milk allergies. All lots distributed nationwide are affected.

    Product
    Front Panel: Shirakiku brand, CURVEE PUFFS CORN PUFF SNACK, Corn Potage Flavor, NET WT 2.46 oz (70 g); Rear panel:Best Before YYYY.MM.DD; Nutritional Facts: 2.5 servings per container; Distributed by Wismettac Asian Foods, Inc.; 13409 Orden Drive, Santa Fe Spring, CA 90670; Produ
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0551-2025·2025-02-19

    Frozen Mini Pastries Recalled for Potential Salmonella Contamination

    Sweet Cream Mini Patisseries frozen pastry trays are being recalled due to potential Salmonella contamination. Affected products were distributed in New Jersey and Florida with best-before dates through November 2025.

    Product
    Sweet Cream Mini Patisseries, 30 piece variety tray of mini pastries, Net Wt 1 kg, 4 trays per master carton, total Net wt 8.8 lbs, Keep Frozen, All best before dates from 2025/06/17 up to and including 2025/11/15.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1071-2025·2025-02-19

    Olympus Guide Sheath Kits recalled for potential radiopaque tip detachment

    Olympus Single Use Guide Sheath Kits (models K-201 through K-204) are recalled because the radiopaque tip of the guide sheath may detach and fall into the patient during respiratory procedures.

    Product
    Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-201 2. Single Use Guide Sheath Kit K-202 2.0MM Channel Set:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0552-2025·2025-02-19

    Fresh Direct Dark Chocolate Pretzels Recalled for Undeclared Milk Allergen

    Fresh Direct Dark Chocolate Pretzels 7oz bags are recalled due to undeclared milk allergen. The recall affects 99 cases distributed to New York (Lot #24353).

    Product
    Fresh Direct Dark Chocolate Pretzels 7oz, Bag. 12 bags per case.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0549-2025·2025-02-19

    Shirakiku Curvee Puffs Corn Puff Snack Recalled for Undeclared Milk Allergen

    Wismettac Asian Foods, Inc. is recalling Shirakiku brand Curvee Puffs Corn Puff Snack due to undeclared milk on the label. Consumers with dairy allergies should not consume this product.

    Product
    Front Panel: Shirakiku brand, CURVEE PUFFS CORN PUFF SNACK, Sea Salt & Umami Flavor, NET WT 2.46 oz (70 g); Rear panel:Best Before YYYY.MM.DD; Nutritional Facts: 2.5 servings per container; Distributed by Wismettac Asian Foods, Inc.; 13409 Orden Drive, Santa Fe Spring, CA 90670;
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2025·2025-02-19

    Cardinal Health Presource surgical kits recalled for endotoxin contamination risk

    Cardinal Health is recalling Presource Kits for potential endotoxin contamination in non-sterile surgical strips and patties. These surgical components could pose infection risks if used in procedures.

    Product
    Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0555-2025·2025-02-19

    Orange Jelly Sticks Recalled for Undeclared Food Additives

    The Candy Basket Inc recalls Orange Jelly Sticks MILK for undeclared Yellow #6 and Sodium Benzoate affecting 516 4-lb. boxes distributed in California, Oregon, and Washington.

    Product
    Orange Jelly Sticks MILK, item number CB741-M, is packed and sold in bulk 4lbs. boxes. Product does not have a UPC and is not repackaged for retail. Product was sold out of bulk chocolate cases from candy stores to consumers without any labeling. Label on bulk 4lbs. box declare
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0563-2025·2025-02-19

    Cheese powder ingredient blend recalled for plastic thread contamination

    Bridgewell Agribusiness recalls 5912MOD-CAU Pre-Blend (lot 220349) due to plastic thread contamination. The dry ingredient was distributed only in New York.

    Product
    5912MOD-CAU Pre-Blend, item #991819, is a dry blend. Ingredients consist of Tapioca Starch, Long Grain Rice Flour, Cheese Powder [Cheddar Cheese (Cultured Pasteurized Milk, Salt, Enzymes), Disodium Phosphate, Salt], Rice Starch, Sugar, Salt, Encapsulated Baking Soda (Sodium Bicar
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0543-2025·2025-02-19

    Riverside Natural Foods Recalls Birthday Cake Granola Bars for Possible Metal Contamination

    Riverside Natural Foods is recalling Chocolate Drizzled Birthday Cake Granola Bars in multiple sizes nationwide because they may contain metal pieces. Consumers should discard the product or return it to the retailer.

    Product
    1. Chocolate Drizzled Birthday Cake Granola Bars 25.5oz (30 bars) 2. Chocolate Drizzled Birthday Cake Granola Bars 4.2oz (5 bars) 3. Chocolate Drizzled Birthday Cake Granola Bars 17oz (20 bars) 4. Chocolate Drizzled Birthday Cake Granola Bars 8.5oz (10 bars) 5. Chocolate Drizzl
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1127-2025·2025-02-19

    Cardinal Health Presource Kits recalled for endotoxin contamination risk

    Cardinal Health is recalling Presource Kits containing surgical strips and patties due to potential endotoxin contamination. Approximately 973,785 units were distributed in the US, Canada, and Saudi Arabia.

    Product
    Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMDX;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1164-2025·2025-02-19

    Diagnostic HPV Verification Panel Recalled Due to Quality Control Failures

    Microbiologics Inc is recalling HPV verification test panels (REF 8235) due to quality control failures that allowed defective units to be released. The panels may produce invalid test results or fail to detect HPV.

    Product
    Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
    Category
    Medical Device
    Distribution
    Distributed nationwide