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.

15151–15175 of 27263

  • 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 (Devices)·Z-2471-2023·2023-09-06

    Laboratory diagnostic test may produce inaccurate results from reagent carryover

    Siemens is recalling the Atellica CH Total Bilirubin diagnostic test because reagent carryover on the analyzer could produce falsely elevated results affecting multiple related lab tests.

    Product
    Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1124-2023·2023-09-06

    Phenylephrine Injectable Syringes Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 4,100 syringes of phenylephrine injectable solution due to inadequate validation of sterilization cycles. The lack of documented sterilization assurance creates potential for microbial contamination.

    Product
    PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1123-2023·2023-09-06

    Cardioplegia Solution Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services recalls Cardioplegia Solution due to lack of validation data for sanitization cycles, which cannot assure product sterility.

    Product
    CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1
    Category
    Drug
    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 (Devices)·Z-2477-2023·2023-09-06

    FDA Recalls Siemens epoc BGEM Crea Test Cards for Inaccurate Glucose Results

    Siemens Healthcare is recalling epoc BGEM Crea Test Cards that may produce inaccurate glucose readings in lower-range samples. 473 units were distributed to US facilities and international locations. No injuries reported.

    Product
    epoc BGEM Crea Test Card 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-1470-2023·2023-09-06

    Peanut Butter Mellow Mallow Recalled for Undeclared Soy and Coconut Allergens

    BURNING ACRE recalled Peanut Butter Mellow Mallow 7-ounce packages due to undeclared soy lecithin and coconut allergens. The affected product was distributed in Georgia and Tennessee.

    Product
    Peanut Butter Mellow Mallow packaged in 7oz cellophane wrappers.
    Category
    Food
    Distribution
    2 states
  • 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-1474-2023·2023-09-06

    Moore Family Farms Cheddar Cheese Curds Loaded Baked Potato Recalled for E. coli

    Moore Family Farms Creamery is recalling Cheddar Cheese Curds Loaded Baked Potato (1 lb bags) from Iowa due to possible E. coli and coliform contamination.

    Product
    Moore Family Farms and Creamery Cheddar Cheese Curds Loaded Baked Potato, 1 lb plastic bag.
    Category
    Food
    Distribution
    1 state
  • 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-2468-2023·2023-09-06

    Chevalier Valvulotome Surgical Instrument Recalled Due to Burr Defect

    LeMaitre Vascular is recalling certain Chevalier Valvulotome surgical instruments used in vein-graft procedures due to burrs on the cutting tip that may tear the harvested vein. The recall affects 225 units distributed internationally.

    Product
    The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulotome consists of a 70 cm stainless steel shaft with two tips: 1) the cutting tip is shaped like an invert
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2473-2023·2023-09-06

    Diagnostic reagent kit recall: potential test result inaccuracy

    Siemens is recalling Atellica CH diagnostic reagent kits due to potential reagent carryover that could produce inaccurate test results. This may affect quality control and patient test reliability.

    Product
    Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test Code: GGT Siemens Material Number (SMN): 11097597
    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 (Drugs)·D-1128-2023·2023-09-06

    Phenylephrine IV Injection Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services recalls phenylephrine IV bags nationwide because the manufacturer lacks validated sanitization data to ensure sterility. Healthcare providers should identify and quarantine affected inventory.

    Product
    PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-7039-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-2464-2023·2023-09-06

    Oncology Software Allergy Warnings May Not Display for Medication Ingredients

    RayCare oncology software versions 5A, 5B, and 6A may fail to display medication allergy warnings under certain circumstances. Healthcare facilities could inadvertently prescribe medications patients are allergic to.

    Product
    RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. Model Numbers: 5.0.0, 5.0.1, 5.1.1,5.1.2,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2475-2023·2023-09-06

    LIF AMP Adjustable Awl Recalled for Assembly Defect Preventing Depth Control

    Alphatec Spine is recalling the LIF AMP Adjustable Awl due to an assembly defect preventing the locking feature from engaging. This prevents proper depth control during surgery and risks dural tears, vascular injury, and neurologic damage.

    Product
    LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2469-2023·2023-09-06

    GS70 Salus Surgical Table may continue moving after control button release

    The GS70 Salus Surgical Table may continue moving after the control button is released if communication between the control pendant and table is interrupted. This affects 110 units distributed across the US and Australia/New Zealand.

    Product
    GS70 Salus Surgical Table, Product Code 18-070-70
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1127-2023·2023-09-06

    FDA Recalls Phenylephrine IV Bags Due to Unvalidated Sanitization

    Central Admixture Pharmacy Services is recalling 292 bags of phenylephrine IV solution due to unvalidated sanitization cycles that cannot assure product sterility. No illnesses have been reported.

    Product
    PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1268-2023·2023-09-06

    Siemens Atellica CH Analyzer: Reagent Carryover Affecting Magnesium Test Results

    Siemens Healthcare Diagnostics has recalled the Atellica CH LDL Cholesterol Direct diagnostic device due to reagent carryover affecting magnesium test accuracy. Approximately 8420 units distributed nationwide and internationally are affected.

    Product
    Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097632
    Category
    Medical Device
    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 (Drugs)·D-1112-2023·2023-09-06

    Cardioplegia Solution Recalled for Lack of Sterility Validation

    Central Admixture Pharmacy Services is recalling 786 bags of Cardioplegia Solution del Nido Formula nationwide due to lack of validation data for sanitization cycles, which affects sterility assurance.

    Product
    Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Rx Only, Central Admixture Pharmac
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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