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.

22026–22050 of 88183

  • HighFDA (Devices)·Z-0097-2023·2022-10-26

    Medical Device Recall: Roche cobas 5800 False Results Due to Baseline Anomalies

    Roche Molecular Systems recalls the cobas 5800 PCR testing instrument due to false positive and invalid results caused by anomalous baselines. This may lead to erroneous or delayed diagnoses.

    Product
    cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0091-2023·2022-10-26

    IV Extension Sets Recalled for Bonded Joint Failure and Leakage Risk

    B. Braun extension sets (Product Code 470169) are recalled due to high probability of bonded joint failure, which may cause leakage or detachment during use, risking bloodstream infections and medication exposure.

    Product
    Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0053-2023·2022-10-26

    Lyons Ready Care Thickened Orange Nectar Recalled for Spoilage

    Lyons Magnus LLC is recalling Lyons Ready Care Thickened Orange Nectar due to indication of product spoilage. The recall affects 1,272 cases distributed nationwide with specific lot numbers and best-by dates in March 2023.

    Product
    Lyons Ready Care Thickened Orange Nectar packaged in combi-bloc multi wall paper cartons 46 fl oz cartons - 6 cartons to a case
    Category
    Food
    Distribution
    48 states
  • HighFDA (Food)·F-0064-2023·2022-10-26

    Nestle Cookie Dough Recalled for Plastic Contamination

    Nestle-USA is recalling Stuffed Chocolate Chip Cookie Dough due to consumer complaints of white plastic pieces found in the product. Consumers should not eat the product.

    Product
    "***Nestle***STUFFED***CHOCOLATE CHIP COOKIE DOUGH***4 JUMBO COOKIES***NET WT 8 OZ***"
    Category
    Food
    Distribution
    40 states
  • HighFDA (Food)·F-0057-2023·2022-10-26

    Lyons Ready Care Thickened Sweet Tea Recalled for Product Spoilage

    Lyons Magnus LLC is recalling Lyons Ready Care Thickened Sweet Tea with Lemon Nectar due to indication of product spoilage. Approximately 491 cases were distributed across all U.S. states.

    Product
    Lyons Ready Care Thickened Sweet Tea with Lemon Nectar packaged in combi-bloc multi wall paper cartons 46 fl oz cartons - 6 cartons to a case
    Category
    Food
    Distribution
    48 states
  • HighFDA (Food)·F-0069-2023·2022-10-26

    Tastykake Glazed Cherry Pie Recalled Due to Undeclared Soy Lecithin

    Flowers Foods is recalling Tastykake Glazed Cherry Pie due to undeclared soy lecithin in the product. The recalled product may pose a health risk to consumers with soy allergies.

    Product
    TASTYKAKE GLAZED CHERRY PIE NET WT 4.5 OZ (128g) UPC 0 25600 00969 7 DISTRIBUTED BY TASTY BAKING COMPANY, PHILADELPHIA, PA 19112
    Category
    Food
    Distribution
    50 states
  • HighFDA (Devices)·Z-0098-2023·2022-10-26

    Synthes Orthopedic Implant Drill Kit Recall: Incorrect Drill Guide Size

    Synthes (USA) Products LLC is recalling 81 SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kits nationwide due to incorrect drill guide sizing. The defect could result in bone damage and incorrectly placed drill holes during orthopedic surgery.

    Product
    SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and reconstructive surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0039-2023·2022-10-26

    Turner's Whole Milk Cottage Cheese Recalled for Bacterial Spoilage

    Titusville Dairy Products Co. is recalling Turner's Whole Milk Cottage Cheese (5.3oz) due to bacterial spoilage. Approximately 4,270 units were distributed to Pennsylvania.

    Product
    Turner's Whole Milk Cottage Cheese 5.3oz. (150g) UPC:3573300166
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0040-2023·2022-10-26

    Turner's Peach Cottage Cheese Recalled for Bacterial Spoilage

    Titusville Dairy Products Co. is recalling Turner's Peach Whole Milk Cottage Cheese (5.3oz) distributed in Pennsylvania due to bacterial spoilage. Consumers should not consume the product and should discard it.

    Product
    Turner's Peach Whole Milk Cottage Cheese 5.3oz. (150g) UPC:3573300167
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0065-2023·2022-10-26

    Mrs. Freshley's Apple Fruit Pie recalled for undeclared soy allergen

    Flowers Foods is recalling Mrs. Freshley's Apple Fruit Pie (4.5 oz) because some packages may contain undeclared soy lecithin, a major allergen. Consumers with soy allergies should not consume the affected product.

    Product
    Mrs. Freshley's Apple Fruit Pie NET WT 4.5 OZ (128g) UPC 0 72250 00817 4 DISTRIBUTED BY FLOWERS FOODS SPECIALTY GROUP, LLC, 5987 SOUTH ROYAL ATLANTA DR, TUCKER, GA 30084
    Category
    Food
    Distribution
    50 states
  • HighFDA (Food)·F-0071-2023·2022-10-26

    Rocky Road Trail Mix recalled for glass contamination

    Diamond Foods' Rocky Road Trail Mix (20 oz bags) is being recalled due to glass pieces found in the product. Consumers should stop using affected batches immediately.

    Product
    Rocky Road Trail Mix, 20 oz UPC: 021130 162550 Store in refrigeration for freshness. Distributed by Better Living Brands, LLC, OP Box 99, Pleasanton, CA 94566
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0089-2023·2022-10-26

    Dimension Vista HDLC Reagent Cartridge Recalled for Inaccurate Lab Results

    Siemens is recalling 1,592 units of Dimension Vista HDLC reagent cartridges due to potential for erroneous test results. Affected cartridges may produce falsely high or low HDL cholesterol measurements.

    Product
    Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0067-2023·2022-10-26

    Tastykake Glazed Apple Pie Recalled for Undeclared Soy Allergen

    Flowers Foods is recalling Tastykake Glazed Apple Pie because soy lecithin is not declared on the labels. People with soy allergies could be at risk.

    Product
    TASTYKAKE GLAZED APPLE PIE NET WT 4.5 OZ (128g) UPC 0 25600 00972 7 DISTRIBUTED BY TASTY BAKING COMPANY, PHILADELPHIA, PA 19112
    Category
    Food
    Distribution
    50 states
  • HighFDA (Devices)·Z-0107-2023·2022-10-26

    Medicina ENFit enteral syringe recall due to material specification defect

    Medicina is recalling ENFit 1ml enteral syringes because the plunger was manufactured with polyethylene instead of approved polypropylene. This material defect could affect plunger function and device safety.

    Product
    Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0114-2023·2022-10-26

    Medicina Reusable Oral Syringe recalled for incorrect plunger material

    Medicina Uk Ltd is recalling Medicina Reusable Oral Syringe 2.5ml units because plunger components were manufactured with polyethylene instead of the specified polypropylene material.

    Product
    Medicina Reusable Oral syringe 2.5ml Code: OTH25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0111-2023·2022-10-26

    Medicina Oral Tip Syringe recalled for unapproved plunger material

    Medicina Uk Ltd is recalling Medicina Oral Tip Syringe 2.5ml nationwide because the plunger component was manufactured with polyethylene instead of the approved polypropylene material.

    Product
    Medicina Oral Tip Syringe 2.5ml Code: OT25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0070-2023·2022-10-26

    Tastykake Glazed Lemon Pie Recalled for Undeclared Soy

    Flowers Foods recalled Tastykake Glazed Lemon Pies due to undeclared soy lecithin in certain packages. Products with Enjoy By dates of Oct. 28, 31, Nov. 4, and 7 are affected.

    Product
    TASTYKAKE GLAZED LEMON FLAVORED PIE NET WT 4.5 OZ (128g) UPC 0 25600 00967 3 DISTRIBUTED BY TASTY BAKING COMPANY, PHILADELPHIA, PA 19112
    Category
    Food
    Distribution
    50 states
  • HighFDA (Devices)·Z-0117-2023·2022-10-26

    MitraClip G4 and TriClip G4 Cardiac Devices Recalled for Clip Locking Malfunction

    Abbott has recalled MitraClip G4 and TriClip G4 cardiac repair devices due to clip locking malfunctions that may prevent proper device deployment. These malfunctions could lead to failed procedures and serious complications including device embolization.

    Product
    Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW, MitraClip G4 CDS XT REPAIR-MR Clinical/CDS0704-XT, MitraClip G4 CDS XTW REPAIR-MR Clinical/CDS0704-XTW, TriClip NT Clip Delivery Sys CLIN/TCDS0203-NT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0041-2023·2022-10-26

    Turner's Pineapple Cottage Cheese Recalled for Bacterial Spoilage

    Turner's Pineapple Whole Milk Cottage Cheese 5.3oz is being recalled due to potential bacterial spoilage. The product was distributed in Pennsylvania; affected consumers should discard it.

    Product
    Turner's Pineapple Whole Milk Cottage Cheese 5.3oz. (150g) UPC:3573300168
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0056-2023·2022-10-26

    Lyons Ready Care Thickened Cranberry Honey Nectar Recalled for Product Spoilage

    Lyons Magnus LLC is recalling Lyons Ready Care Thickened Cranberry Honey Nectar due to indication of product spoilage. The recall involves 468 cases distributed across 49 states.

    Product
    Lyons Ready Care Thickened Cranberry Honey Nectar packaged in combi-bloc multi wall paper cartons 46 fl oz cartons - 6 cartons to a case
    Category
    Food
    Distribution
    48 states
  • ModerateFDA (Food)·F-0042-2023·2022-10-26

    Turner's Cottage Cheese Recalled for Bacterial Spoilage

    Titusville Dairy Products Co. is recalling Turner's Apple Cinnamon Whole Milk Cottage Cheese (5.3oz) due to bacterial spoilage. The affected products were distributed to a direct consignee in Pennsylvania.

    Product
    Turner's Apple Cinnamon Whole Milk Cottage Cheese 5.3oz. (150g) UPC:3573300169
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0059-2023·2022-10-26

    Imperial Thickened Orange Nectar Recalled for Product Spoilage

    Lyons Magnus LLC is recalling Imperial Thickened Orange Nectar due to indication of product spoilage. The 46 fl oz cartons were distributed nationwide.

    Product
    Imperial Thickened Orange Nectar packaged in combi-bloc multi wall paper cartons 46 fl oz cartons - 6 cartons to a case
    Category
    Food
    Distribution
    48 states
  • ModerateFDA (Food)·F-0052-2023·2022-10-26

    Lyons Ready Care Thickened Apple Nectar Recalled for Product Spoilage

    Lyons Magnus LLC recalls Lyons Ready Care Thickened Apple Nectar in 46 fl oz cartons due to product spoilage. Affected products were distributed nationwide.

    Product
    Lyons Ready Care Thickened Apple Nectar packaged in combi-bloc multi wall paper cartons 46 fl oz cartons - 6 cartons to a case
    Category
    Food
    Distribution
    48 states
  • ModerateFDA (Devices)·Z-0103-2023·2022-10-26

    Optima Coil System Pouch Labels Do Not Match Carton Labels

    BALT USA is recalling Optima Coil System models OPTI0208CSS10 and OPTI0308CSS10 due to a labeling discrepancy where pouch labels do not match carton labels. These endovascular devices require verification before use.

    Product
    Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0014-2023·2022-10-26

    OTC Sinus Pressure and Pain Cough Product Mislabeled as Decongestant-Free

    Walgreens Sinus Pressure, Pain & Cough tablets are mislabeled as 'Decongestant Free' but contain Phenylephrine HCl, a nasal decongestant. The labeling error affects 66,384 boxes distributed nationwide.

    Product
    SINUS PRESSURE, PAIN AND COUGH — SINUS PRESSURE, PAIN AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide