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.

11351–11375 of 88183

  • SevereFDA (Food)·F-1763-2024·2024-09-11

    Diced Pepper and Fajita Mix Products Recalled for Listeria Contamination

    JFE FRANCHISING INC is recalling diced pepper and fajita mix products sold in Kentucky, Michigan, Ohio, and West Virginia due to potential Listeria monocytogenes contamination. Consumers should discard the products or return them to the store.

    Product
    Diced Pepper Tri-Blend - 8 oz 639123880024 Diced Pepper w/ White Onion - 7 oz 639123880048 Fajita Mix, Hot $5.00 - 11 oz 639123880406 Fajita Mix, Mild $5.00 - 11 oz 639123880390 Diced Jalapeno - 7oz 639123880031 Plastic Clam-Shell Container
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2721-2024·2024-09-11

    Fresenius Kabi IV Administration Sets Recalled for Uncontrolled Medication Flow Risk

    Fresenius Kabi is recalling LVP Primary Administration Sets due to a defect that may cause uncontrolled medication flow and potential overdose. The recall affects 4,500 pieces distributed in Colorado, Idaho, New Jersey, and Utah.

    Product
    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Food)·F-1781-2024·2024-09-11

    Popsicle Jolly Rancher Frozen Pops Recalled for Undeclared Milk Allergen

    Unilever North America is recalling Popsicle Jolly Rancher Frozen Confection Pops nationwide due to undeclared milk, which poses a risk to consumers with milk allergies.

    Product
    Popsicle Jolly Rancher Frozen Confection Pop Net Wt 2.71 FL OZ (80 ML). Green Apple Blue Raspberry and Grape flavored. GTIN/UPC 10077567003727 Case UPC 77567003720
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1759-2024·2024-09-11

    Butternut Squash Cubes Recalled Due to Listeria Contamination Risk

    Butternut squash cubes sold in Kentucky, Michigan, Ohio, and West Virginia are recalled due to potential Listeria monocytogenes contamination. Affected products have sell-by dates between July 9 and July 26, 2024.

    Product
    Butternut Squash Cubes - 12oz Plastic Clam-Shell Container
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1764-2024·2024-09-11

    Guacamole products recalled due to Listeria monocytogenes contamination

    JFE Franchising is recalling guacamole products due to Listeria monocytogenes contamination. Affected items were distributed in Kentucky, Michigan, Ohio, and West Virginia with sell-by dates from July 9 to July 26, 2024.

    Product
    Guacamole & Pico de Gallo Combo $7.99 - 16 oz 639123880574 Guacamole Chunky Medium - 14 oz 639123880161 Guacamole Chunky Mild - 14 oz 639123880154 Guacamole Blender Mild $5.99 - 12 oz 639123880789 Plastic Clam-Shell Container
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2944-2024·2024-09-11

    Philips Respironics Trilogy Evo Ventilator Software Update Addresses Safety Issues

    Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for Trilogy Evo ventilators worldwide to resolve identified safety issues. Users must apply the update and review the updated User Manual.

    Product
    Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2, Germany DE2110X13B Trilogy Evo, Germany DS2100X11B Trilogy Evo, O2…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1779-2024·2024-09-11

    Ground Cinnamon Recalled Nationwide for Elevated Lead Levels

    MAMTAKIM Inc. is recalling ground cinnamon products distributed to nine states due to elevated lead content. The 15 g paper carton product carries code 10C035.

    Product
    Scortisoara macinata/ Ground cinnamon, 15 g, Paper cartons, 20 pieces per paper carton
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1774-2024·2024-09-11

    Reser's Creamy Deluxe Potatoes Recalled for Temperature Abuse Risk

    Reser's Fine Foods is recalling 182 cases of Potatoes Creamy Deluxe Special Request due to temperature abuse that may cause food spoilage.

    Product
    Item 71117.14446, Potatoes Creamy Deluxe Special Request, refrigerated product, net wt. 5lb. There are 4 packs per case.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1777-2024·2024-09-11

    Refrigerated Pasta Salad Recalled for Temperature Abuse and Spoilage Risk

    Reser's Fine Foods is recalling Stonemill Kitchens Green Goddess Pasta Salad due to potential spoilage from temperature abuse caused by a malfunctioning refrigeration unit. The product was distributed in CA, IL, MN, ND, and SD.

    Product
    Item 71117.18531, Stonemill Kitchens Green Goddess Pasta Salad, refrigerated product, net wt. 5lb. There are 2 packs per case.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2947-2024·2024-09-11

    BD Pyxis QFill Medication Cabinet Software Issue Causes Incorrect Bin Labeling

    A software bug in BD Pyxis QFill medication cabinet systems may print incorrect medication bin labels during restocking, potentially causing medication errors. Three units are affected.

    Product
    BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1546-2024·2024-09-11

    Beckman Coulter DxI 9000 Analyzer Recalled for Leaking Wash Buffer Tank

    Beckman Coulter is recalling 17 DxI 9000 Access Immunoassay Analyzers due to cracks in the Internal Wash Buffer Tank that can cause leaking, potentially delaying test results and exposing users to chemical and physical hazards.

    Product
    DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0653-2024·2024-09-11

    Compounded Semaglutide Recalled Due to Lack of Sterility Assurance

    ProRx LLC is recalling 1,960 vials of compounded semaglutide nationwide due to lack of assurance of sterility. The multiple-dose vials may not meet sterility standards for injectable medications.

    Product
    SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1783-2024·2024-09-11

    Pita Jungle Cilantro Jalapeno Hummus Snack Packs Recalled for Undeclared Sesame

    SSP America PHX, LLC recalls Pita Jungle Cilantro Jalapeno Hummus & Pita Chips snack packs due to undeclared sesame allergen on the label. Consumers with sesame allergy risk serious allergic reactions.

    Product
    Pita Jungle Cilantro Jalapeno Hummus & Pita Chips packaged as individual "snack pack" in 9.2oz plastic clamshell container.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2952-2024·2024-09-11

    Desflurane anesthesia vaporizer recalled for possible excessive anesthetic output

    Mindray's Desflurane E_Vap vaporizer may deliver anesthetic at higher concentrations than set due to an incomplete seal. Patients could inhale excessive anesthetic, potentially causing dizziness, drowsiness, and in severe cases, neurological effects.

    Product
    Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number115-066759-00
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2949-2024·2024-09-11

    Sevoflurane Vaporizer for A9 Anesthesia System Recalled for Output Malfunction

    Mindray recalled 2 Sevoflurane E_Vap vaporizers used in A9 Anesthesia Systems due to a component defect causing excessive anesthetic output. The defect risks patient anesthetic overdose with potential neurological effects including post-operative vertigo and drowsiness.

    Product
    Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number 115-066755-00
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Drugs)·D-0655-2024·2024-09-11

    Tirzepatide Injectable Vials Recalled for Sterility Assurance

    ProRx LLC is recalling Tirzepatide 20 mg/2mL injectable vials nationwide due to lack of assurance of sterility. Patients who received vials from lot ProRx051424 should contact their healthcare provider.

    Product
    TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0652-2024·2024-09-11

    Compounded Semaglutide Injection Vials Recalled for Sterility Concerns

    ProRx LLC is recalling approximately 8,396 vials of compounded semaglutide due to lack of assurance of sterility. The medication was distributed nationwide.

    Product
    SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0654-2024·2024-09-11

    ProRx Compounded Semaglutide/Cyanocobalamin Injection Recalled Due to Sterility Assurance Issues

    ProRx LLC is recalling 500 vials of compounded Semaglutide/Cyanocobalamin Injection (Lot #ProRx031924-1) distributed nationwide in the United States due to lack of sterility assurance. The beyond-use date is 09/18/2024.

    Product
    Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1766-2024·2024-09-11

    Reser's American Classics Scalloped Potatoes Recalled Due to Temperature Abuse

    Reser's Fine Foods is recalling Reser's American Classics Scalloped Potatoes because a refrigeration unit malfunction caused temperature abuse during shipment, potentially leading to spoilage. Consumers should not consume this product.

    Product
    Item 71117.02008, Reser's American Classics Scalloped Potatoes, refrigerated product, net wt. 12oz. There are 6 packs per case.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1780-2024·2024-09-11

    Ham and Cheese Croissants Recalled for Potential Listeria Contamination

    WR Coffee Inc recalled 90 Ham and Cheese Croissants distributed in Texas due to potential Listeria monocytogenes contamination.

    Product
    Ham and Cheese Croissant (approximately 6.5 oz) delivered fresh in bins to the firm's Restaurants- no label. Not individually packaged.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2966-2024·2024-09-11

    Impella 5.5 Pump Labeling Updated Due to Device Interaction

    Abiomed updated Impella 5.5 cardiac pump labeling to document a potential interaction with Shockwave Coronary IVL Catheter during coronary procedures. No injuries have been reported.

    Product
    Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0656-2024·2024-09-11

    Tirzepatide Injectable Drug Recalled for Sterility Assurance Defect

    ProRx LLC is recalling 1,732 vials of Tirzepatide 60 mg/3mL nationwide due to lack of assurance of sterility. Affected lots have beyond-use dates of 11/21/2024 and 12/09/2024.

    Product
    TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2950-2024·2024-09-11

    Anesthesia Vaporizer Adapter May Deliver Excessive Anesthetic Concentration

    Sevoflurane vaporizer adapters used with Mindray A9 anesthesia systems may deliver higher-than-set anesthetic concentrations due to incomplete sealing. Patients could inhale excessive anesthetic, potentially causing drowsiness, vertigo, or in severe cases, neurological effects.

    Product
    Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: 115-066756-00
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2978-2024·2024-09-11

    Medical Device Sample Holder Recalled for Adhesive Joint Failure

    Beckman Coulter Power Express sample holders can fail at the adhesive joint between plastic socket and metal component. This may cause the metal part to detach inside the centrifuge, potentially damaging equipment and exposing lab staff to biohazardous material.

    Product
    Power Express, REF B90918
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1784-2024·2024-09-11

    Pita Jungle Hummus & Pita Chips Recalled for Undeclared Sesame Allergen

    Pita Jungle Hummus & Pita Chips snack packs are being recalled because the product label fails to declare sesame, an ingredient in the hummus. Consumers with sesame allergies may face health risks.

    Product
    Pita Jungle Hummus & Pita Chips packaged as individual "snack pack" in 9.2oz clamshell plastic container.
    Category
    Food
    Distribution
    1 state