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.

17501–17525 of 88183

  • HighFDA (Devices)·Z-2215-2023·2023-08-02

    Respiratory diagnostic panel fails to produce test results

    Qiagen's QIAstat-Dx Respiratory SARS-CoV-2 Panel may fail to produce diagnostic results due to software errors in affected cartridges. Test runs will abort with error codes, leaving no test results available.

    Product
    QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human…
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2245-2023·2023-08-02

    Respiratory Diagnostic Test Kits Recalled for Decreased Performance Reliability

    Qiagen's QIAstat-Dx Respiratory SARS-CoV-2 Panel diagnostic kits are recalled due to decreased performance reliability. Failed test runs could require sample retesting, potentially delaying diagnosis.

    Product
    QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2243-2023·2023-08-02

    Ventral Hernia Mesh Balloon May Fail to Inflate During Surgery

    A surgical mesh implant used in ventral hernia repair may fail to inflate properly during the procedure, potentially causing inadequate placement and infection risk. The manufacturer is recalling 169 units worldwide.

    Product
    Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450G (EU…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0942-2023·2023-08-02

    Safe Tussin DM Cough Suppressant Recalled for Manufacturing Deviation

    Kramer Laboratories is recalling Safe Tussin DM Cough + Chest Congestion due to a manufacturing deviation involving non-food grade lubricant in the mixing vessel. Affected lots 8753, 8753A, and 8659 were distributed nationwide.

    Product
    Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2225-2023·2023-08-02

    Diagnostic Verification Product May Not Meet Shelf Life Stability Specifications

    Ortho-Clinical Diagnostics is recalling VITROS NT-proBNP II Range Verifiers Lot 0090 because the product may not meet shelf life stability specifications. Used for diagnostic system calibration verification.

    Product
    VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2226-2023·2023-08-02

    A901 Communication Manager Software Update Not Available for Intellis System

    The A901 Communication Manager application did not receive a timely update to match the A710 Clinician Programmer software release for Intellis Neurostimulation Systems, creating a version mismatch.

    Product
    A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1296-2023·2023-08-02

    Dietary supplement labeling deficiencies recall - Natural Systems HAIR SKIN NAIL

    Emceta International Inc. recalled Natural Systems HAIR - SKIN NAIL dietary supplement (576 bottles, lot 42049) for labeling deficiencies that fail to comply with FDA regulations.

    Product
    Natural Systems, HAIR - SKIN NAIL, Dietary Supplement 60 Capsules
    Category
    Other
    Distribution
    0 states
  • ModerateFDA (Food)·F-1295-2023·2023-08-02

    Natural Systems Multi Vitamin Recalled for Low Magnesium Content

    FDA analysis found Natural Systems Naturasys Multi Vitamin contains magnesium at only 33.5% of the labeled amount. The recall affects 554 bottles with lot 38883 (expires 07/2024).

    Product
    Natural Systems, Naturasys MULTI VITAMIN HIGH POTENCY AND FORMULATION, Dietary Supplement 60 Tablets
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-1294-2023·2023-08-02

    Trader Joe's Unexpected Broccoli Cheddar Soup recalled for insect contamination

    Winter Gardens Quality Foods is recalling Trader Joe's Unexpected Broccoli Cheddar Soup due to insects found in frozen broccoli florets. The recall affects 10,889 cases distributed to FL, IL, CA, TX, WA, PA, and CT.

    Product
    Trader Joes Unexpected Broccoli Cheddar Soup ( Sharp Cheddar Cheese & Unexpected Cheddar Cheese )Keep Refrigerated, NET WT. 20 OZ (1 LB 4 OZ ) 567g, 12 in a Case
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·F-1291-2023·2023-08-02

    Sprouts Farmers Market Garbanzo Beans Recalled for Glyphosate Residues

    Sprouts Farmers Market garbanzo beans (16-ounce packages, UPC 6 46670-51757 0) distributed in California are recalled due to glyphosate residues above tolerance levels.

    Product
    GARBANZO BEANS, SPROUTS FARMERS MARKET, Net Wt 16oz (1 LB) 454g units, 12 units / case. UPC 6 46670-51757 0. Distributed by Sprouts Farmers Market, Phoenix, AZ 85054.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2246-2023·2023-08-02

    COVID-19 Diagnostic Test Kits Recalled Due to Performance Reliability Issues

    Qiagen has recalled 4155 QIAstat-Dx Respiratory SARS-CoV-2 Panel kits due to decreased performance reliability. Test failures (run abortions) may require samples to be retested, potentially delaying diagnosis.

    Product
    QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214
    Category
    Medical Device
    Distribution
    14 states
  • CriticalFDA (Food)·F-1261-2023·2023-07-26

    Frozen Cherries Recalled Due to Potential Listeria Contamination

    SunOpta Grains and Foods Inc. is recalling frozen cherries sold under Great Value, Good & Gather, and Best Choice brands nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume affected products.

    Product
    Cherries packaged under the following brands and sizes: 1. Great Value Dark Sweet Cherries, Pitted. Net Wt 16 oz (1 lb) 454g, UPC 0 78742-11209 1. Keep Frozen. Distributed by: Walmart Inc., Bentonville, AR 72716 2. Good & Gather Dark Sweet Whole Pitted Cherries. Net…
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2016-2023·2023-07-26

    Olympus Bronchovideoscope Recalled for Endobronchial Combustion Risk

    Olympus is recalling 17,609 bronchovideoscope units nationwide due to complaints of endobronchial combustion during therapeutic laser procedures, which poses a fire and burn risk to patients.

    Product
    Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1267-2023·2023-07-26

    365 Whole Foods Organic Tropical Fruit Medley recalled due to Listeria contamination risk

    365 Whole Foods Market Organic Tropical Fruit Medley is recalled nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume this product.

    Product
    365 Whole Foods Market Organic Tropical Fruit Medley. Strawberries, Mangoes, Bannas & Pineapples. Net Wt 32 oz (2 lb) 907g. UPC 0 99482-45715 0. Keep Frozen. Distributed by: Whole Foods Market, Austin, TX 78703
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2012-2023·2023-07-26

    Olympus Bronchofiberscope BF Type recalled for combustion risk during laser procedures

    Olympus bronchoscopes (Models BF-PE2 and BF-TE2) are recalled due to reports of combustion inside the airway during laser-assisted medical procedures. This is an FDA Class I recall.

    Product
    Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2116-2023·2023-07-26

    Impella CP cardiac pump recalls due to motor housing interaction with stents

    Abiomed is recalling Impella CP with SmartAssist blood pumps due to risk of motor housing interaction with transcatheter aortic valve replacement devices, which can damage the pump's impeller blades and reduce blood flow.

    Product
    Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2017-2023·2023-07-26

    Olympus EVIS EXERA III Bronchovideoscope Combustion Hazard Recall

    Olympus is recalling EVIS EXERA III Bronchovideoscopes nationwide due to complaints of endobronchial combustion during therapeutic laser procedures. This FDA Class I recall affects approximately 9,684 units.

    Product
    Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1288-2023·2023-07-26

    Rose Street Patisserie Multi Grain Bread Recalled for Undeclared Sesame

    Rose Street Bread Lab is recalling 27 loaves of Rose Street Patisserie Multi Grain Bread due to undeclared sesame. Consumers with sesame allergies risk serious allergic reactions.

    Product
    Rose Street Patisserie Multi Grain Bread. Net Wt. 375 grams. 882 7th Street West, St. Paul, MN 55102
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1260-2023·2023-07-26

    365 Whole Foods Organic Blackberries Recalled for Potential Listeria Monocytogenes

    Whole Foods Market is recalling 365 brand organic blackberries due to potential Listeria monocytogenes contamination. The frozen fruit was distributed nationwide.

    Product
    365 Whole Foods Market Organic Blackberries. Net Wt 10 oz (284g), UPC 0 99482-40605 9. Keep Frozen. Distributed by: Whole Foods Market, Austin, TX 78703
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1258-2023·2023-07-26

    365 Whole Foods Market Organic Strawberries Recalled for Potential Listeria Contamination

    SunOpta Grains and Foods Inc. is recalling 365 Whole Foods Market Organic Whole Strawberries due to potential Listeria monocytogenes contamination. The frozen strawberries were distributed nationwide.

    Product
    365 Whole Foods Market Organic Whole Strawberries. Net Wt 32 oz (2 lb) 907 g, UPC 0 99482-45713 6. Keep Frozen until ready to use. Distributed By: Whole Foods Market, Austin, TX 78703
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1264-2023·2023-07-26

    Whole Foods Organic Sliced Strawberries and Bananas Recalled for Listeria Risk

    SunOpta Grains and Foods Inc. is recalling 365 Whole Foods Market Organic Sliced Strawberries & Bananas due to potential Listeria monocytogenes contamination. The frozen fruit products were distributed nationwide.

    Product
    365 Whole Foods Market Organic Sliced Strawberries & Bananas. Net Wt 32 oz (2 lb) 907g, UPC 0 99482-51908 7, Keep Frozen until ready to use. Distributed By: Whole Foods Market, Austin, TX 78703
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2151-2023·2023-07-26

    Cardiosave Hybrid Intra-Aortic Balloon Pump recalls due to unexpected device shutdown

    Datascope has recalled Cardiosave Hybrid IABP models due to tantalum capacitor failures that may cause unexpected device shutdown, interrupting life-critical cardiac therapy.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33*…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1273-2023·2023-07-26

    Frozen Tropical Mango Chunks Recalled for Listeria Risk

    Townsend Farms Inc is recalling Private Selection frozen tropical mango chunks due to potential Listeria monocytogenes contamination. The product was distributed across 16 U.S. states.

    Product
    Private Selection 48oz Tropical Mango Chunks, frozen product, 8/48 oz bags per case. UPC 0 11110 84663 1. Distributed by The Kroger Co. Cincinnati, OH
    Category
    Food
    Distribution
    16 states
  • SevereFDA (Food)·F-1259-2023·2023-07-26

    Good & Gather Frozen Blueberries Recalled for Potential Listeria Contamination

    Target's Good & Gather frozen blueberries are being recalled nationwide due to potential Listeria monocytogenes contamination affecting approximately 3,894 cases.

    Product
    Good & Gather Blueberries. Net Wt 48 oz (3lb) 1.36kg UPC 0 85239-04813 9. Keep Frozen. Distributed by Target Corporation Minneapolis, MN 55403
    Category
    Food
    Distribution
    Distributed nationwide