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.

6401–6425 of 26654

  • ModerateFDA (Food)·F-0670-2025·2025-04-02

    Beverage concentrate recall due to undeclared Red #3 dye

    Paletas Ice Cream is recalling Flor de Michoacan Blue Hawaiian Beverage Concentrate because the product contains undeclared Red #3 dye. Affected products were distributed in Arizona, New Mexico, Texas, and Utah.

    Product
    Flor de Michoacan Blue Hawaiian Artificially Flavored Beverage Concentrate. 1 Gallon (3.78L) Pasteurized. Keep Frozen. UPC 1 80596-00039 1. Processed for: Paletas Ice Cream, El Paso, Texas 79907
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1432-2025·2025-04-02

    Orthofix Pillar SA Ti Spacer System Mislabeled for Anterior Height

    Orthofix is recalling Pillar SA Ti Spacer System spinal implants because the product label lists an incorrect anterior height of 10mm, while the actual device measures 10.5mm. This labeling discrepancy could affect surgical planning during implantation.

    Product
    Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm W x 28mm D x 10mm H, 7 degrees; and (3) REF 82-4000SP, 40mm W x 32mm D x 10mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1412-2025·2025-04-02

    Baxter Mobile Column TruSystem 7500 Software Defect Prevents Back Adjustment

    Baxter Healthcare is recalling the Mobile column TruSystem 7500 due to a software issue that prevents the upper back section from being adjusted when emergency mode is enabled. Approximately 1,596 units distributed nationwide are affected.

    Product
    Baxter Mobile column TruSystem 7500, Product Code 1717023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0666-2025·2025-04-02

    Our Family Traverse City Cherry Ground Coffee Recalled for Mislabeling

    Our Family Traverse City Cherry Ground Coffee (12 oz) has been recalled due to mislabeling. A portion of production was labeled as decaffeinated when it contains regular caffeine.

    Product
    COFFEE ROASTERS Our Family TRAVERSE CITY CHERRY ARTIFICIALLY FLAVORED DECAF LIGHT ROAST GROUND COFFEE NET WT 12 OZ (340g) UPC 0 70253 11080 1 DISTRIBUTED BY THE SPARTANNASH COMPANY GRAND RAPIDS, MI 49518
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-0660-2025·2025-03-26

    Ready Care Chocolate Shake Plus Recalled for Potential Listeria Contamination

    Lyons Magnus LLC is recalling Ready Care Chocolate Shake Plus (4 oz) due to potential Listeria monocytogenes contamination. The recall affects 763,250 cases distributed to long-term care facilities, skilled nursing homes, and hospitals.

    Product
    Ready Care Chocolate Shake Plus (4 oz), UPC 10045796017471
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0281-2025·2025-03-26

    Dietary Supplement Tainted with Undeclared Sildenafil and Tadalafil

    Vitality male enhancement dietary supplement recalled nationwide. Product contains undeclared prescription drugs sildenafil and tadalafil not disclosed to consumers.

    Product
    Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1285-2025·2025-03-26

    Smiths Medical ProPort Plastic Venous Access System Recalled for Port Housing Separation Risk

    Smiths Medical is recalling certain ProPort Plastic Venous Access System devices due to a manufacturing defect that may cause the port housing and reservoir to separate.

    Product
    smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1284-2025·2025-03-26

    Smiths Medical ProPort Venous Access System Recalled for Port Separation Risk

    Smiths Medical is recalling ProPort Plastic Venous Access Systems due to a manufacturing defect that can cause the port housing and reservoir to separate. This may result in device failure affecting patients worldwide.

    Product
    smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0653-2025·2025-03-26

    Lyons Magnus chocolate shakes recalled due to potential Listeria contamination

    Two chocolate shake products from Lyons Magnus are being recalled due to potential Listeria monocytogenes contamination affecting approximately 763,250 cases distributed to healthcare facilities nationwide.

    Product
    Ready Care Chocolate Shake (4 oz), UPC 10045796017341; Imperial Chocolate Shake (4 oz), UPC 00074865926997
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0656-2025·2025-03-26

    Ready Care and Imperial Chocolate Shakes Recalled for Listeria Contamination Risk

    Lyons Magnus LLC is recalling Ready Care and Imperial Chocolate Shakes due to potential Listeria monocytogenes contamination. The recalled products were distributed nationwide to healthcare facilities and long-term care settings.

    Product
    Ready Care Chocolate Shake No Sugar Added (4 oz), UPC 10045796036335; Imperial Chocolate Shake No Sugar Added (4 oz), UPC 10734730244720
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0661-2025·2025-03-26

    Ready Care Strawberry Shake Recalled for Potential Listeria Contamination

    Lyons Magnus LLC is recalling Ready Care Strawberry Shake Plus (4 oz) due to potential Listeria monocytogenes contamination. The affected product has been distributed to healthcare facilities nationwide.

    Product
    Ready Care Strawberry Shake Plus (4 oz), UPC 10045796017495
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1288-2025·2025-03-26

    Smiths Medical ProPort Implantable Port Plastic Housing May Separate

    The ProPort Low Profile Plastic Venous Access System is being recalled because the port housing and port reservoir may separate due to a manufacturing defect, affecting approximately 2,236 units distributed worldwide.

    Product
    smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1277-2025·2025-03-26

    Smiths Medical ProPort venous access port may separate due to defect

    Smiths Medical is recalling ProPort Plastic Venous Access Ports. The plastic port housing and port reservoir may separate due to a manufacturing defect. The recall affects 3 units distributed worldwide.

    Product
    smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0655-2025·2025-03-26

    Vanilla Shake Products Recalled Due to Potential Listeria Contamination

    Lyons Magnus is recalling Ready Care and Imperial Vanilla Shake products for potential Listeria monocytogenes contamination. The affected products were distributed to healthcare facilities nationwide.

    Product
    Ready Care Vanilla Shake (4 oz), UPC 10045796017334; Imperial Vanilla Shake (4 oz), UPC 00074865926836
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0638-2025·2025-03-26

    Berry Buddies breakfast cups recalled for undeclared wheat and egg allergens

    Berry Buddies fruit-and-pancake cups are being recalled because the back label does not list wheat and eggs as allergens. People with allergies to these ingredients could have serious reactions.

    Product
    Berry Buddies; Blueberries, Mini Pancakes & Real Maple Syrup; NET WT 2.1 oz (60 g); 3-compartment non-flex plastic container with heat-sealed plastic film containing mini pancakes, blueberries, and maple syrup
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1282-2025·2025-03-26

    Smiths Medical ProPort Plastic Venous Access System recalled for port separation defect

    Smiths Medical is recalling its ProPort Plastic Venous Access System due to a manufacturing defect that may cause the plastic port housing and reservoir to separate, affecting 1,695 units distributed worldwide.

    Product
    smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1283-2025·2025-03-26

    Smiths Medical ProPort Plastic Implantable Ports Recalled for Port Housing Separation

    Smiths Medical is recalling 1961 units of ProPort Plastic Implantable Ports worldwide due to a manufacturing defect that may cause the port housing and reservoir to separate. This Class I recall affects patients dependent on venous access systems.

    Product
    smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0646-2025·2025-03-26

    Enoki Mushrooms Recalled Due to Listeria Monocytogenes Contamination

    Daily Veggies Enoki Mushroom from New Age International is being recalled because of Listeria monocytogenes contamination. Consumers who purchased this product should not consume it.

    Product
    Daily Veggies Enoki Mushroom; Product of Korea; Net WT. 200 g (7.05 oz); KEEP REFRIGERATED; Cook through before
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1280-2025·2025-03-26

    Smiths Medical ProPort Implantable Port Housing May Separate Due to Manufacturing Defect

    Smiths Medical is recalling 9,506 ProPort implantable venous access ports due to a manufacturing defect that may cause the port housing and reservoir to separate. No injuries have been reported.

    Product
    smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1286-2025·2025-03-26

    Smiths Medical ProPort Implantable Port May Separate Due to Manufacturing Defect

    Smiths Medical is recalling ProPort Plastic Venous Access Ports because the port housing and reservoir may separate due to a manufacturing defect. Contact your physician if you have an affected device.

    Product
    smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0657-2025·2025-03-26

    Strawberry Nutritional Shake Recalled Due to Listeria Contamination Risk

    Lyons Magnus is recalling Ready Care and Imperial brand Strawberry Shakes (No Sugar Added) due to potential Listeria monocytogenes contamination. The affected products were distributed to healthcare facilities nationwide.

    Product
    Ready Care Strawberry Shake No Sugar Added (4 oz), UPC 10045796017372; Imperial Strawberry Shake No Sugar Added (4 oz), UPC 00074865926843
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1287-2025·2025-03-26

    Smiths Medical ProPort Venous Ports Recalled for Potential Housing Separation

    Smiths Medical is recalling ProPort Low Profile Plastic Venous Access Systems because the plastic port housing and reservoir may separate due to a manufacturing defect. Approximately 8,515 units worldwide are affected.

    Product
    smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1278-2025·2025-03-26

    Smiths Medical ProPort Implantable Venous Ports Recalled for Separation Defect

    Smiths Medical has recalled 643 ProPort Plastic implantable venous access ports that may separate due to a manufacturing defect. The recall affects units distributed worldwide.

    Product
    smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1279-2025·2025-03-26

    Smiths Medical ProPort Implantable Port Component Separation Due to Manufacturing Defect

    Smiths Medical is recalling ProPort Plastic implantable port systems because the plastic port housing and port reservoir may separate due to a manufacturing defect. The recall affects 2,311 units distributed worldwide.

    Product
    smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0654-2025·2025-03-26

    Lyons Magnus Recalls Strawberry Shakes for Potential Listeria Contamination

    Lyons Magnus LLC is recalling Ready Care and Imperial Strawberry Shake products due to potential Listeria monocytogenes contamination. The recall affects 763,250 cases distributed to healthcare facilities.

    Product
    Ready Care Strawberry Shake (4 oz), UPC 10045796017358; Imperial Strawberry Shake (4 oz), UPC 00074865927017
    Category
    Food
    Distribution
    0 states