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-1177-2025·2025-02-26

    Irix-A Lumbar Fusion Implants Recalled for Incorrect Expiration Dates

    XTANT Medical Holdings is recalling Irix-A Lumbar Fusion System implants due to incorrect expiration date labeling on sterile spacers. Fourteen units were distributed in Arizona, California, Colorado, Louisiana, Ohio, Texas, West Virginia, and Australia.

    Product
    Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8¿, 19mm, PC, (STERILE))
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1202-2025·2025-02-26

    Dexcom G6 Glucose Monitor May Fail to Deliver Alarms Properly

    Dexcom G6 continuous glucose monitors may fail to deliver high or low blood sugar alarms due to a software error, potentially delaying detection of dangerous glucose levels. Alarms will be delayed and skip in sequence until the device is reset.

    Product
    Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1175-2025·2025-02-26

    3M Prevena Plus Negative Pressure Therapy System Recalled for Leak Alarm Malfunctions

    KCI USA is recalling 3M Prevena Plus wound therapy systems due to complaints about malfunctioning leak alarms. The recall affects 135,268 units distributed worldwide.

    Product
    3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena Plus Peel and Place 35 cm system Kit PRE4000US Prevena Plus 125 Therapy Unit, U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0236-2025·2025-02-26

    Atomoxetine 80 mg Capsules Recalled for N-Nitroso Impurity Contamination

    Glenmark Pharmaceuticals is recalling 87,600 bottles of Atomoxetine 80 mg capsules nationwide due to N-Nitroso Atomoxetine impurity detected above FDA-recommended limits. Consult your healthcare provider if affected.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1173-2025·2025-02-26

    Medline Medical Convenience Kits Recalled for Catheter Sterility Issue

    Medline is recalling medical convenience kits assembled with Coloplast Foley and prostatic catheters that were recalled due to a potential sterility issue detected during testing.

    Product
    Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    1 state
  • 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 (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-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 (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 (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-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-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 (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-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
  • 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
  • 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-0541-2025·2025-02-19

    Riverside Cookies & Creme Granola Bars Recalled for Potential Metal Contamination

    Riverside Natural Foods is recalling Cookies & Creme Granola Bars nationwide due to possible metal contamination. Consumers should not consume the affected products.

    Product
    1. Cookies & Creme Granola Bars 30.6oz (36 bars) 2. Cookies & Creme Granola Bars 5.1oz (6 bars) 3. Cookies & Creme Granola Bars 0.85 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1131-2025·2025-02-19

    Cardinal Health Laryngoscopy Packs Recalled for Potential Endotoxin Contamination

    Cardinal Health Presource Kits containing laryngoscopy packs are being recalled due to potential endotoxin contamination in non-sterile surgical strips and patties.

    Product
    Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0538-2025·2025-02-19

    Chocolate Banana Granola Bars Recalled for Potential Metal Contamination

    Riverside Natural Foods is recalling Chocolate Banana Granola Bars sold nationwide due to potential metal contamination. Consumers should not eat affected products and should consult a healthcare provider if consumed.

    Product
    1. Chocolate Banana Granola Bars; 5.1oz (6 bars) 2. Chocolate Banana Granola Bars; 0.85oz
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2025·2025-02-19

    Medical laser device recalled for inadequate safety operating instructions

    Ithera Medical is recalling the MSOT Acuity Echo medical laser device worldwide due to inadequate instructions for safe operation. Previous user manuals contained an incorrect Nominal Ocular Hazard Distance value.

    Product
    The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0542-2025·2025-02-19

    Halloween Chocolate Chip Granola Mini Bars recalled for possible metal contamination

    Riverside Natural Foods is recalling Halloween Chocolate Chip Granola Mini Bars distributed nationwide due to possible metal pieces. Consumers should not eat these products.

    Product
    1. Halloween Chocolate Chip Granola Mini Bars 12.6oz (30 bars) 2. Halloween Chocolate Chip Granola Mini Bars 0.42oz
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1124-2025·2025-02-19

    Medication Cabinet Recall: BD Pyxis MedStation Auxiliary 4000 Drawer and Door Failures

    The BD Pyxis MedStation Auxiliary 4000 medication cabinet may experience drawer and door failures, potentially delaying medication access in healthcare facilities.

    Product
    BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
    Category
    Medical Device
    Distribution
    Distributed nationwide