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.

6701–6725 of 26961

  • HighFDA (Devices)·Z-1447-2025·2025-04-02

    Medline procedure kits recalled for syringe quality defects

    Medline Industries is recalling 1,711 procedure kits containing plastic syringes affected by manufacturing defects. The syringes may leak or break, posing a risk to patient safety during medical procedures.

    Product
    Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2) CSMC/GYN LAPAROSCOPIC PACK-LF, Pack Number DYNJ0665103I; 3) DAVINCI PACK-RFD, Pack Number DYNJ47762O; 4) DAVINCI ROBOT PACK SLRMC, Pack Number DYNJ81236; 5) GENERAL ROBOTICS PACK, Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0298-2025·2025-04-02

    Babyganics Mineral Sunscreen Recalled for Failed Stability Specifications

    Babyganics Sheer Blend SPF 50 Mineral Sunscreen is being recalled nationwide because ingredients separated during stability testing, prompting an FDA Class II recall.

    Product
    babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0302-2025·2025-04-02

    Topical Hydrogen Peroxide Solution Recalled for Incorrect Back Label

    Consumer Product Partners is recalling Hydrogen Peroxide Topical Solution bottles with incorrect back labels indicating 91% Isopropyl Alcohol. The labeling mixup affects 25,932 bottles distributed in Virginia.

    Product
    HYDROGEN PEROXIDE — HYDROGEN PEROXIDE (HYDROGEN PEROXIDE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0668-2025·2025-04-02

    Dried Lily Flowers Recalled Due to Undeclared Sulfites

    U.S. Trading Company recalled dried lily flowers due to undeclared sulfites, which pose a risk to people with sulfite sensitivity. The recall affected 5,200 packages distributed across 32 states and was terminated July 1, 2025.

    Product
    DRIED LILY FLOWERS Net Weight 2.5 oz (70g) Ingredients: Lily flower (Hemerocallis citrina) Distributed by: U.S. TRADING COMPANY Hayward, CA 94545-1130 Product of China
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-1433-2025·2025-04-02

    NexGen LPS Flex knee prosthesis recalled for labeling inconsistency

    Zimmer recalls 76 NexGen LPS Flex knee prosthesis units due to conflicting plate compatibility information on the product label.

    Product
    NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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 (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 (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
  • ModerateFDA (Food)·F-0671-2025·2025-04-02

    Dietary Supplement Recalled for Iodine Content Exceeding Label Claims

    Veridance Pharmacal is recalling 450 bottles of Omni-Macs McDonagh Medical Center Dietary Supplement because iodine levels exceed what is claimed on the label. One customer in Gladstone, Missouri received the affected product.

    Product
    Omni-Macs McDonagh Medical Center Dietary Supplement 100 CAPSULES, Suggested Use: 1-3 capsules per day with meals, Distributed by: McDonagh Medical Center Gladstone, MO 64119
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1434-2025·2025-04-02

    Prelude IDEAL 4F Hydrophilic Sheath Introducer contains incorrect 5F dilators

    Merit Medical Systems is recalling Prelude IDEAL 4F Hydrophilic Sheath Introducer units (Lot H3082668) that contain 5F dilators instead of the labeled 4F dilators, which may result in procedure delay.

    Product
    Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
    Category
    Medical Device
    Distribution
    0 states
  • 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-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 (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 (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-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-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-0658-2025·2025-03-26

    Ready Care and Imperial Shakes Recalled for Listeria Contamination Risk

    Ready Care and Imperial Strawberry Banana Shakes are being recalled due to potential Listeria monocytogenes contamination. The affected products were distributed to long-term care facilities, hospitals, and nursing homes.

    Product
    Ready Care Strawberry Banana Shake No Sugar Added (4 oz), UPC 10045796018447; Imperial Strawberry Banana Shake No Sugar Added (4 oz), UPC 00074865987325
    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-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 (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-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