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.

7926–7950 of 27089

  • HighFDA (Food)·F-0338-2025·2025-01-08

    Mixed Fruit Products Recalled for Listeria Contamination Risk

    Gracie's Kitchens Inc. is recalling multiple brands of mixed fruit products due to potential Listeria monocytogenes contamination. Affected products were sold in Connecticut and New York with sell-by dates of November 11-21, 2024.

    Product
    a.) King Kullen brand Mixed Fruit; UPC: 85316-10376; 12 oz plastic container b.) King Kullen brand Mixed Fruit; UPC: 85316-10385; 16 oz plastic container c.) Wild By Nature brand Mixed Fruit; UPC: 85316-10376; 12 oz plastic container d.) Wild By Nature brand Mixed Fruit; UPC: 853
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0341-2025·2025-01-08

    Tropical Fruit Cup Products Recalled for Possible Listeria Contamination

    King Kullen and Gracie's Kitchen brand tropical fruit cups may contain Listeria monocytogenes. Affected products were distributed in Connecticut and New York with sell-by dates from 11/11 to 11/21/24.

    Product
    a.) King Kullen brand Tropical Fruit Cup; UPC: 85316-10384; 16 oz plastic container b.) King Kullen brand Tropical Fruit Cup; UPC: 85316-10403; 12 oz plastic container c.) Gracie's Kitchen brand Tropical Fruit Cup; UPC: 85316-10384; 16 oz plastic container d.) Gracie's Kitchen br
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0774-2025·2025-01-08

    SynchroMed II and III Implantable Pumps Recalled for Software Issues

    Medtronic has recalled 3,981 SynchroMed implantable pumps worldwide due to software issues in application version 2.x used to program the devices.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0324-2025·2025-01-08

    Multiple pineapple products recalled for potential Listeria contamination

    Gracie's Kitchens Inc. is recalling pineapple products sold under King Kullen, Wild By Nature, and Gracie's Kitchen brands in Connecticut and New York due to potential Listeria monocytogenes contamination.

    Product
    a.) King Kullen brand Pineapple Slices; UPC 85316-10007; 20 oz foam tray b) Wild By Nature brand Pineapple Slices; UPC: 85316-10007; 20 oz foam tray c.) King Kullen brand Pineapple Chunks; UPC: 85316-10386; 16 oz plastic container d.) King Kullen brand Pineapple Spears; UPC: 8531
    Category
    Food
    Distribution
    2 states
  • 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 (Devices)·Z-0784-2025·2025-01-08

    Medline Custom Surgical Procedure Kits Recalled for Potential Endotoxin Contamination

    Medline Industries is recalling custom medical procedure kits due to non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. Approximately 1,072 units were distributed in the US, Canada, and UAE.

    Product
    Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B; 2) ENDOSCOPIC SKULL BASE, REF DYNJ58648C; 3) ENT ENDO SINUS WILMINGTON PACK, REF DYNJ66447; 4) ENDOSCOPIC SKULL BASE, REF DYNJ58648D; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648J.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0779-2025·2025-01-08

    Medline Surgical Procedure Kits Recalled for Non-Sterile Components

    Medline is recalling custom surgical procedure kits containing non-sterile surgical components with potential endotoxin contamination. The recall affects 1,402 units distributed in the US, Canada, and UAE.

    Product
    Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177; 3) BURR HOLE SHUNT PACK, REF DYNJ56819D; 4) BURR HOLE SHUNT PACK, REF DYNJ56819F; 5) BURR HOLE SHUNT PACK, REF DYNJ56819G; 6) RO VP SH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-0796-2025·2025-01-08

    Rigid Intracardiac Sucker Units Recalled for Potential Sterility Breach

    Med Michigan Holding recalls SUC-4300S Rigid Intracardiac Suckers due to incomplete or partial pouch seals that may compromise sterility during cardiac surgery.

    Product
    SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0791-2025·2025-01-08

    Medline Deep Brain Stimulation Surgical Kits Recalled for Non-Sterile Contamination

    Medline has recalled 128 Deep Brain Stimulation surgical kits for containing non-sterile Surgical Patties and Strips with potential endotoxin contamination. Affected units were distributed worldwide including the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0322-2025·2025-01-08

    King Kullen and Wild by Nature vegetable platters recalled for Listeria

    Gracie's Kitchens Inc. is recalling King Kullen and Wild by Nature brand vegetable platters (44 oz) distributed in Connecticut and New York due to potential Listeria monocytogenes contamination. Affected products have sell-by dates from November 14-24, 2024.

    Product
    a.) King Kullen brand Vegetable Platter; UPC 85316-10005; 44oz plastic container b.) Wild by Nature brand Vegetable Platter; UPC 85316-10005; 44 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0797-2025·2025-01-08

    3M Unitek Orthodontic Primer Recalled Due to Bond Failures and Skin Irritation

    3M Unitek is recalling Transbond Plus Self-Etching Primer used in orthodontic bonding due to reports of bracket bond failures and skin irritation or blistering.

    Product
    3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bonding process of orthodontic appliances to teeth.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0337-2025·2025-01-08

    Gracie's Kitchens Fiesta Bowl Salads Recalled for Listeria Contamination

    Gracie's Kitchens Inc. is recalling three brands of Fiesta Bowl salads (King Kullen, Wild By Nature, and Gracie's Kitchen) sold in Connecticut and New York due to potential Listeria monocytogenes contamination.

    Product
    a.) King Kullen brand Fiesta Bowl; UPC: 85316-10201; 64 oz plastic container b.) Wild By Nature brand Fiesta Bowl; UPC: 85316-10201; 64 oz plastic c.) Gracie's Kitchen brand Fiesta Bowl; UPC: 85316-10214; 60 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0328-2025·2025-01-08

    Diced Celery Products Recalled Due to Potential Listeria Contamination

    Gracie's Kitchens Inc. is recalling multiple brands of diced celery sold in Connecticut and New York due to potential Listeria monocytogenes contamination.

    Product
    a.) King Kullen brand Diced Celery; UPC: 85316-10083; 12 oz plastic container b.) Wild By Nature brand Diced Celery; UPC: 85316-10083; 12 oz plastic container c.) Gracie's Kitchen brand Diced Celery: UPC: 85316-10020; 10 oz plastic container d.) Gracie's Kitchen brand Diced Celer
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0354-2025·2025-01-08

    Gracie's Kitchen Diced Carrots recalled for potential Listeria monocytogenes contamination

    Gracie's Kitchen brand Diced Carrots may be contaminated with Listeria monocytogenes. The recall affects 3,681 cases distributed in Connecticut and New York with sell-by dates between November 12-22, 2024.

    Product
    a.) Gracie's Kitchen brand Diced Carrots; UPC: 85316-10019; 10 oz plastic container
    Category
    Food
    Distribution
    2 states
  • 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-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 (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-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
  • 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 (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
  • 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-0708-2025·2025-01-01

    Cardiac Monitoring Software Failed to Properly Route ECG Events

    Braemar Manufacturing's Monitoring Service Application (versions 6.5-7.4) failed to properly route and review ECG events from July 2022-July 2024 due to a disabled analysis step. This affected about 130,000 units with 41,282 customers nationwide.

    Product
    Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide