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.

16826–16850 of 88183

  • SevereFDA (Devices)·Z-2434-2023·2023-09-06

    Cardiosave Rescue IABP Pumps Recalled for System Overheating and Pump Failure

    Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to system overheating alarms that can cause loss of pumping function and device shutdown.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1114-2023·2023-09-06

    Neonatal TPN Starter Bag recalled for sterility assurance concerns

    Central Admixture Pharmacy Services is recalling a neonatal TPN bag due to lack of validated sanitation cycles, affecting 84 units distributed nationwide.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0418-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2498-2023·2023-09-06

    Olympus Bronchovideoscope Recalled Due to Lodging Risk in Airway

    Olympus is recalling Bronchovideoscope Model BF-XT190 units because the device diameter is too large, causing the endoscope to become lodged in endotracheal tube connectors.

    Product
    Olympus Bronchovideoscope, Models BF-XT190.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2470-2023·2023-09-06

    Skytron GS70H Surgical Table Recall: Control Failure Causes Continued Movement

    The Skytron GS70H Salus Surgical Table may continue moving after the control button is released when operating in Bluetooth mode or when communication is interrupted. The defect could cause unexpected table movement during surgery.

    Product
    GS70H Salus Surgical Table, Product Code 18-071-70
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1475-2023·2023-09-06

    Moore Family Farms Cheddar Cheese Curds Recalled for E. Coli

    Moore Family Farms Creamery is recalling Cheddar Cheese Curds from Iowa due to potential E. coli and elevated coliform contamination. Consumers should not consume the product.

    Product
    Moore Family Farms and Creamery Cheddar Cheese Curds BLT, 1 lb plastic bag.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1136-2023·2023-09-06

    Vancomycin Injectable Recalled for Lack of Sterility Validation

    Central Admixture Pharmacy Services is recalling vancomycin injections nationwide (477 bags, lots 36-262215 and 36-262216) due to lack of validation data for sanitization cycles, which prevents assurance of product sterility.

    Product
    vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Excel Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1116-2023·2023-09-06

    Neonatal TPN IV bags recalled due to lack of sterility validation

    Central Admixture Pharmacy Services is recalling 200 neonatal TPN IV bags (lots 36-262872 and 36-262873, expiring 8/27/2023) distributed nationwide due to lack of validated sanitization procedures.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0406-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1120-2023·2023-09-06

    Neonatal Injectable Nutrition Bags Recalled for Lack of Sterility Validation

    Central Admixture Pharmacy Services is recalling 132 bags of neonatal injectable nutrition due to unvalidated sterilization processes. The lack of sterility assurance creates potential infection risk for neonatal patients receiving these products.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0429-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2482-2023·2023-09-06

    Medical Device Recall: Oculus Pentacam AXL Wave Measurement Inaccuracy

    Oculus Pentacam AXL Wave optical devices may have insufficient anti-reflective coating, potentially causing inaccurate axial length measurements used in eye surgery planning.

    Product
    Oculus Pentacam AXL Wave, Ref 70020, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1141-2023·2023-09-06

    Dianeal Peritoneal Dialysis Solution Recalled for Potential Sterility Compromise

    Baxter Healthcare is recalling Dianeal Low Calcium peritoneal dialysis solution due to potential leaks from the Luer component that could compromise sterility. The recall affects 22,112 bags nationwide.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1134-2023·2023-09-06

    OxyTOCIN IV Bags Recalled for Lack of Sterility Validation

    Central Admixture Pharmacy Services is recalling 298 bags of oxyTOCIN 40 units IV bags nationwide due to lack of validation data for sanitization cycles, creating potential sterility concerns.

    Product
    oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2493-2023·2023-09-06

    Olympus Bronchovideoscope Models Recalled for Endotracheal Tube Connector Lodging Risk

    Olympus is recalling 3,652 bronchovideoscope units nationwide due to complaints that the endoscope diameter is too large, creating a risk the scope may become lodged in the endotracheal tube connector.

    Product
    Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2502-2023·2023-09-06

    Olympus Bronchovideoscope Recalled Due to Oversized Diameter

    Olympus is recalling two models of bronchovideoscope (Models BF-3C40 and BF-N20) because the endoscope diameter is too large and may become lodged in the endotracheal tube connector.

    Product
    Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1483-2023·2023-09-06

    Trader Joe's Multigrain Crackers recalled due to metal contamination

    Treehouse Foods is recalling Trader Joe's Multigrain Crackers due to metal pieces found in the product. Consumers should discontinue use and contact the company.

    Product
    Trader Joe's Multigrain Crackers with Sunflower and Flax Seeds, 10oz (283g) box, UPC 000000761567, 24 retail boxes per wholesale case
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2492-2023·2023-09-06

    Olympus Bronchovideoscope Model BF-Q180-AC Recalled for Lodging Risk

    Olympus Corporation is recalling 416 units of the Bronchovideoscope Model BF-Q180-AC nationwide because the endoscope can become lodged in the endotracheal tube connector due to an oversized diameter.

    Product
    Olympus Bronchovideoscope, Model BF-Q180-AC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1133-2023·2023-09-06

    Injectable Oxytocin Recalled Due to Unvalidated Sterilization Process

    Central Admixture Pharmacy Services recalls oxytocin IV bags due to inadequate validation of sterilization, raising sterility concerns for this injectable.

    Product
    oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2496-2023·2023-09-06

    Olympus Bronchovideoscope Models Recalled Due to Lodgement Risk in Connectors

    Olympus is recalling 9,449 bronchovideoscope units nationwide due to complaints that the endoscope can become lodged in endotracheal tube connectors due to oversized diameter.

    Product
    Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1135-2023·2023-09-06

    FDA Recalls Heparin IV Bags Due to Lack of Sterility Validation

    Central Admixture Pharmacy Services is recalling 577 bags of heparin IV solution (2500 units/500mL) nationwide due to lack of validation data for sanitization cycles, which could compromise sterility assurance.

    Product
    heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1468-2023·2023-09-06

    Kraut and Kimchi Products Recalled Due to Temperature Control Failure

    C & S Wholesale Grocers Inc. is recalling fermented vegetable products sold at Stop & Shop in the New York Metro Region due to improper temperature storage. No illnesses have been reported.

    Product
    The following items sold at Stop & Shop stores located in the New York Metro Region: Cleveland Kraut Classic Cleveland Kraut Beets Kimchi Vegan Mild Cabbage
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-1129-2023·2023-09-06

    FDA Recalls EPINEPHrine IV Bags for Unvalidated Sterilization Processes

    Central Admixture Pharmacy Services is recalling 340 bags of epinephrine IV solution due to inadequate validation of sterilization procedures, creating a potential contamination risk.

    Product
    EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2487-2023·2023-09-06

    Intra-Aortic Balloon Pumps Fiber Optic Sensor Input Failure Recalled

    Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps because users reported failure of the fiber optic sensor input when inserting the balloon connector. This could affect proper device operation.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1469-2023·2023-09-06

    Mellow Mallow marshmallows recalled for undeclared soy and coconut allergens

    Mellow Mallow marshmallows are being recalled due to undeclared soy lecithin and coconut allergens. Consumers with allergies to these ingredients should not consume the affected product.

    Product
    Mellow Mallow packaged in 7oz cellophane wrappers.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2503-2023·2023-09-06

    Olympus Bronchovideoscope Recalled for Risk of Lodging in Airway Connector

    Olympus Corporation is recalling 1,004 units of the Bronchovideoscope Model BF-3C160 due to a dimensional defect that can cause the endoscope to become lodged in an endotracheal tube connector.

    Product
    Olympus Bronchovideoscope, Models BF-3C160.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1484-2023·2023-09-06

    Lyons Grape Juice recalled due to signs of bloating in packaging

    Lyons Magnus LLC is recalling Lyons Grape Juice in 4 fl oz plastic cups due to signs of bloating. The recall affects 1564 cases distributed across 13 states.

    Product
    Lyons Grape Juice packaged in 4 fl oz opaque white plastic cup 96 cups per case
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-2486-2023·2023-09-06

    Cardiosave Hybrid Intra-Aortic Balloon Pump Fiber Optic Sensor Failure

    Datascope Corp. is recalling 9,379 Cardiosave Hybrid Intra-Aortic Balloon Pumps due to a fiber optic sensor failure that may occur when inserting the balloon connector.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53…
    Category
    Medical Device
    Distribution
    Distributed nationwide