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.

7676–7700 of 26961

  • SevereFDA (Food)·F-0378-2025·2025-01-15

    Greek yogurt tzatziki products recalled for potential salmonella

    US Foods Chef's Line and Nick The Greek tzatziki products distributed across multiple states are being recalled due to potential salmonella contamination. Consumers should not consume these products.

    Product
    US Foods Chef's Line Greek Yogurt Tzatziki 4lbs tub, UPC 758108679962, SKU SAL519448, 2 tubs per case. Nick The Greek Tzatziki Pail, 42lbs pail, UPC 10075365177787, SKU SA000084
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Drugs)·D-0181-2025·2025-01-15

    Clonazepam Tablets Recalled Due to Carton Labeling Error

    Endo USA, Inc. is recalling 22,513 cartons of clonazepam tablets due to incorrect strength labeling on some carton exteriors. The actual tablets inside have correct labeling.

    Product
    CLONAZEPAM — CLONAZEPAM (CLONAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0178-2025·2025-01-15

    Clonazepam tablets recalled for incorrect carton labeling

    Endo USA is recalling approximately 9,816 cartons of Clonazepam 2 mg tablets due to incorrect strength labeling on the carton exterior. The blister strips inside contain the correct formulation.

    Product
    CLONAZEPAM — CLONAZEPAM (CLONAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0177-2025·2025-01-15

    Herbal Capsules Recalled Nationwide for Undeclared Pharmaceutical Ingredients

    Herbal capsules sold nationwide have been recalled after the FDA found undeclared medications inside. The product contained furosemide, dexamethasone, and chlorpheniramine without proper labeling.

    Product
    Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang, Malasia.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0763-2025·2025-01-15

    Large Volume Pump model LVP-0004 recalled for potential pneumatic valve failure

    Fresenius Kabi is recalling 1,520 Ivenix infusion pumps (model LVP-0004) due to potential pneumatic valve failure that may stop active infusions or prevent pump operation. Affected units were distributed to healthcare facilities in six U.S. states.

    Product
    Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0711-2025·2025-01-15

    VasoView HemoPro 2 Endoscopic Vessel Harvesting System Class I Recall

    FDA recalls VasoView HemoPro 2 endoscopic vessel harvesting systems due to risk of heater wire detachment and silicone peeling from the harvesting tool jaws, which could affect device function.

    Product
    VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0380-2025·2025-01-15

    Olympia Foods Grecian Dip Tzatziki Sauce Recalled for Salmonella Risk

    Olympia Foods has recalled Grecian Dip Tzatziki sauce due to potential Salmonella contamination. Consumers should not consume affected products and should check lot codes before use.

    Product
    Olympia Foods Grecian Dip Tzatziki sauce, item 100, 4 lb. tubs, UPC 10045059001001, 4 tubs per case; item 104, 32lbs pail, UPC 00045059001042
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Food)·F-0385-2025·2025-01-15

    Texas Harvest Cucumbers Recalled for Potential Salmonella Contamination

    Dairyland Produce is recalling 4 cases of Texas Harvest cucumbers due to potential Salmonella contamination. Consumers should not consume the affected product.

    Product
    Texas Harvest Product: 01035 Cucumber Sliced 5# 5-pound trays with sealed film
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0712-2025·2025-01-15

    Vasoview Hemopro 2 Vessel Harvesting System Recalled for Heater Wire and Silicone Defects

    Maquet Cardiovascular is recalling the Vasoview Hemopro 2 Vessel Harvesting System due to potential heater wire and silicone defects. These could affect device function during minimally invasive surgery.

    Product
    Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0379-2025·2025-01-15

    Spicy Yogurt Pails Recalled for Potential Salmonella Contamination

    Grecian Delight/Kronos is recalling Nick The Greek Spicy Yogurt Pails (Lot 4305) due to potential salmonella contamination. The 42-lb pails were distributed across 27 U.S. states.

    Product
    Nick The Greek Spicy Yogurt Pail, 42lbs pail, UPC 10075365177756, SKU SA000085
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0802-2025·2025-01-15

    VACUETTE SAFELINK Blood Collection Holder May Leak Due to Defective Sleeve

    Greiner Bio-One GmbH is recalling VACUETTE SAFELINK blood collection holders because the protective rubber sleeve may bunch up and fail to retract, causing potential blood leakage from the device.

    Product
    VACUETTE SAFELINK, REF: 450210
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0813-2025·2025-01-15

    Medical radiographic system arm drop hazard due to missing safety bolts

    GE Healthcare Optima XR240amx systems with column replacement may have missing bolts in the Column Safety mechanism. If these bolts are missing and the counterpoise cable fails, the X-ray arm could drop.

    Product
    GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-41; 5) 5555000-47; 6) A0700DL; 7) A1700DA; 8) To be provided.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0810-2025·2025-01-15

    Xhibit Telemetry Receiver software versions may cause unsolicited system shutdowns

    Telemetry receivers with affected software versions may unexpectedly shut down for 1-1.5 minutes, temporarily disabling patient monitoring. This could delay clinical response if a patient event occurs during the outage.

    Product
    Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Drugs)·D-0189-2025·2025-01-15

    Duloxetine Delayed-Release Capsules Recalled for Manufacturing Impurity Above Safe Limits

    Rising Pharma is recalling 73,680 bottles of Duloxetine 20 mg capsules nationwide due to N-nitroso-duloxetine impurity above recommended limits from manufacturing deviations. No illnesses have been reported.

    Product
    Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0804-2025·2025-01-15

    Smaxel Fractional CO2 Laser recalled for missing safety label and instructions

    IDS LTD is recalling 23 Smaxel Fractional CO2 Laser systems worldwide due to missing Certification label and inadequate instructions for safe operation.

    Product
    Smaxel Fractional CO2 Laser, a Class IV medical laser system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0816-2025·2025-01-15

    Tec 820 SEV Anesthesia Vaporizer Recalled for Inadequate Anesthetic Delivery

    GE Medical Systems is recalling approximately 928 Tec 820 SEV anesthesia vaporizers due to a manufacturing defect that can cause them to deliver less anesthetic agent than the dial setting indicates. The devices are distributed nationwide and globally.

    Product
    Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0381-2025·2025-01-15

    Chow Ciao Breaded Broccoli Nuggets Recalled for Metal Contamination

    Better Brands Inc. recalls Chow Ciao Whole Grain Breaded Broccoli Nuggets due to metal contamination. Lot 24241 from 08/27/2024 affects 168 cases.

    Product
    Chow Ciao Whole Grain Breaded Broccoli Nuggets - 30 lbs.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0192-2025·2025-01-15

    Metformin ER 500 mg tablets recalled due to foreign tablet contamination

    Granules Pharmaceuticals is recalling Metformin ER 500 mg tablets due to discovery of a Paracetamol tablet in one bottle. Patients taking the affected lot should verify their medication with their pharmacy.

    Product
    METFORMIN ER 500 MG — METFORMIN ER 500 MG (METFORMIN ER 500 MG)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0817-2025·2025-01-15

    GE Tec Anesthesia Vaporizers Recalled for Insufficient Anesthetic Delivery

    Certain GE Tec anesthesia vaporizers (Tec 6 Plus and Tec 800 series) may deliver less anesthetic agent than the dial indicates due to a manufacturing issue. Users should cease use and contact GE Medical for instructions.

    Product
    Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0382-2025·2025-01-15

    Connie's Classic Thin Crust Cheese Pizza Recalled for Plastic Contamination

    Palermo Villa, Inc is recalling Connie's Classic Thin Crust Cheese Pizza due to the presence of plastic in the product. The affected frozen pizzas were distributed in Illinois, Minnesota, and Wisconsin.

    Product
    Connie's Classic Thin Crust Cheese Pizza, Chicago's Finest. Net Wt 20.36 oz. (1lb 4.36 oz) 577g. UPC 0 75706-19104 8. Keep Refrigerated. Distributed by: Palermo Villa, nc. Milwaukee, WI 53208.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0811-2025·2025-01-15

    Mobile Radiographic System Arm May Drop Due to Missing Safety Bolts

    GE Healthcare Optima XR200amx mobile radiographic systems may have missing bolts in the Column Safety mechanism, which could allow the X-ray arm to drop if an internal cable fails.

    Product
    GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0819-2025·2025-01-15

    AMT Mini Enteral Extension Set Recalled for Incorrect Connector Type

    Applied Medical Technology is recalling AMT Mini Enteral Extension Sets due to incorrect ENFit connector type. Affected units have ENFit connections instead of non-ENFit, preventing proper compatibility with intended systems.

    Product
    AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0814-2025·2025-01-15

    Anesthesia Vaporizers May Deliver Less Anesthetic Than Dial Setting Due to Manufacturing Defect

    Certain Tec 6 Plus and Tec 800 series anesthesia vaporizers may deliver less anesthetic agent than the dial setting indicates due to a manufacturing issue. Approximately 1,573 units are affected, distributed in the United States and globally.

    Product
    Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-001, 2091009-001, M1098876, M1145610, M1220023, M1220854, M122
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0187-2025·2025-01-15

    Colchicine Capsules Recalled Due to Failed Dissolution Specifications

    Granules Pharmaceuticals is recalling Colchicine 0.6 mg capsules nationwide due to failed dissolution specifications detected during stability testing. Patients should contact their healthcare provider for guidance.

    Product
    COLCHICINE — COLCHICINE (COLCHICINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0803-2025·2025-01-15

    Beckman Coulter PTH Assay Reagent Packs Recalled for Filling Defects

    Beckman Coulter is recalling Access PTH assay reagent packs from lot 339071 due to under- or over-filling in well 0, which could cause sealing issues, contamination, and inaccurate test results.

    Product
    Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems, Catalog Number A16972
    Category
    Medical Device
    Distribution
    Distributed nationwide