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.

7801–7825 of 26961

  • HighFDA (Devices)·Z-0793-2025·2025-01-08

    Medline custom surgical procedure kits recalled for non-sterile components

    Medline is recalling 182 custom surgical procedure kits containing non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. The kits were distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM-LF, REF DYNJ35184F; 3) ANTERIOR CERVICAL-CORPECTOMY, REF DYNJ904827.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0780-2025·2025-01-08

    Medline custom surgical procedure kits recalled for non-sterile components and endotoxin contamination

    Medline custom procedure kits containing non-sterile Codman Surgical Patties & Strips are being recalled due to potential endotoxin contamination. The recall affects 74 units distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476; 2) DIEP FLAP, REF DYNJ910120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0362-2025·2025-01-08

    Beef & Lamb Gyro Meal Kit Recalled for Salmonella Risk

    Reser's Fine Foods is recalling Beef & Lamb Gyro Sandwich Express Meal Kits due to potential Salmonella contamination in the tzatziki sauce. The recall affects 5,271 cases distributed across 19 states.

    Product
    Beef & Lamb Gyro Sandwich Express Meal Kit. Net wt. 31.8oz. UPC 0 13454 38313 1. Each kit contains 6 Pitas, Gyro Meat, Tzatziki Sauce 3oz. cups, Fire Feta Sauce, Feta Cheese Crumbles. Packaged in clear plastic clamshell. Distributed by Fresh Creative Foods, Vista CA.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-0342-2025·2025-01-08

    Halo Bowl Recalled Due to Potential Listeria Monocytogenes Contamination

    Three brands of Halo Bowl (King Kullen, Wild by Nature, Gracie's Kitchen) are recalled for potential Listeria monocytogenes contamination. Affected products sold in CT and NY with Sell By dates 11/11–11/21/24.

    Product
    a.) King Kullen brand Halo Bowl; UPC: 85316-10390; 28 oz plastic container b.) Wild by Nature brand Halo Bowl; UPC: 85316-10390; 28 oz plastic container c.) Gracie's Kitchen brand Halo Bowl; UPC: 85316-10312; 28 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0794-2025·2025-01-08

    Medline surgical procedure kits recalled for non-sterile components and endotoxin contamination

    Medline is recalling 474,300 custom surgical procedure kits because they contain non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. These components could pose infection risks during surgical procedures.

    Product
    Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2) CRANIOFACIAL CDS, REF CDS780102K; 3) CRANIOFACIAL CDS, REF CDS780102L; 4) CRANIOFACIAL CDS, REF CDS780102M; 5) CRANIOTOMY CDS-LF, REF CDS780105K; 6) CRANIOTOMY CDS-LF, REF CDS780105L; 7) CRANIO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0351-2025·2025-01-08

    Gracie's Kitchen Broccoli & Cauliflower Florets Recalled for Listeria

    Gracie's Kitchen brand Broccoli & Cauliflower Florets (12 oz foam trays) are being recalled due to potential Listeria monocytogenes contamination. The recalled products were distributed in Connecticut and New York.

    Product
    a.) Gracie's Kitchen brand Broccoli & Cauliflower Florets; UPC: 85316-1009; 12 oz foam tray
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0344-2025·2025-01-08

    Watermelon Halo Products Recalled for Potential Listeria Contamination

    King Kullen and Gracie's Kitchen brand Watermelon Halo products are being recalled due to potential Listeria monocytogenes contamination. The products were distributed in Connecticut and New York with sell-by dates from November 11 through November 21, 2024.

    Product
    a.) King Kullen brand Watermelon Halo; UPC: 85316-10392; 26 oz plastic container b.) Gracie's Kitchen brand Watermelon Halo; UPC: 85316-10392; 26 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0320-2025·2025-01-08

    Chocolate Raspberry Bakery Products Recalled for Undeclared Allergens and Color Additives

    Lithuanian Bakery, Inc. is recalling Chocolate Raspberry baked goods in three sizes due to undeclared milk, soy, peanut, wheat, sulfites, and color dyes. Consumers with allergies should not consume these products.

    Product
    Chocolate Raspberry: Three sizes, 1. Small, Net Wt 1.25 lbs. (sub ingredients contain, yellow #5 and #6, and red #40 not declared on final product label) 2. Medium, Net Wt 2.75 lbs. (sub ingredients contain milk, yellow #5 and #6, and red #40 not declared on final product labe
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0775-2025·2025-01-08

    Baxter SIGMA Spectrum Infusion Pump Recalled for Incomplete Post-Repair Testing

    Baxter is recalling SIGMA Spectrum Infusion Pump (Version 6) units that were released after repair without complete flow testing. The incomplete testing poses a risk of improper device operation.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0782-2025·2025-01-08

    Medical Device Kits Recalled for Non-Sterile Surgical Components

    Medline Industries is recalling See DocMan custom convenience kits that contain non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. Approximately 48,655 units were distributed worldwide.

    Product
    See DocMan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0355-2025·2025-01-08

    Gracie's Kitchen Mango & Blueberry Cup Recalled for Possible Listeria Contamination

    Gracie's Kitchen brand Mango & Blueberry Cup may be contaminated with Listeria monocytogenes. The recall affects 3,681 cases distributed in Connecticut and New York.

    Product
    a.) Gracie's Kitchen brand Mango & Blueberry Cup; UPC: 85316-10347; 12 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0783-2025·2025-01-08

    Medline Surgical Procedure Kits Recalled for Non-Sterile Components

    Medline is recalling 943 custom surgical kits containing non-sterile Codman Surgical Patties and Strips that may be contaminated with endotoxin.

    Product
    Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-RF, REF DYNJ21927R; 3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A; 4) DR GOLDSTEIN ACCESSORY PACK, REF DYNJ51818F; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0331-2025·2025-01-08

    Peppers & Onions Products Recalled for Listeria Contamination Risk

    Multiple brands of peppers & onions products are being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed in Connecticut and New York.

    Product
    a.) King Kullen brand Peppers & Onions; UPC: 85316-10087; 12 oz plastic container b.) Wild by Nature brand Peppers & Onions; UPC: 85316-10087; 12 oz plastic container c.) Gracie's Kitchen brand Peppers & Onions; UPC: 85316-10001; 12 oz plastic container d.) Gracie's Kitchen brand
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0770-2025·2025-01-08

    Auryon Laser Atherectomy System Recalled for Activation Failure

    Angiodynamics is recalling 138 units of the Auryon atherectomy laser system due to potential failure to advance to activation mode during use. This malfunction could cause procedural delays or interruptions.

    Product
    AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0168-2025·2025-01-08

    AvKARE Nitrofurantoin 100 mg Capsules Recalled for Dissolution Failures

    AvKARE is recalling Nitrofurantoin 100 mg capsules (NDC 50268-625-15, lot 47101, exp. 02/2026) nationwide because they failed dissolution specifications. Affected users should consult their healthcare provider.

    Product
    Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0171-2025·2025-01-08

    Dapsone Gel Recalled Nationwide for Crystallization

    Viona Pharmaceuticals is recalling Dapsone Gel 7.5% nationwide due to crystallization detected in multiple lots. Patients should contact their pharmacy or healthcare provider for guidance.

    Product
    DAPSONE — DAPSONE (DAPSONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0375-2025·2025-01-08

    Wegmans Jalapeno Baked Cheese Puffs Recalled for Undeclared MSG

    Herr Foods Inc is recalling Wegmans Jalapeno Baked Cheese Puffs due to undeclared monosodium glutamate and flavor compounds. Affected units have expiration dates from December 2024 through May 2025.

    Product
    Wegmans Jalapeno Baked Cheese Puffs, Jalapeno flavored, 10oz, (283 g), SKU #6877
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0175-2025·2025-01-08

    Carboxymethylcellulose sodium eye drops recalled for label mix-up

    AvKARE is recalling Carboxymethylcellulose Sodium Ophthalmic Solution eye drops due to a label mix-up. The recall affects 16,677 cartons distributed nationwide.

    Product
    CARBOXYMETHYLCELLULOSE SODIUM — CARBOXYMETHYLCELLULOSE SODIUM (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0176-2025·2025-01-08

    Eye drops recalled nationwide due to labeling mix-up

    AvKARE is recalling Polyvinyl Alcohol Ophthalmic Solution eye drops due to a labeling mix-up. The recall affects Lot #0160 and was distributed nationwide.

    Product
    POLYVINYL ALCOHOL — POLYVINYL ALCOHOL (POLYVINYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0314-2025·2025-01-01

    Kirkland Signature Organic Eggs Recalled Due to Salmonella Risk

    Kirkland Signature Organic Eggs sold at Costco have been recalled due to potential Salmonella contamination. The recalled eggs were distributed to retail facilities in Alabama, Georgia, North Carolina, South Carolina, and Tennessee.

    Product
    Kirkland Signature ORGANIC EGGS PASTURE-RAISED 24 EGGS, GRADE A LARGE, NET WEIGHT 48OZ (3 LB) 1.36 kg, UPC 0 96619 10680 6, DISTRIBUTED BY: COSTCO WHOLESALE CORPORATION 730 LAKE DRIVE, ISSAQUAH, WA 98027
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0682-2025·2025-01-01

    Blood Glucose Ketone Meter Firmware Bug Causes Inaccurate Test Results

    Software bug in StatStrip Glucose Ketone Hospital Meter System can cause incorrect blood glucose and ketone test results to be transmitted to healthcare data systems. 347 units affected.

    Product
    StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0681-2025·2025-01-01

    Glucose Hospital Meter Software Bug Transmits Inaccurate Results

    StatStrip Glucose Hospital Meter software bug may transmit erroneous glucose values to healthcare systems, potentially leading to incorrect patient treatment. 2,365 units affected nationwide and internationally.

    Product
    StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0683-2025·2025-01-01

    Blood glucose ketone meter software bug causes erroneous result transmission

    Nova Biomedical's StatStrip glucose ketone hospital meter (Model 63910) has a software bug that may transmit erroneous results to healthcare systems. The issue affects 1,615 units distributed across the US and internationally.

    Product
    StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0313-2025·2025-01-01

    Raw Cucumbers Recalled for Potential Salmonella Contamination Risk

    SunFed Produce, Inc. is recalling raw cucumbers distributed nationally and internationally due to potential Salmonella contamination. The recall affects 71,070 cases.

    Product
    Raw cucumbers packaged in cardboard boxes or plastic boxes (RPC) with "SunFed", "Vegetables", or "Agrotato" labeling. 1 1/9 BU CAS Super Slicer Cucumber/10814780010749 1 1/9 BU CAS Select Slicer Cucumber/10814780010756 1 1/9 BU CAS Large Slicer Cucumber/10814780010763 1 1/9 BU
    Category
    Food
    Distribution
    0 states