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.

23501–23525 of 88183

  • HighFDA (Food)·F-1421-2022·2022-07-13

    Soft Ripened Brie D'Amir Cheese Recalled Due to Listeria Risk

    Paris Brothers Inc recalls Brie D'Amir soft ripened cheese due to Listeria detected in environmental samples. The affected product was distributed to wholesale warehouses and retail food establishments.

    Product
    SOFT RIPENED CHEESE - DOUBLE CREME BRIE D'AMIR Imported by Epicure Foods Corp. Flanders NJ, 07836 INGREDIENTS: Pasteurized Milk, Salt, Lactic Ferments, Enzymes, Ripening Cultures. PRODUCT OF FRANCE Carton Label (not available to consumers): ITEM ID: 02050003 PARIS…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1335-2022·2022-07-13

    VERIGENE Enteric Pathogens Test may yield false negative results

    Luminex Corporation is recalling VERIGENE Enteric Pathogens tests worldwide due to potential false negative results caused by hydrophobic characteristics of the sampling swab. The defect could lead to missed detection of infections in stool specimens.

    Product
    VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1186-2022·2022-07-13

    Estriol Vaginal Cream Recalled Due to Insanitary Manufacturing Conditions

    Wedgewood Village Pharmacy is recalling Estriol vaginal cream nationwide due to insanitary manufacturing conditions and lack of processing controls identified during an FDA inspection.

    Product
    Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1420-2022·2022-07-13

    Raw milk cheese recalled due to Listeria contamination

    Paris Brothers Inc is recalling WIEBE DAIRY Raw Milk Cheese because environmental samples tested positive for Listeria. The product was distributed to wholesale and retail locations.

    Product
    WIEBE DAIRY RAW MILK CHEESE Ingredients: Grade A Raw milk, salt, cheese culture, enzyme, annatto Cottonwood River RESERVE www.jasonwiebedairy.com Durham, KS 67438 Plant # 20-037 Carton Label (not available to consumers) ITEM ID: 02000002 PARIS BROTHERS, INC. 8800 NE…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1401-2022·2022-07-13

    Bix Produce diced spinach recalled for plastic contamination

    Bix Produce Company LLC is recalling diced spinach due to plastic contamination. The recall affects 1,181 cases distributed in Wisconsin with use-by dates between January and June 2022.

    Product
    Bix Produce Diced Spinach, Item # 15939. packaged in 2lb bags, with 5 bags per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1331-2022·2022-07-13

    Omnera 400T Radiographic System Recalled for Potential Overhead Crane Malfunction

    Arcoma AB is recalling 71 Omnera 400T radiographic systems because liquid ingress in the display handles may cause electrical short circuits and uncontrolled movement of the overhead tube crane.

    Product
    Omnera 400T Digital Radiographic System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1332-2022·2022-07-13

    Omnera 400A Digital Radiographic System: Electrical Short Circuit Hazard

    Arcoma AB recalls 47 Omnera 400A Digital Radiographic Systems due to potential electrical short circuits that could cause uncontrolled movement of the overhead tube crane.

    Product
    Omnera 400A Digital Radiographic System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1400-2022·2022-07-13

    SoDelicious DairyFree Frozen Dessert Cones Recalled for Undeclared Peanut

    SoDelicious DairyFree Wondermilk Salted Caramel Sundae cones are recalled due to peanut contamination. Some cartons mistakenly contain peanut pieces, posing a serious risk to consumers with peanut allergies.

    Product
    SoDelicious DairyFree Wondermilk Dairy Free Frozen Dessert Salted Caramel Sundae, 3 - 4 fl oz (12 fl oz) cones per carton. UPC 0 36632 07821 6 Manufactured by/for: So Delicious Dairy Free, Eugene, OR 97402. Keep frozen.
    Category
    Food
    Distribution
    14 states
  • HighFDA (Food)·F-1427-2022·2022-07-13

    Cervasi Pecorino Romano Cheese Recalled Due to Listeria

    Cervasi Pecorino Romano Cheese is being recalled by Paris Brothers Inc due to Listeria contamination detected in environmental samples at the production facility.

    Product
    PRODUCT OF ITALY Cervasi PECORINO ROMANO CHEESE Ingredients: Sheep's Milk, Rennet, Salt. Contains: Sheep's Milk Imported by Paris Brothers, Inc. Kansas City, MO 64161 Cervasi.com Carton Label (not available to consumers) ITEM ID: 06010002 PARIS BROTHERS, INC 8800 NE…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-1185-2022·2022-07-13

    Estriol Vaginal Cream Recalled for Insanitary Manufacturing Conditions

    Wedgewood Village Pharmacy is recalling Estriol 1mg/gm Vaginal Cream due to insanitary manufacturing conditions and lack of adequate processing controls identified during FDA inspection. The product was distributed nationwide.

    Product
    Estriol 1mg/gm, Vaginal Cream, 30 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1345-2022·2022-07-13

    CELLSEARCH Circulating Tumor Cell Kit Recalled for False Positive Risk

    Menarini Silicon Biosystems is recalling CELLSEARCH Circulating Tumor Cell Kit due to potential false positive results in patient samples. The device may generate unassigned events that could affect diagnostic accuracy.

    Product
    CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood Part Number: 7900001
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Food)·F-1425-2022·2022-07-13

    Colby Jack Cheese Recalled for Potential Listeria Contamination

    Paris Brothers Inc is recalling Colby Jack Cheese due to environmental samples testing positive for Listeria. Affected product has lot code 05042022 and best-by date of August 3–4, 2022.

    Product
    COLBY JACK CHEESE Ingredients: Pasteurized Milk, Cheese Culture, Salt, Enzymes and Annatto. DISTRIBUTED BY PARIS BROTHERS, INC. KANSAS CITY, MO 64161 UPC: 033954252232 Net wt. 1 LB(16OZ) 453G Carton Label (not available to consumers) ITEM ID: 02201803 PARIS…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1340-2022·2022-07-13

    Siemens Dimension LTNI Cardiac Troponin Test Positive Bias Recall

    Siemens is recalling the Dimension LTNI cardiac troponin-I test due to positive bias in Lithium Heparin plasma samples, which may cause false-positive results and inappropriate medical intervention.

    Product
    Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444896/RF521
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1423-2022·2022-07-13

    Milton Creamery Tomato Garlic Cheddar Cheese Recalled Due to Listeria

    Milton Creamery Tomato Garlic Cheddar Cheese, made by Paris Brothers Inc, is being recalled because Listeria was detected in environmental samples. The affected product was distributed to wholesale warehouses, grocery stores, and food service establishments.

    Product
    MILTON CREAMERY Tomato Garlic Cheddar Cheese Pasteurized Cow's Milk, Cultures, Salt, Veg., Rennet, Minced Tomatoes, Garlic Granules www.miltoncreamery.com 641-656-4094 Carton Label (not available to consumers) ITEM ID: 02074713 PARIS BROTHERS, INC 8800 NE UNDERGROUND DR…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1337-2022·2022-07-13

    Laboratory Control Material Recalled for Insufficient Glycine Concentration

    Chromsystems has recalled MassCheck Amino Acid, Acylcarnitines dried blood controls (batch 2821) for insufficient glycine concentration. This may affect laboratory test accuracy.

    Product
    MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-1426-2022·2022-07-13

    Pepper Jack Cheese Recalled Due to Listeria Environmental Contamination Risk

    Paris Brothers Inc recalled Pepper Jack Cheese after environmental samples from the production facility tested positive for Listeria.

    Product
    PEPPER JACK CHEESE Monterey Jack Cheese with Peppers Ingredients: Pasteurized Milk, Jalapeno Peppers, Cheese Culture, Salt, and Enzymes. DISTRIBUTED BY PARIS BROTHERS, INC. KANSAS CITY, MO 64161 UPC: 033954252256 Net wt. 1 LB(16OZ) 453G Carton Label (not available to…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1333-2022·2022-07-13

    GE Centricity Medical Imaging Software Displays Inaccurate Measurements

    GE Centricity Universal Viewer Zero Footprint software can display inaccurate measurements on medical images. This Class II recall affects approximately 1,934 units distributed worldwide.

    Product
    GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-1183-2022·2022-07-13

    Boric Acid 600 mg Capsules Recalled for Insanitary Manufacturing Conditions

    The FDA has recalled Boric Acid 600 mg capsules (Lot #000-03868160, Exp: 09/14/22) manufactured by Wedgewood Village Pharmacy due to insanitary conditions and lack of processing controls observed during FDA inspection. The recalled product was distributed nationwide.

    Product
    Boric Acid 600 mg capsules, 14 capsules per box, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1343-2022·2022-07-13

    Fluoroscopic X-Ray System Stand Movement May Be Blocked During Use

    Siemens Artis and Artis Q.zeego fluoroscopic X-ray systems may lose stand mobility if the robotic control system's BIOS battery discharges at startup. Field service is required to restore function.

    Product
    Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1334-2022·2022-07-13

    Verigene CDF Nucleic Acid Test recalled for potential false negative results

    Luminex Corporation is recalling the Verigene CDF Nucleic Acid Test due to potential false negative results caused by the swab's hydrophobic characteristics, which could result in missed positive diagnoses.

    Product
    Verigene CDF Nucleic Acid Test, Part No. 30-002-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1180-2022·2022-07-13

    Prescription Drug Recall: Enalapril Maleate Due to Manufacturing Deviations

    Golden State Medical Supply Inc. is recalling 1,424 bottles of Enalapril Maleate 20 mg tablets due to Current Good Manufacturing Practice deviations. The affected lot numbers have expiration dates ranging from March 2022 to December 2022.

    Product
    ENALAPRIL MALEATE — ENALAPRIL MALEATE (ENALAPRIL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1174-2022·2022-07-13

    Eszopiclone sleep medication recalled nationwide for shortfill packaging defect

    Macleods Pharma USA Inc is recalling Eszopiclone 1 mg tablets due to shortfill—customers reported one to three missing tablets from 30-count bottles. Affected lot BEK2009A (exp. 11/2023) was distributed nationwide and to Puerto Rico.

    Product
    ESZOPICLONE — ESZOPICLONE (ESZOPICLONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1324-2022·2022-07-13

    Intervertebral fusion device recalled for outer carton labeling discrepancy

    DePuy Spine's EIT CIF intervertebral fusion cage (46 units, Part No. CUI8070S) is recalled due to a labeling discrepancy where the outer carton label does not match the labels on the product packaging and patient materials.

    Product
    EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) Part Number: CUI8070S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1323-2022·2022-07-13

    EIT CIF Cage Intervertebral Fusion Device Carton Labeling Mismatch Recall

    DePuy Spine is recalling 61 units of the EIT CIF cage spinal fusion device due to a labeling mismatch. The outer carton label does not match the labels on the blister packages and patient information labels.

    Product
    EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD). Part Number: CUI8060L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1178-2022·2022-07-13

    Enalapril Maleate Tablets Recalled Due to Manufacturing Practice Deviations

    Golden State Medical Supply Inc. is recalling Enalapril Maleate Tablets due to manufacturing practice deviations. The voluntary recall involves 9,058 units distributed nationwide.

    Product
    ENALAPRIL MALEATE — ENALAPRIL MALEATE (ENALAPRIL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide