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.

6626–6650 of 88183

  • CriticalFDA (Food)·H-0545-2025·2025-08-20

    Molly's Kitchens tuna salad recalled for Listeria risk from recalled breadcrumbs

    Molly's Kitchens Tuna Salad in 5 lb foodservice tubs, distributed by US Foods, is recalled for potential Listeria monocytogenes contamination from recalled Newly Weds Foods breadcrumbs. 1,136 cases are affected.

    Product
    Molly's Kitchens Tuna Salad, item 794599, net wt. 5lb. Foodservice item. Product is packaged in clear printed plastic tub with printed white lid. Keep Refrigerated. Distributed by U.S. Foods, Inc, Rosemont, IL. UPC on 5lb. TUB/Lid: 58108 76447 GTIN on Master Case (2/5# per…
    Category
    Food
    Distribution
    29 states
  • CriticalFDA (Food)·H-0544-2025·2025-08-20

    Reser's tuna salad containing pickle relish recalled for Listeria monocytogenes risk

    Reser's Tuna Salad in 5 lb foodservice tubs, the version containing pickle relish, is recalled for potential Listeria monocytogenes contamination from recalled breadcrumbs. 108 cases are affected.

    Product
    Reser's Tuna Salad, net wt. 5lb. Foodservice item. Product is packaged in white plastic tub and lid with sticker. Keep Refrigerated. This item contains ingredient Pickle Relish. Distributed by Reser's Fine Foods, Incl, Beaverton, OR. UPC on 5lb. TUB/Lid: 71117 11405 GTIN on…
    Category
    Food
    Distribution
    29 states
  • CriticalFDA (Food)·H-0536-2025·2025-08-20

    Colombian fresh cheese recalled over insanitary conditions and possible Listeria contamination

    Quesito El Establo brand Quesito Colombiano, 1 lb, is recalled because it was made and held under insanitary conditions and may be contaminated with Listeria monocytogenes. All product codes are affected.

    Product
    Quesito El Establo brand Spanish Cheese QUESITO COLOMBIANO; INGREDIENTS: Milk, Cheese Cultures, Salt, Vitamins C and D; INGREDIENTES: Leche, Cuajo, Sal, Vitaminas C y D; NET WT. 1 LB.; KEEP REFRIGERATED
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·H-0473-2025·2025-08-20

    Ready Meals duo tuna salad with crackers recalled over Listeria risk

    Ready Meals Duo Tuna Salad with Crackers is being recalled because of potential contamination with Listeria monocytogenes. The source does not state a quantity.

    Product
    READY MEALS DUO TUNA SALAD W/ CRACKERS
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2228-2025·2025-08-20

    DreamStation Auto BiPAP units may hold an incorrect device configuration

    DreamStation Auto BiPAP non-continuous ventilators are being recalled because the devices may possess a programming error resulting in an incorrect device configuration. 8 units are affected.

    Product
    DreamStation Auto BiPAP. Non-Continuous Ventilator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2227-2025·2025-08-20

    DreamStation Auto CPAP units may hold an incorrect device configuration

    DreamStation Auto CPAP non-continuous ventilators are being recalled because the devices may possess a programming error resulting in an incorrect device configuration. 57 units are affected.

    Product
    DreamStation Auto CPAP. Non-Continuous Ventilator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0541-2025·2025-08-20

    Reser's gourmet tuna salad recalled over Listeria in recalled breadcrumbs

    Reser's Gourmet Tuna Salad, 5 lb foodservice tubs, is being recalled because it contains Newly Weds Foods recalled Japanese style breadcrumbs, with potential Listeria monocytogenes contamination. 240 cases affected.

    Product
    Reser's Gourmet Tuna Salad, net wt. 5lb. Foodservice item. Product is packaged in clear printed plastic tub with white lid with white sticker. Keep Refrigerated. Distributed by Reser's Fine Foods, Beaverton, OR. UPC on 5lb. TUB: 71117 85506 GTIN on Master Case (2/5# per…
    Category
    Food
    Distribution
    29 states
  • SevereFDA (Food)·H-0539-2025·2025-08-20

    Signature Cafe tuna salad recalled over Listeria in recalled breadcrumbs

    Signature Cafe Premium Tuna Salad, 3 lb foodservice tubs, is being recalled because it contains Newly Weds Foods recalled Japanese style breadcrumbs, with potential Listeria monocytogenes contamination. 165 cases affected.

    Product
    Signature Cafe Premium Tuna Salad, net wt. 3lb (48oz). Foodservice item to be used by deli. Product is packaged in clear plastic tub with printed white lid. Keep Refrigerated. Distributed by Lucerne Foods, PO Box 99, Pleasanton, CA. UPC on 3lb. TUB: 71117 06036 GTIN on…
    Category
    Food
    Distribution
    29 states
  • SevereFDA (Devices)·Z-2291-2025·2025-08-20

    HeartMate mobile power unit cords may disconnect from a misaligned lock

    HeartMate Mobile Power Units are being recalled because misaligned V-Lock features on the power cords prevent the locking mechanism engaging properly and may cause unintended disconnect. 604 units affected.

    Product
    Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2293-2025·2025-08-20

    High pressure tubing may separate and trap air in the line

    High Pressure Tubing is being recalled because it may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 8,040 units affected.

    Product
    High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0471-2025·2025-08-20

    Choco-dipped mini paletas recalled because label lists cream but omits milk

    Helados Mexico Choco-Dipped Minis Variety Paletas, 12-count 18 oz, are recalled nationwide because the label lists cream without declaring milk as its source. 42,564 units are affected.

    Product
    Helados Mexico Choco-Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-81215-5 UPC: 6-82082-41215-7
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0501-2025·2025-08-20

    Frozen oyster meat recalled over potential norovirus contamination in California distribution

    Frozen Oyster Meat (IQF) under lot B250206 is recalled because it is potentially contaminated with norovirus. The recall covers 180 cartons sent to distributors and supermarkets in Southern California.

    Product
    Frozen Oyster Meat (IQF), Cert No. KR-15-SP; Processor Name: JBR KR-15-SP; Harvest Date: Feb 06, 2025 Shucked Date: Feb 07,2025 Expiration: 02/06/2027 UPC: 8809366955717
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0461-2025·2025-08-20

    Bubble gum paletas recalled because label lists cream without naming milk

    La Michoacana Bubble Gum Single Serve Paletas, 3.75 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 12,163 units are affected.

    Product
    La Michoacana Bubble Gum Single Serve Paleta 3.75oz UPC: 7-67778-00003-7
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2025·2025-08-20

    Custom manifold kit tubing may separate and trap air in line

    Custom Manifold Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 6,327 units affected.

    Product
    Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0494-2025·2025-08-20

    Green Reviver juice distributed unpasteurized in violation of juice HACCP rules

    Green Reviver Juice is being recalled because the firm manufactured and distributed unpasteurized juice products to retailers in violation of the Juice HACCP regulations. 1,932 bags are affected.

    Product
    FG60007 Green Reviver Juice - point of service product
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2297-2025·2025-08-20

    3mensio workstation clock measurements may place stent graft fenestrations incorrectly

    3mensio Workstation (Vascular Fenestrated) software is being recalled because changing the 12h position of a single clock does not update other clock measurements, which may place stent graft fenestrations incorrectly. 501 units affected.

    Product
    3mensio Workstation (Vascular Fenestrated) software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2278-2025·2025-08-20

    FARAWAVE ablation catheters may have cracks in the distal electrode bands

    FARAWAVE 1.0 Pulsed Field Ablation Catheters are being recalled because specific manufacturing equipment may have caused cracks in the electrode bands on the catheter's distal end. 445 units affected.

    Product
    FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0499-2025·2025-08-20

    Clover Valley instant coffee may contain glass pieces in jars

    Clover Valley Instant Coffee in 8 oz glass jars is being recalled because of the potential presence of glass pieces. 84,240 units are affected.

    Product
    Clover Valley Instant Coffee, NET WT 8 OZ (227 g), packaged in a glass jar, packed 6 jars per case, UPC: 876941004069, Distributed By Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072
    Category
    Food
    Distribution
    48 states
  • HighFDA (Food)·H-0455-2025·2025-08-20

    Quinoa chia soda biscuits recalled for undeclared whole milk powder and wheat

    Soda Biscuit (Quinoa Chia Seed Flavor), 360 g packages imported by Shang Hao Jia, Inc., is recalled because the label does not declare whole milk powder and wheat. 4,800 units are affected.

    Product
    Soda Biscuit (Quinoa Chia Seed Flavor), Net Wt: 360g/12.07oz; Shelf life: 10 months; Manufacturer: Zhejiang Dinggian Industrial Co., Ltd. Importer: Shang Hao Jia., Inc. UPC: 6 970425 865048
    Category
    Food
    Distribution
    1 state