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.

8126–8150 of 88183

  • SevereFDA (Devices)·Z-1633-2025·2025-05-07

    GE Healthcare CARESTATION Anesthesia Systems Volume Control Ventilation Failure

    GE Healthcare CARESTATION anesthesia delivery systems may fail to provide effective ventilation in Volume Control Ventilation mode. Affected units can deliver ventilation through Pressure Control Ventilation modes or manual ventilation.

    Product
    GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1637-2025·2025-05-07

    GE Healthcare CARESTATION 750c A1 Anesthesia System Ventilation Defect

    GE Healthcare CARESTATION 750c A1 anesthesia systems may not provide effective ventilation in Volume Control Ventilation mode. Affected units can achieve ventilation through alternative modes or manual operation.

    Product
    GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1624-2025·2025-05-07

    GE Healthcare CARESTATION anesthesia systems ventilation malfunction recall

    GE Healthcare CARESTATION 620 A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Effective ventilation is available in Pressure Control or Manual ventilation modes.

    Product
    GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1631-2025·2025-05-07

    GE Healthcare Carestation Anesthesia Systems Ventilation Defect Recall

    Certain GE Healthcare Carestation anesthesia delivery systems may fail to provide effective ventilation in Volume Control Ventilation (VCV) mode. Affected systems can still be used safely in Pressure Control Ventilation or Manual ventilation modes.

    Product
    GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1638-2025·2025-05-07

    GE Healthcare CARESTATION Anesthesia Systems may not ventilate properly

    GE Healthcare is recalling certain CARESTATION anesthesia systems that may fail to provide effective ventilation in Volume Control Ventilation mode. Alternative ventilation modes remain functional.

    Product
    GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0396-2025·2025-05-07

    Levothyroxine Sodium Tablets 88 mcg Recall for Subpotency

    Accord Healthcare is recalling Levothyroxine Sodium Tablets 88 mcg (Lot D2300044, expiring 12/2025) nationwide because the tablets are subpotent—below the required strength. Patients on this medication should contact their pharmacy or prescriber.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1678-2025·2025-05-07

    Belmont 3.0 Liter Disposable Set Recalled for Cracked Female Connector

    Belmont Instrument LLC is recalling the 3.0 Liter Disposable Set (Model 903-00032) due to a potential crack in the female connector on the Heat Exchanger/patient line set that can cause fluid leaks during device priming.

    Product
    3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). The two components are packaged separately in individual pouches and placed in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0744-2025·2025-05-07

    Sundae Shoppe Cookies and Cream Mochi Ice Cream Recalled for Undeclared Wheat and Soy

    Gordon Desserts is recalling Sundae Shoppe Cookies and Cream Mochi Ice Cream due to undeclared wheat and soy allergens. The product was distributed to Connecticut, Virginia, Ohio, and Pennsylvania.

    Product
    Sundae Shoppe, Cookies and Cream Mochi Ice Cream, 6 count, 7.5 oz, Plastic sealed tray inside paper carton. 6 Pieces per carton, 8 cartons per shipper. Keep frozen.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1684-2025·2025-05-07

    epoc BGEM BUN Test Cards for Blood Analysis System Recalled

    Siemens Healthcare Diagnostics is recalling epoc BGEM BUN Test Cards (25 pk) due to discrepant high pH results when samples are introduced with higher injection volumes on affected sensor configurations.

    Product
    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0741-2025·2025-05-07

    Ancient Grains Hoagie Roll recalled for glass fragment contamination

    Upper Crust Bakery LP is recalling Ancient Grains Hoagie Rolls due to glass fragments found on the product surface. The affected frozen rolls were distributed to six states.

    Product
    Ancient Grains Hoagie Roll, 4 oz, Paper carton (corrugated), CP45, Frozen
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1714-2025·2025-05-07

    Medline Sterile Water and Saline Bottles Leaking at Seal Interface

    Medline is recalling sterile water and 0.9% normal saline bottles due to leaking at the peel-foil and bottle opening interface. The defect affects 159 units distributed nationwide and internationally.

    Product
    Medline procedure kits, labeled as: HAND, REF DYNJ902002J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0748-2025·2025-05-07

    Cookie Butter Banana Pie recalled for undeclared almond allergen

    Dianne's Fine Desserts is recalling Cookie Butter Banana Pie due to undeclared almonds. Consumers with almond allergies face risk of allergic reaction.

    Product
    Outer carton labeled: "Cookie Butter Banana Pie" Inner carton labeled: "Tropical Key Lime Pie" Product contained inside: "Cookie Butter Banana Pie" NET WT. 11 LB 2.8 OZ (5.06 kg) GROSS WT: 12.96 LB (5.88 kg)
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-1675-2025·2025-05-07

    Belmont Straight Inflow/Outflow Patient Line Kit recalled for potential connector crack

    Belmont Instrument LLC is recalling the Straight Inflow/Outflow Patient Line Kit (Model 902-00037) due to a potential crack in the female connector on the Heat Exchanger set that may cause fluid leaks during use.

    Product
    Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00037) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0759-2025·2025-05-07

    Emily Kate's Gluten Free Vanilla Cake recalled for foil contamination

    Emily Kate's Foods is recalling Emily Kate's Gluten Free Vanilla Cake (6.4 oz) due to foil found in cake slices. The affected product was distributed to a consignee in Wisconsin.

    Product
    Emily Kate's Gluten Free Vanilla Cake, Net Wt. 6.4oz, Emily Kate's Foods, Kansas City, KS 66106, UPC 850581007253
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0751-2025·2025-05-07

    Dinstuhl's Pecan Brittle recalled for undeclared milk allergen

    Dinstuhl's Fine Candy Company is recalling Dinstuhl's Pecan Brittle (4 oz. bags) because the product contains milk that is not declared on the label, posing a risk to consumers with milk allergies.

    Product
    Dinstuhl's Pecan Brittle, NET WT 4 oz. (113g), individually packaged in cellophane bags; Ingredients: Sugar, Pecans, Corn Syrup, Butter, Baking Soda, Salt, Vanilla.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0745-2025·2025-05-07

    Multigrain Sourdough Bread Recalled for Potential Glass Foreign Material

    Giant Eagle, Inc. is recalling Multigrain Sourdough Freshly Baked and Half Multigrain Sourdough Artisan Bread due to potential glass contamination. The recall affects 240 cases distributed to PA, OH, MD, IN, and WV.

    Product
    Multigrain Sourdough Freshly Backed, and Half Multigrain Sourdough Artisan Bread, 15 oz; 7 oz, Bag, 1 unit
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0750-2025·2025-05-07

    Dinstuhl's Peanut Brittle recalled for undeclared milk allergen

    Dinstuhl's Fine Candy Company is recalling Dinstuhl's Peanut Brittle (4 oz., UPC 7 68050 00205 3) because milk is not declared on the label, posing a risk to consumers with milk allergies.

    Product
    Dinstuhl's Peanut Brittle, NET WT 4 oz. (113g), individually packaged in cellophane bags; Ingredients: Sugar, Corn Syrup, Baking Soda, Peanuts, Butter, Pure Vanilla Extract.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0742-2025·2025-05-07

    Multigrain Sourdough Bread Recalled for Glass Fragment Contamination

    Upper Crust Bakery LP is recalling 18 oz packages of Multigrain Sourdough bread (Lot #90) because glass fragments have been found on top of the bread. The product was distributed to PA, CA, CT, MD, DE, and OH.

    Product
    Multigrain Sourdough , 18 oz, Paper carton (corrugated), CP12, Frozen
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1711-2025·2025-05-07

    Medline Wound Care and Laceration Procedure Kits Recalled for Leaking Bottles

    Medline is recalling Sterile Water and Sterile 0.9% Normal Saline bottles in wound care and laceration procedure kits due to leaking at the peel-foil and bottle opening interface.

    Product
    Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1673-2025·2025-05-07

    Stratus CS Acute Care cTNI TestPak cardiac troponin test recall

    Siemens Healthcare Diagnostics is recalling Stratus CS Acute Care cTNI TestPak, a cardiac troponin I test, due to an increased occurrence of false positive results during the product's shelf life.

    Product
    Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1672-2025·2025-05-07

    Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer Recall

    Beckman Coulter is recalling certain DxC 500 AU Clinical Chemistry Analyzers due to incorrect sample barcode identification and processing errors that can result in erroneous and delayed test results.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0758-2025·2025-05-07

    La Victoria Cilantro Salsa recalled for wood pieces in ingredient

    La Victoria Cilantro Salsa (15.5 oz) is being recalled because the fresh cilantro ingredient may contain wood pieces. The product was distributed to California, Nevada, Oregon, Washington, and Michigan.

    Product
    La Victoria Cilantro Salsa; Med; Net Wt 15.5 OZ; UPC# 0 72101 34470 3; Distributed by: Megamex Foods, LLC Orange, CA 92868
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0743-2025·2025-05-07

    Frozen Whole Grain Multigrain Bread Recalled for Glass Fragment

    Upper Crust Bakery LP is recalling frozen whole grain multigrain bread due to the presence of a glass fragment on the product. The affected 20 oz packages were distributed to PA, CA, CT, MD, DE, and OH.

    Product
    Whole Grain Multigrain , 20 oz, Paper carton (corrugated), CP12, Frozen
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0749-2025·2025-05-07

    Dinstuhl's Cashew Crunch Recalled for Undeclared Milk Allergen

    Dinstuhl's Fine Candy Company is recalling Dinstuhl's Cashew Crunch 4 oz. packages due to undeclared milk allergen. Consumers with milk allergies should not consume this product.

    Product
    Dinstuhl's Cashew Crunch, NET WT 4 oz. (113g), individually packaged in cellophane bags; Ingredients: Sugar, Cashews, Coconut, Corn Syrup, Brown Sugar, Butter, Salt, Baking Soda.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1661-2025·2025-05-07

    Trimble RTS873 Robotic Total Station Green Laser Safety Issue

    Trimble is recalling 127 RTS873 robotic total stations because the green aiming laser output power may exceed its Class 2 laser safety classification. Units were produced between October 2023 and February 12, 2025 and distributed in the US, South Korea, and United Kingdom.

    Product
    The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking precision, efficiency, and reliability in their layout tasks. The integrated Class 2 green aiming laser system enhances visibility and accuracy, even on uneven surfaces. It is…
    Category
    Medical Device
    Distribution
    0 states