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.

17276–17300 of 88183

  • HighFDA (Drugs)·D-1020-2023·2023-08-09

    Cardioplegia Solution Nationwide Recall Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling a cardioplegia solution nationwide due to lack of sterility assurance and insufficient validation data for sterilization decontamination cycles.

    Product
    CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium/low tromethamine, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0009-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2262-2023·2023-08-09

    Bronchoscopy Instruments Recalled for Electromagnetic Sensor Tracking Malfunction

    Olympus Corporation is recalling Always-On Tip Tracked Instruments due to a malfunction in the electromagnetic sensor that impairs navigation functionality during bronchoscopic procedures. The malfunction could result in procedural delays.

    Product
    Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing Model: INS-0352
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2283-2023·2023-08-09

    X-ray Imaging System Carriage Bolts May Loosen or Break

    Philips Allura Xper FD10 and FD20 X-ray systems may have loose or broken bolts supporting the FlexMove Carriage and cracks in the suspension rail. Affected units distributed worldwide; users should inspect equipment and contact manufacturer.

    Product
    Allura Xper FD10 and FD20. X-ray Imaging System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2277-2023·2023-08-09

    OEC 9900 Systems Image Intensifier Detachment and Fall Risk

    GE OEC 9900 fluoroscopy systems' image intensifiers can detach during movement if subjected to large impact force, potentially falling and causing injuries such as fractures or bruising.

    Product
    OEC 9900 Systems with 9-inch Image Intensifier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2023·2023-08-09

    Medline procedural kits with ultrasound gel may not meet sterility specifications

    Medline Industries recalls 146,157 custom procedural kits distributed April 2020 to April 2023 because the sterile ultrasound gel component may not meet sterility specifications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FISTULA, Model Number: DYNJ65711; b. ACCESS CATHETER, Model Number: DYNJ64141A; c. ACCESS PICC PACK, Model Number: DYNJ40682B; d. ADULT EPIV INSERTION…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1353-2023·2023-08-09

    WMU Premium Dough Recalled for Undeclared Soy Allergen

    Cassanos Inc is recalling WMU Premium Dough on Parchment for undeclared soy flour allergen. Affected products were distributed to Colorado, Florida, Indiana, Illinois, Kentucky, Michigan, Ohio, Pennsylvania, and West Virginia.

    Product
    WMU Premium Dough on Parchment: packaged as 14in
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1359-2023·2023-08-09

    Mondelez Recalls belVita Breakfast Sandwich Due to Undeclared Peanut Allergen

    Mondelez Global LLC is recalling belVita Breakfast Sandwich products because they may contain undeclared peanut allergen due to cross contamination. The recall affects approximately 445,264 cases distributed nationwide.

    Product
    belVita Breakfast Sandwich, Dark Chocolate Creme variety (6 - 8.8 oz. cartons)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-1061-2023·2023-08-09

    Fentanyl Injectable Solution Recalled for Sterility Validation Failure

    Central Admixture recalls 8,146 bags of fentanyl injection due to lack of sterilization cycle validation. This Class II recall affects patients nationwide who may receive contaminated IV medication.

    Product
    fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1329-2023·2023-08-09

    Blueberry bags recalled for undeclared tree nuts, peanuts, and wheat

    Houston Pecan Company recalls 5-pound bags of blueberries due to potential undeclared tree nuts, peanuts, and wheat from allergen cross-contamination. Affected packages were distributed in Texas and sold online prior to May 25, 2023.

    Product
    Blueberries, Blueberries, Cane Sugar, Sunflower Oil packaged in 5 pound bags
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1357-2023·2023-08-09

    Antonio's Rustico Pizza Dough recalled for undeclared soy flour

    Cassanos Inc is recalling Antonio's Rustico Pizza Dough (15in) distributed across nine states due to undeclared soy flour. Consumers with soy allergies are at risk.

    Product
    Antonio's Rustico Pizza Dough: packaged as 15in
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2293-2023·2023-08-09

    Medline Procedural Kits Recalled Due to Potential Sterility Failure

    Medline has recalled approximately 29,277 procedural kits containing ultrasound gel because the gel component may not meet sterility specifications. The recall covers kits distributed worldwide from April 2020 to April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a.18G CPNB 20G STYLETED CATHETER, Model Number: DYNJRA1869; b. ACUTE PAIN BLOCK TRAY, Model Number: DYNJRA0949C; c. ANESTHESIA BLOCK KIT, Model Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0965-2023·2023-08-09

    PHENYLephrine Injectable Syringe Recall Due to Insufficient Sterility Assurance

    Central Admixture Pharmacy Services recalls 499,304 PHENYLephrine syringes nationwide because validation data for sterility decontamination cycles was lacking. No illnesses have been reported.

    Product
    PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1011-2023·2023-08-09

    Neonatal TPN Starter Bag Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 420 neonatal TPN starter bags due to lack of sterility assurance and validation data for decontamination cycles. The recalled lots were 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 (Devices)·Z-2292-2023·2023-08-09

    Medline procedural kits may contain non-sterile ultrasound gel

    Medline is recalling 4,900 sterile procedural kits used for arterial line insertion because the ultrasound gel component may not meet sterility specifications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ART LINE KIT ICH OR, Model Number: ART900; b. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570; c. ARTERIAL BUNDLE NO CATHETER, Model Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1311-2023·2023-08-09

    Mandarin Noodle Salad Recalled for Undeclared Wheat Allergen

    Eat Good LLC is recalling Mandarin Noodle Salad due to undeclared wheat allergen. The product label declares pasta but does not identify wheat as an ingredient, posing a risk to consumers with wheat allergies.

    Product
    Mandarin Noodle Salad is a food service refrigerated product, packaged in 5lb flexible plastic packages, 2/5lb. packages are packed in cardboard cases. The salads are removed from the package and sold by the pound from deli display cases at the grocery stores. Mandarin…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-1075-2023·2023-08-09

    FDA Recalls Midazolam Injectable for Unvalidated Sterilization Process

    Central Admixture Pharmacy Services Inc is recalling 621 syringes of midazolam injection because the manufacturer lacked validation data to confirm the sterilization process was effective.

    Product
    midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-4036-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1323-2023·2023-08-09

    Mixed Nuts Recalled for Undeclared Tree Nuts, Peanuts, and Wheat

    Houston Pecan Company recalls mixed nuts due to potential undeclared tree nuts, peanuts, and wheat from allergen cross-contamination. Five-pound bags purchased before May 25, 2023, distributed in Texas and online are affected.

    Product
    Mixed Nuts Rst & Salted Pecans, Almonds, Cashews, Macadamia Nuts & Hazelnuts packaged in 5 pound bags
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2265-2023·2023-08-09

    Olympus SPiN Drive Histology Needle Recalled for Navigation Sensor Malfunction

    Olympus recalls SPiN Drive histology needles due to electromagnetic sensor tracking malfunction that impairs navigation functionality during endobronchial procedures, potentially causing procedural delays.

    Product
    Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1067-2023·2023-08-09

    Fentanyl-bupivacaine injection syringes recalled due to sterility assurance issue

    Central Admixture Pharmacy Services is recalling 1,486 syringes of fentanyl-bupivacaine injection nationwide due to lack of validated sanitization processes that may affect product sterility.

    Product
    fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2080-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0952-2023·2023-08-09

    Glycopyrrolate Injectable for Anesthesia Recalled Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 770 syringes of glycopyrrolate injectable medication nationwide due to lack of validation data for sterilization processes. The product may not meet required sterility standards for safe anesthesia use.

    Product
    glycopyrrolate 1 mg/5 mL (0.2 mg/mL), For Anesthesia Use, Syringe, RX ONLY, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6084-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0991-2023·2023-08-09

    Neonatal TPN IV bags recalled due to sterility validation deficiency

    Central Admixture Pharmacy Services is recalling 24 neonatal TPN IV bags due to lack of sterility assurance. Validation data for decontamination cycles is lacking, preventing confirmation that units are sterile.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/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: 72196-0425-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1351-2023·2023-08-09

    Beer Head Sheeted Pizza Dough Recalled for Undeclared Soy Flour

    Cassanos Inc is recalling Beer Head Sheeted Pizza Dough because soy flour is not declared on the label. Consumers with soy allergies may be at risk.

    Product
    Beer Head Sheeted Pizza Dough: packaged as 10in
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-1005-2023·2023-08-09

    Neonatal TPN IV Bags Recalled Over Sterility Assurance Failures

    Central Admixture Pharmacy Services is recalling 304 neonatal TPN IV starter bags nationwide due to lack of sterility assurance and insufficient validation of decontamination processes. No illnesses have been reported.

    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-2253-2023·2023-08-09

    Fusion Lithotripsy Extraction Basket Recalled for Mechanical Failure

    Wilson-Cook Medical is recalling Fusion Lithotripsy Extraction Baskets due to mechanical failures that may prevent proper basket advancement or retraction during biliary stone removal procedures.

    Product
    Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0995-2023·2023-08-09

    Neonatal TPN Starter Bags Recalled Due to Sterility Validation Deficiency

    Central Admixture Pharmacy Services is recalling 80 bags of Neonatal TPN Starter Bag nationwide due to insufficient sterility assurance. The deficiency stems from lacking validation data for decontamination cycles.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 2.5%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0402-1
    Category
    Drug
    Distribution
    Distributed nationwide