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.

15176–15200 of 27263

  • HighFDA (Devices)·Z-2481-2023·2023-09-06

    Surgical Rasp Handle May Fracture Due to Weld Crack

    The Link OptiStem Rasp Handle used in knee replacement surgery may develop a crack in the weld that causes the handle to fracture. If this occurs, surgical removal of the rasp must be modified, potentially prolonging the procedure.

    Product
    Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2484-2023·2023-09-06

    Oculus Myopia Master optical device recalled for insufficient anti-reflective coating

    Oculus Optikgeraete GMBH is recalling 173 units of the Oculus Myopia Master optical measurement device due to insufficient anti-reflective coating that may cause incorrect axial length measurements.

    Product
    Oculus Myopia Master , Ref 68100, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2489-2023·2023-09-06

    Upper roller bracket for Radixact gantry enclosure may lack adequate service clearance

    Accuray is recalling upper roller brackets for the Radixact Treatment Delivery System because they may not provide sufficient clearance for service personnel to safely use equipment during maintenance, creating a possible injury risk.

    Product
    Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1463-2023·2023-09-06

    Del Monte Canned Fruit Recall Due to Improper Temperature Storage

    C & S Wholesale Grocers is recalling approximately 29,469 cases of Del Monte canned fruit products sold at Stop & Shop stores in NY, NJ, and CT because they were not held at appropriate temperatures during distribution.

    Product
    The following items sold at Stop & Shop stores located in the New York Metro Region: Del Monte Red Grapefruit Del Monte Citrus Salad Del Monte Grapefruit No sugar added Del Monte Pears Del Monte Blueberry Parfait Del Monte Mandarine Orange Del Monte Peaches No Sugar Added Del M
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-1138-2023·2023-09-06

    dilTIAZem IV Bags Recalled Due to Lack of Sterilization Validation

    Central Admixture Pharmacy Services is recalling 703 bags of dilTIAZem 125mg IV medication due to lack of validated sterilization processes. Healthcare providers and patients should verify lot numbers.

    Product
    dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1
    Category
    Drug
    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-1108-2023·2023-09-06

    FDA Recalls Cardioplegia Solution Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 184 units of Cardioplegia Solution nationwide due to lack of validation data for sterilization cycles, which compromises sterility assurance in this injectable cardiac medication.

    Product
    CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1115-2023·2023-09-06

    Neonatal Intravenous Nutrition Bags Recalled for Insufficient Sterility Validation

    Central Admixture Pharmacy Services recalled 40 bags of Neonatal TPN starter bags due to lack of validation data for sanitization cycles. This creates a potential sterility assurance gap for an intravenous medication used for newborns.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3% / Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0404-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1461-2023·2023-09-06

    Multiple Juice and Beverage Products Recalled for Improper Temperature Storage

    C & S Wholesale Grocers Inc. is recalling 29,469 cases of various beverages sold at Stop & Shop stores in the New York Metro Region due to improper temperature storage that may have compromised product safety.

    Product
    The following items sold at Stop & Shop stores located in the New York Metro Region: Natures Promise Lemonade Natures Promise Orange Natures Promise Tangerine Harmless Harvest Coconut Water Organic Natalies Guava Lemonade Natalies Lemonade Natalies Guava Lemonade Natalies Strawb
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-1110-2023·2023-09-06

    Cardioplegia Solution Recalled for Unvalidated Sterilization Process

    Central Admixture Pharmacy Services is recalling a cardioplegia solution nationwide due to lack of validated sterilization processes used during its manufacture.

    Product
    CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-2472-2023·2023-09-06

    Siemens Atellica CH LDL Cholesterol analyzer reagent carryover issue

    Siemens is recalling Atellica CH analyzers due to potential reagent carryover that can cause falsely elevated results in cholesterol, bilirubin, and liver enzyme tests. This could affect the accuracy of patient laboratory results.

    Product
    Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin Test Code: LDLC Siemens Material Number (SMN): 11537214
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1472-2023·2023-09-06

    Moore Family Farms Cheddar Cheese Curds Recalled for Coliform and E. Coli Contamination

    Moore Family Farms and Creamery Cheddar Cheese Curds (1 lb plastic bags) are being recalled due to potential contamination with elevated coliform counts and E. coli. The recall affects 30 bags distributed in Iowa.

    Product
    Moore Family Farms and Creamery Cheddar Cheese Curds, 1 lb plastic bag.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1118-2023·2023-09-06

    Neonatal TPN Starter Bags Recalled for Sterility Assurance Gaps

    Central Admixture Pharmacy Services is recalling 140 bags of Neonatal TPN Starter Bag due to lack of validation data for sanitization cycles. The injectable nutrition product was distributed nationwide.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0420-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1109-2023·2023-09-06

    Cardioplegia Solution Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 84 bags of Cardioplegia Solution (Lot #36-262515) due to lack of validation data for sanitization cycles, creating uncertainty about sterility standards for this injectable product.

    Product
    CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1466-2023·2023-09-06

    Gourmet Garden Herbs Recalled for Improper Temperature Storage

    C & S Wholesale Grocers is recalling 29,469 cases of Gourmet Garden herb and spice products sold at Stop & Shop stores in the New York Metro region due to improper temperature storage. Consumers should discard these products.

    Product
    The following items sold at Stop & Shop stores located in the New York Metro Region: Gourmet Garden Jalapeno Groumet Garden Roasted Garlic Gourmet Garden Italian Herb Gourmet Garden Parsley Blend Gourmet Garden Cilantro Gourmet Garden Ginger Gourmet Garden Chunky Garlic Gourmet
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1142-2023·2023-09-06

    Sabril (vigabatrin) oral solution recalled for cross-contamination

    Lundbeck LLC recalls Sabril (vigabatrin) oral solution nationwide due to potential cross-contamination. The recall affects 10,543 cartons.

    Product
    SABRIL — SABRIL (VIGABATRIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1486-2023·2023-09-06

    Grape Juice Recalled for Bloating in Sealed Cups

    Lyons Magnus LLC is recalling GFS Harvest Valley Grape Juice in 4 fl oz cups due to signs of bloating in containers. Consumers in multiple states should not consume and should dispose of the product safely.

    Product
    GFS Harvest Valley Grape Juice packaged in 4 fl oz opaque white plastic cup 96 cups per case
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1269-2023·2023-09-06

    Siemens Atellica CH Total Protein II Recalled for Reagent Carryover

    Siemens Healthcare Diagnostics is recalling Atellica CH Total Protein II due to reagent carryover affecting magnesium test accuracy. The recall covers all lots (13,071 units) distributed nationwide and internationally.

    Product
    Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097604
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1139-2023·2023-09-06

    Clindamycin Phosphate Topical Solution Recalled for Defective Container

    Contract Pharmaceuticals is recalling Clindamycin Phosphate Topical Solution USP 1% due to defective containers that leak under the cap. The recall affects 11,350 bottles distributed nationwide.

    Product
    Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufactured by: Contract Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, NDC# 71428-003-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1450-2023·2023-08-30

    Freshy Foods Recalls Team Fresh & Go Cantaloupe Cups for Listeria Risk

    Freshy Foods is recalling Team Fresh & Go Cantaloupe Cups due to potential Listeria monocytogenes contamination. The affected product was distributed in Florida, Louisiana, and Mississippi.

    Product
    Team Fresh & Go: Cantaloupe Cup, packaged in 12oz plastic cup with lid. Packaged and sold as single unit.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1477-2023·2023-08-30

    Soft Serve on the Go Vanilla Chocolate Ice Cream Recalled for Listeria

    Real Kosher Ice Cream, Inc. is recalling Soft Serve on the Go brand Vanilla Chocolate ice cream due to potential Listeria monocytogenes contamination. The product was distributed across multiple U.S. states and several countries.

    Product
    Soft Serve on the Go brand Vanilla Chocolate flavor; 8 fl oz; UPC 0-91404-15129-0 Soft Serve on the Go brand Parve Vanilla Chocolate flavor; 8 fl oz; UPC 0-91404-15113-9
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-1481-2023·2023-08-30

    Soft Zero on the Go Lite Peanut Butter Ice Cream Recalled for Listeria

    Soft Zero on the Go brand Lite Peanut Butter ice cream is being recalled due to potential Listeria monocytogenes contamination. The affected product was distributed across multiple U.S. states and internationally.

    Product
    Soft Zero on the Go brand Lite Peanut Butter flavor; 8 fl oz; UPC 0-91404-15285-3
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-1478-2023·2023-08-30

    Soft Serve on the Go Peanut Butter ice cream recalled for Listeria contamination

    Real Kosher Ice Cream recalls Soft Serve on the Go Peanut Butter ice cream due to potential Listeria contamination. Consumers should discard the product or return it.

    Product
    Soft Serve on the Go brand Razzle n' Dazzle Peanut Butter flavor; 8 fl oz; UPC 0-91404-15133-7
    Category
    Food
    Distribution
    20 states