The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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14776–14800 of 39988

  • HighFDA (Devices)·Z-1413-2021·2021-04-21

    Roche Recalls cobas SARS-CoV-2 and Influenza Assay Reagents

    Roche is recalling cobas SARS-CoV-2 & Influenza A/B assay reagents because they may produce invalid or false positive results.

    Product
    cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1393-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch

    Siemens Healthcare Diagnostics is recalling ADVIA 2120i automated hematology analyzers because 14-character barcodes may cause sample identification mismatches.

    Product
    ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1421-2021·2021-04-21

    Krishe Dasky Disposable Sampling Tubes Recalled for Missing Validation Data

    Krishe Inc is recalling Dasky Disposable Sampling Tubes because verification and validation data for the virus transport medium was not provided to the FDA prior to sale.

    Product
    Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CE
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1398-2021·2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Sample Identification Mismatch

    Siemens Healthcare Diagnostics is recalling 195 ADVIA 2120 automated hematology analyzers worldwide due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2021·2021-04-21

    VGlove Nitrile Examination Gloves Recalled for Containing Latex

    HUBO International is recalling VGlove Nitrile examination gloves because they contain latex instead of nitrile, posing a risk to latex-allergic individuals.

    Product
    VGlove NITRILE *** Protect Your Life 100 Patient examination gloves
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1392-2021·2021-04-21

    Siemens ADVIA 2120i Analyzer Recalled for Sample Identification Mismatch

    Siemens Healthcare Diagnostics is recalling ADVIA 2120i automated hematology analyzers because 14-character barcodes may cause sample identification mismatches.

    Product
    ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1397-2021·2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Barcode Mismatch

    Siemens Healthcare is recalling 283 ADVIA 2120 Dual Aspirate Autosamplers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1401-2021·2021-04-21

    Siemens ADVIA 2120i Autosampler Recalled for Barcode Mismatch Risk

    Siemens is recalling 1,452 ADVIA 2120i Dual Aspirate Autosamplers worldwide due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1419-2021·2021-04-21

    FDA Recalls 222 Units of Covidien Tri-Staple 2.0 Reinforced Intelligent Reloads

    FDA is recalling 222 units of Covidien Tri-Staple 2.0 Reinforced Intelligent Reloads due to a potential packaging defect that could compromise sterility and increase infection risk.

    Product
    Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It…
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1402-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch

    Siemens is recalling 33 ADVIA 2120i automated hematology analyzers because a potential sample identification mismatch may occur with 14-character barcodes.

    Product
    ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1400-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Sample Identification Mismatch

    Siemens Healthcare Diagnostics is recalling 969 ADVIA 2120i automated hematology analyzers because 14-character barcodes may cause sample identification mismatches.

    Product
    ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1403-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch

    Siemens Healthcare is recalling 27 ADVIA 2120i hematology analyzers because a software defect may cause sample identification mismatches with 14-character barcodes.

    Product
    ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1386-2021·2021-04-21

    Siemens ADVIA 2120 Hematology Analyzer Recalled for Sample Identification Mismatch

    Siemens Healthcare Diagnostics is recalling ADVIA 2120 automated hematology analyzers due to potential sample identification mismatches with 14-character barcodes.

    Product
    ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1427-2021·2021-04-21

    RayStation Software Recall Due to Potential Data Synchronization Errors

    RaySearch Laboratories is recalling RayStation software versions 9A, 9B, 10A, and 10B because flags edited in RayCare may not update in RayTreat.

    Product
    RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1415-2021·2021-04-21

    EOS Imaging Recalls EOSedge Systems Due to Measurement Errors

    EOS Imaging is recalling 11 EOSedge systems because they may produce inaccurate 2D measurements and image resizing errors when patients are not positioned antero-posteriorly.

    Product
    The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific area (spine, lower limbs, etc.). EOSedge consists of a gantry and an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1409-2021·2021-04-21

    OriGen Evolve Cell Culture Bags Recalled for Incorrect Phthalate Labeling

    OriGen Biomedical is recalling Evolve Cell Culture Bags because they were incorrectly labeled as free of phthalates.

    Product
    Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1423-2021·2021-04-21

    Krishe Dasky Disposable Sampling Tubes Recalled for Missing Validation Data

    Krishe Inc is recalling Dasky Disposable Sampling Tubes because verification and validation data for the virus transport medium was not provided to the FDA prior to sale.

    Product
    Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1424-2021·2021-04-21

    Remel Haemophilus Test Medium Recalled Due to Growth Issues

    Remel Inc is recalling 408 units of Haemophilus Test Medium because lighter-than-normal growth may make antimicrobial test zones difficult to measure.

    Product
    Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1416-2021·2021-04-21

    Becton Dickinson Recalls BioGX SARS-CoV-2 Reagents for Sealed Tube Defect

    Becton Dickinson is recalling BioGX SARS-CoV-2 Reagents for BD MAX System because rehydration buffer tubes were not adequately sealed, potentially causing unresolved test results.

    Product
    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1408-2021·2021-04-21

    Biomerieux Recalls VIDAS CMV IgM Tests Due to Calibration Issues

    Biomerieux is recalling VIDAS CMV IgM test kits due to reported calibration issues. The recall affects 18,705 kits distributed nationwide and internationally.

    Product
    VIDAS¿ CMV IgM 30 Tests
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1425-2021·2021-04-21

    Remel Haemophilus Test Medium Recalled for Reduced Organism Growth

    Remel Inc is recalling 19 units of Haemophilus Test Medium because lighter-than-normal growth may make antimicrobial test zones difficult to measure.

    Product
    Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1430-2021·2021-04-21

    Boston Scientific Recalls MAMBA Microcatheters for Labeling Errors

    Boston Scientific is recalling 63 MAMBA Microcatheters due to incorrect labeling and packaging. The devices were distributed nationwide and internationally.

    Product
    MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1429-2021·2021-04-21

    Boston Scientific Recalls MAMBA Flex 135 Microcatheters for Labeling Errors

    Boston Scientific is removing specific batches of MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.

    Product
    MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1406-2021·2021-04-21

    Centinel Spine Recalls Prodisc C Devices Missing Orientation Marking

    Centinel Spine is recalling 49 Prodisc C cervical disc prostheses because the 'UP' orientation marking is missing from the superior plate.

    Product
    Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD), Part number: 09.820.055S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1380-2021·2021-04-21

    Arthrex Recalls Tibial Opening Wedge Osteotomy Plates Due to Processing Error

    Arthrex, Inc. is recalling 32 units of Tibial Opening Wedge Osteotomy Plates because five parts were incorrectly processed as a different model.

    Product
    Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide