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.

15126–15150 of 27263

  • HighFDA (Devices)·Z-1271-2023·2023-09-06

    Atellica CH Triglycerides_2 Reagent Recalled Due to Magnesium Test Interference

    Siemens Healthcare Diagnostics is recalling 5,315 units of Atellica CH Triglycerides_2 diagnostic reagent due to reagent carryover that can affect magnesium test results. The product was distributed nationwide and internationally.

    Product
    Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum and plasma (lithium heparin, sodium heparin, potassium EDTA) using the Atellica CH Analyzer. SMN: 11537222
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1462-2023·2023-09-06

    Multiple Dressings and Dips Recalled for Improper Temperature Storage

    C & S Wholesale Grocers recalled multiple brands of dressings and dips sold at Stop & Shop stores in New York, New Jersey, and Connecticut. Products were not held at appropriate temperatures and may pose a contamination risk.

    Product
    The following items sold at Stop & Shop stores located in the New York Metro Region: Bolthouse Avocado Goddess Dressing Bolthouse Blue Cheese Dressing Bolthouse Caesar Dressing Bolthouse Cucumber Ranch Dressing Marzetti Light Ranch Veg Dip Marzetti French Onion Veg Dip Marzetti
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-1137-2023·2023-09-06

    Diltiazem IV Bag Recalled Due to Lack of Sterilization Assurance

    Central Admixture Pharmacy Services is recalling 235 bags of diltiazem IV product due to lack of validation data for sanitization cycles. No illnesses have been reported.

    Product
    dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2479-2023·2023-09-06

    PASCAL Transcatheter Valve Repair System Affected by Manufacturing Defect

    Edwards Lifesciences is recalling 92 units of the PASCAL Precision Transcatheter Valve Repair System due to a manufacturing defect in the release mechanism that could cause increased resistance and potential improper implant positioning.

    Product
    PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-1117-2023·2023-09-06

    Neonatal TPN Starter Bag Recalled Over Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 104 neonatal TPN starter bags (Lot 36-260022) due to lack of validation data for sanitization cycles, which could compromise sterility assurance in this IV medication.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043. NDC: 72196-0419-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2463-2023·2023-09-06

    SurgiCount+ Surgical Sponge Counting Software Miscounting Recalled

    Stryker Corporation is recalling the SurgiCount+ Software Application due to potential miscounting of surgical sponges when scanning multiple items from the same package. The software may fail to accurately track RFID-tagged absorbent articles.

    Product
    SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2465-2023·2023-09-06

    LifeSPARC Cardiac Pump Recalled Due to Uncured Epoxy Manufacturing Defect

    Cardiac Assist, Inc. is recalling the LifeSPARC Pump due to uncured epoxy used during manufacturing that may cause early device failure. Two units were distributed in Illinois and Florida.

    Product
    LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TAND
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1111-2023·2023-09-06

    Cardioplegia Solution Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services recalls Cardioplegia Solution due to inadequate validation of sterilization processes. One lot (36-262881) distributed nationwide may not be assured sterile.

    Product
    Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume = 1047 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1121-2023·2023-09-06

    Neonatal TPN IV Bags Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 92 bags of neonatal TPN IV bags (lot 36-262161) because of inadequate validation of manufacturing sanitization processes. The affected product was distributed nationwide.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0431-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1471-2023·2023-09-06

    Gummy Square Gummies Recalled for Undeclared Soy Lecithin

    Burning Acre is recalling Gummy Square gummies in .12oz packages due to undeclared soy lecithin, a major allergen. Consumers with soy allergies could experience allergic reactions.

    Product
    Gummy Square packaged in .12oz cellophane wrappers
    Category
    Food
    Distribution
    2 states
  • 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 (Drugs)·D-1113-2023·2023-09-06

    Rocuronium Injectable Drug Recalled Due to Sterility Assurance Failure

    The FDA is recalling rocuronium injectable syringes due to unvalidated sterilization processes. The product was distributed nationwide.

    Product
    rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2478-2023·2023-09-06

    Siemens epoc BGEM Test Card recalled for glucose measurement inaccuracy

    Siemens Healthcare Diagnostics is recalling epoc BGEM Test Cards for veterinary use due to potential inaccurate glucose results in lower-range samples. Affected units may report artificially elevated readings.

    Product
    epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Food)·F-1489-2023·2023-09-06

    Mehlenbacher's Taffy Peanut Butter Cup Recalled for Undeclared Milk Allergen

    Mehlenbacher's Taffy peanut butter cup pieces are recalled due to undeclared milk allergen. The product may pose a risk to consumers with milk allergies.

    Product
    Mehlenbacher's Taffy, 1.25 oz per piece, 36 pieces/box, cello wrapped. Peanut butter cup, UPC 022099174080. Storage in a cool dry place.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2500-2023·2023-09-06

    Olympus Bronchovideoscope Models Risk Device Lodging in Airway

    Olympus Corporation is recalling 3,949 Bronchovideoscope units nationwide because the endoscope diameter is too large, causing potential lodging in endotracheal tube connectors.

    Product
    Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1122-2023·2023-09-06

    Neonatal TPN Nutrition Bags Recalled for Sterility Validation Deficiency

    Central Admixture Pharmacy Services recalled 108 bags of neonatal TPN solution (Lot 36-260017, expires 8/19/2023) due to insufficient validation data for sterilization cycles. The product was distributed nationwide.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0422-1
    Category
    Drug
    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-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 (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-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 (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-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 (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 (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 (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