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.

9576–9600 of 27206

  • ModerateFDA (Devices)·Z-3112-2024·2024-09-18

    Medline Suction Liners Recalled Due to Potential Loss of Suction

    Medline is recalling 1,616 units of semi-rigid suction liners (ENDO KIT, pack numbers DYKE1350D and DYKE1514B) manufactured September to November 2023 that may lose or provide reduced suction during use.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; b) ENDO KIT, Pack Number DYKE1514B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3098-2024·2024-09-18

    Vital Signs Monitor Recalled Due to Inadequate Battery Warning Labels

    Zoe Medical is recalling 6,429 Spacelabs Ultraview DM3 Vital Signs Monitors because labeling does not adequately warn users about risks from damaged or expired batteries.

    Product
    Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3103-2024·2024-09-18

    Diagnostic test shows measurement bias at critical threshold

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur CA 19-9 test kits due to positive bias in measurements around the critical threshold of 35 U/mL, affecting diagnostic accuracy.

    Product
    ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491379 SMN: 11206239
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1804-2024·2024-09-18

    Amazon Fresh Macaroni Salad recalled for foreign material contamination

    Reser's Fine Foods is recalling Amazon Fresh Fresh Classic Macaroni Salad due to foreign material contamination. The product was distributed in nine states with a use-by date of September 13, 2024.

    Product
    UPC 95515 04502, Amazon Fresh Fresh Classic Macaroni Salad 16oz, refrigerated, packaged in a clear plastic tub with printed labels on top, bottom and side. There are 12 tubs per case.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-3094-2024·2024-09-18

    Reprocessed Surgical Sealer/Divider Recalled for Potential Packaging Seal Defect

    Medline Industries is recalling the ReNewal Reprocessed Covidien LigaSure Impact Sealer/Divider due to a potential incomplete seal on the packaging tray. The recall affects 230 units nationwide.

    Product
    Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF4418CR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2943-2024·2024-09-11

    Trilogy Evo Ventilator Software Update for Identified Safety Issues

    Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for the Trilogy Evo Universal Ventilator to address safety issues identified in earlier recalls. Affected units should implement the update.

    Product
    Trilogy Evo Universal Ventilator, Model No. DS2000X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1762-2024·2024-09-11

    JFE Pico de Gallo Classic Products Recalled for Listeria Contamination

    JFE FRANCHISING INC is recalling Pico de Gallo Classic products in Kentucky, Michigan, Ohio, and West Virginia due to potential Listeria monocytogenes contamination. Consumers should not consume affected products and should return them to the place of purchase or discard them.

    Product
    Pico de Gallo Classic Hot - 14 oz 639123880116 Pico de Gallo Classic Medium - 14 oz 639123880093 Pico de Gallo Classic Mild - 14 oz 639123880109 Plastic Clam-Shell Container
    Category
    Food
    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-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-2942-2024·2024-09-11

    Trilogy Evo EV300 Ventilator Mandatory Software Update for Safety Issues

    Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for Trilogy Evo EV300 ventilators to resolve previously identified safety issues. Approximately 90,910 US units and 56,273 international units are affected.

    Product
    Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Food)·F-1761-2024·2024-09-11

    JFE Franchising salsa medium and mild recalled for Listeria monocytogenes

    JFE Franchising is recalling medium and mild salsa products sold in Kentucky, Michigan, Ohio, and West Virginia due to potential Listeria monocytogenes contamination.

    Product
    Salsa Medium - 16 oz Salsa Mild - 16 oz Plastic Clam-Shell Container
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2690-2024·2024-09-11

    Vivo 45 LS Ventilator Recall: Potential Formaldehyde Emission Risk

    Breas Medical is recalling the Vivo 45 LS ventilator due to potential elevated formaldehyde emissions into the patient breathing airpath under specific conditions.

    Product
    Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1794-2024·2024-09-11

    Terrafina Golden Raisins Recalled Due to Undeclared Sulfites

    Terrafina Golden Raisins (10oz) are being recalled due to undeclared sulfites. This FDA Class I recall affects products distributed to retailers in New York.

    Product
    Terrafina Golden Raisins Net Wt. 10oz (283g) UPC:847938001385. Packaged in a plastic container, 8 containers per case.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0649-2024·2024-09-11

    FDA Recalls Heparin Sodium Injection for Endotoxin Contamination

    Baxter Healthcare Corporation is recalling 44,208 containers of Heparin Sodium in Sodium Chloride Injection nationwide after endotoxin testing revealed out-of-limit results. The contamination poses a risk of serious adverse reactions in patients receiving the intravenous medication.

    Product
    HEPARIN SODIUM IN SODIUM CHLORIDE — HEPARIN SODIUM IN SODIUM CHLORIDE (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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, US
    Category
    Medical Device
    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 (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-1760-2024·2024-09-11

    Chopped Cilantro with White Onion Recalled for Listeria

    JFE Franchising Inc recalls 5oz packages of chopped cilantro with white onion due to potential Listeria monocytogenes contamination. Affected products were distributed in Kentucky, Michigan, Ohio, and West Virginia.

    Product
    Chopped Cilantro with White Onion - 5oz Plastic Clam-Shell Container
    Category
    Food
    Distribution
    4 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-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-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-1787-2024·2024-09-11

    Apple Danish Recalled for Incorrect Almond Croissant Ingredient Labeling

    SSP America PHX is recalling Apple Danish products due to incorrect ingredient labeling. The label lists Almond Croissant ingredients instead of Apple Danish, creating a risk for consumers with tree nut allergies.

    Product
    Apple Danish in a clear plastic bag with a white paper label attached to the top of the plastic bag.
    Category
    Food
    Distribution
    1 state