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.

6726–6750 of 26961

  • 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 (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 (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-0662-2025·2025-03-26

    Ready Care Vanilla Shake Plus 4 oz Recalled for Listeria Contamination

    Lyons Magnus LLC is recalling Ready Care Vanilla Shake Plus (4 oz, UPC 10045796017549) due to potential contamination with Listeria monocytogenes. The product was distributed to hospitals, nursing homes, and long-term care facilities across the United States.

    Product
    Ready Care Vanilla Shake Plus (4 oz), UPC 10045796017549
    Category
    Food
    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-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
  • HighFDA (Devices)·Z-1363-2025·2025-03-26

    Medline Proxima sterile surgical drapes recalled due to potential packaging breach

    Medline is recalling 1,482 units of Proxima sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. No illnesses have been reported.

    Product
    Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,SPLIT,CVMAX,6/CS; DRAPE,ORTHOMAX ,BAR,6/CS; DRA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1406-2025·2025-03-26

    Cranial Surgery Procedure Kit Recalled Over Sterility Assurance Failure

    American Contract Systems Inc is recalling 91 CRANI PACK cranial procedure kits because a critical component cannot be confirmed to meet sterility requirements, making them unsuitable for surgical use.

    Product
    CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0641-2025·2025-03-26

    Shredded Colby Jack cheese recalled for potential stainless steel fragments

    Great Lakes Cheese Co is recalling Happy Farms by ALDI Colby Jack shredded cheese due to potential stainless steel fragments. Affected products have best-by dates of July 13 or July 14, 2025.

    Product
    Happy Farms by ALDI Colby Jack (a blend of Colby & Monterey Jack finely shredded cheeses), Net Wt. 12 OZ (340g), packaged in flexible plastic stand-up pouches, 12 pouches per case, UPC 4061463330840, with Best By dates of July 13, 2025 and July 14, 2025. Dist. & sold exclusively
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1383-2025·2025-03-26

    Microstream CO2 Sampling Line May Not Disconnect From Intubation Tube

    Microstream intubated CO2 sampling lines may be difficult or impossible to disconnect from endotracheal tubes. This could delay necessary procedures and cause unintended extubation, potentially leading to respiratory failure.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric Intubated CO2 Sampling Line 2m/6.5ft Short-term use: Procedural/Emergency, MLAI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0639-2025·2025-03-26

    Domna's Bakery Baklava Recalled for Undeclared Milk Allergen

    Optima Foods is recalling Domna's Bakery 24 PC Baklava Tray distributed in New York because it contains undeclared milk. Consumers with milk allergies should not consume this product.

    Product
    Domna's Bakery 24 PC Baklava Tray 330043 8
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1404-2025·2025-03-26

    CAPNOCHECK BCI Airway Adapter may break off, causing ventilation failure

    The CAPNOCHECK BCI Airway Adapter (Model BSR) may break when attached to a valve or tube, risking airway circuit failure and loss of ventilation. Approximately 175,994 units were recalled nationwide.

    Product
    CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0649-2025·2025-03-26

    Chocolate Peanut Butter Protein Balls Recalled for Undeclared Allergens and Food Additives

    Prep'd CDA LLC is recalling Chocolate Peanut Butter Protein Balls due to undeclared soy lecithin and undeclared food color additives. Consumers with soy allergies should not consume the product.

    Product
    Chocolate Peanut Butter Protein Balls. Product has expected life of 2 weeks and does not require refrigeration. Product is packaged in sets of 2 protein balls into resealable plastic baggies. Net Wt. 78 grams.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1355-2025·2025-03-26

    Neuro IR Tray recalled over unconfirmed sterilization assurance

    American Contract Systems Inc is recalling Neuro IR Tray (Model WENI56J) due to inability to confirm sterilization assurance. Loss of functionality could delay or prolong treatment.

    Product
    NEURO IR TRAY , Model No WENI56J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2025·2025-03-26

    Open Heart Surgery Kit Sterilization Assurance Cannot Be Confirmed

    American Contract Systems Inc is recalling 90 Open Heart Adult Side A surgical kits due to inability to confirm sterilization requirements were met. Unsterilized devices could lose functionality and delay patient treatment.

    Product
    OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0650-2025·2025-03-26

    Chef's Line Black Bean Burgers Recalled for Foreign Object

    Chef's Line US Foods black bean burgers are being recalled because a bolt was found in the product. The recalled product was distributed to Illinois, Maryland, New Jersey, Pennsylvania, and Delaware.

    Product
    Chef's Line US Foods, Black Bean Burger, 36/4.25 oz., Product in a plastic bag in a cardboard box. approx. 36 pieces per case. Keep Frozen,
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1341-2025·2025-03-26

    Birth Delivery Kit Recalled Due to Unconfirmed Sterilization Assurance

    American Contract Systems Inc recalls the Born on Arrival Kit due to inability to confirm sterilization assurance. Unsterilized equipment could delay or prolong newborn treatment.

    Product
    BORN ON ARRIVAL KIT , Model No LLBN11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1338-2025·2025-03-26

    Labor and Delivery Pack Recalled Over Unconfirmed Sterilization

    American Contract Systems is recalling 725 Labor & Delivery Packs because the manufacturer cannot confirm sterilization requirements were met. Devices may lack functionality and could delay or prolong patient treatment.

    Product
    LABOR & DELIVERY PACK, Model Nos LLLD19H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0283-2025·2025-03-26

    Walgreens Acne Cream Recalled for Benzene Contamination

    Walgreens Maximum Strength Tinted Acne Treatment Cream is being recalled for benzene contamination. The product was distributed nationwide; affected consumers should stop use immediately.

    Product
    Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton; Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1407-2025·2025-03-26

    Synapse PACS Software incorrect patient age calculation for infants

    FUJIFILM's Synapse PACS Software versions 7.4.x incorrectly calculates patient age for infants under 3 months, potentially affecting clinical decisions. 104 units recalled in US and internationally.

    Product
    Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1375-2025·2025-03-26

    BD Pyxis Medication Dispensing Systems Software Sync Error Recall

    BD Pyxis medication dispensing systems may disconnect from their server due to a software error, preventing them from receiving medication updates. This could lead to incorrect medication administration or delayed access to medications.

    Product
    BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01,
    Category
    Medical Device
    Distribution
    Distributed nationwide