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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

11926–11950 of 27471

  • 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-1382-2021·2021-04-21

    Sunstar Butler Clear Dip Recalled for Burkholderia Contamination

    Sunstar Americas is recalling 19,471 bottles of Butler Clear Dip due to potential contamination with Burkholderia contaminans.

    Product
    SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
    Category
    Food
    Distribution
    0 states
  • 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
  • SevereFDA (Devices)·Z-1343-2021·2021-04-14

    Fenwal Recalls Amicus MNC Apheresis Kits Due to Centrifuge Pack Leaks

    Fenwal Inc is recalling specific lots of Amicus MNC Apheresis Kits because centrifuge packs may leak blood during therapeutic procedures.

    Product
    Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1378-2021·2021-04-14

    Becton Dickinson Recalls Martin-Lewis Agar Due to Fungal Growth

    Becton Dickinson is recalling Martin-Lewis Agar plates because they show heavy fungal growth, which may delay the diagnosis of Neisseria infections.

    Product
    BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221557
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1374-2021·2021-04-14

    Arrow OnControl Bone Lesion Biopsy System Recalled for Insertion Defect

    Arrow International is recalling OnControl Bone Lesion Biopsy Systems because the ejector rod may not insert properly, preventing sample collection.

    Product
    Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of the vertebral body and bone lesions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1332-2021·2021-04-14

    Tenacore Alaris Infusion Pump Bezel Recall for Cracking Risk

    Tenacore LLC is recalling Alaris Infusion Pump 8100 bezels because they may crack or separate, potentially causing infusion errors.

    Product
    Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1366-2021·2021-04-14

    Sharp Medical Reactor and Sleeve Recalled for Sterile Barrier Defects

    Sharp Medical Products is recalling 129 units of Reactor and Sleeve REF 100-36-01 due to holes, punctures, or deep creases in the sterile barrier.

    Product
    SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1379-2021·2021-04-14

    Howmedica Recalls Specialty Triathlon TS Trial Cutting Guides Due to Fracture Risk

    Howmedica Osteonics Corp. is recalling Specialty Triathlon TS Trial Cutting Guides because the posterior condyle may fracture during transport or surgery.

    Product
    Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer. Catalog Number: I-K3834CG00 Specialty Triathlon TS Trial Cutting Guide Set…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1344-2021·2021-04-14

    Fenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks

    Fenwal Inc is recalling 2,466 Amicus Exchange Kits because centrifuge packs may leak blood during therapeutic procedures.

    Product
    Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1337-2021·2021-04-14

    Medtronic HVAD Controller Power Cables Recalled for Port Damage Risk

    Heartware, Inc. is recalling Medtronic HVAD Controller power and data cables due to a risk of damaging controller ports from cable misalignment.

    Product
    Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US 2. Medtronic HVAD Controller DC Adapter, Product Number…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1372-2021·2021-04-14

    Beckman Coulter MicroScan WalkAway-40 Plus Reconditioned Instruments Recalled

    Beckman Coulter is recalling six reconditioned MicroScan WalkAway-40 Plus instruments due to a shortened reagent draw straw that may cause reagent dispensing failures and organism misidentification.

    Product
    MicroScan WalkAway-40 plus Reconditioned Instrument
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1376-2021·2021-04-14

    ROi CPS Recalls Regard Custom Cardiovascular Procedure Kits

    ROi CPS LLC is recalling 16 Regard custom cardiovascular procedure kits because drape slits may breach the sterile barrier.

    Product
    Regard, Item Number 830067009, custom cardiovascular procedure kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1345-2021·2021-04-14

    Fenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks

    Fenwal Inc is recalling 24 units of Amicus Exchange Kits because centrifuge packs may leak blood during therapeutic procedures.

    Product
    Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1331-2021·2021-04-14

    Tenacore Recalls Alaris Infusion Pump Modules with Impacted Bezel Repair Parts

    Tenacore LLC is recalling 474 Alaris Infusion Pump Modules, Model 8100, serviced with non-original bezel repair parts. The parts may crack or separate, potentially causing infusion errors.

    Product
    Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1346-2021·2021-04-14

    Siemens Ysio X.pree Digital X-Ray System Recalled for Image Mismatch

    Siemens is recalling 12 Ysio X.pree digital X-ray systems because a software issue may display a previous patient's image during recovery, potentially impacting diagnosis.

    Product
    Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1370-2021·2021-04-14

    Beckman Coulter Recalls MicroScan WalkAway-40 plus Instruments

    Beckman Coulter is recalling 16 MicroScan WalkAway-40 plus instruments because a shortened reagent straw may cause reagent dispensing failures, leading to organism misidentification or quality control failures.

    Product
    MicroScan WalkAway-40 plus Instrument
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1377-2021·2021-04-14

    BD BBL Martin-Lewis Agar Recalled for Misformulation and Fungal Growth

    Becton Dickinson is recalling BD BBL Martin-Lewis Agar due to misformulation causing heavy fungal growth, which may delay the diagnosis of Neisseria infections.

    Product
    BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221558
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1369-2021·2021-04-14

    Hologic Recalls Panther Fusion Tube Trays Due to Potential Leakage

    Hologic is recalling 1,355 Panther Fusion Tube Trays because they may leak, potentially causing false positive, false negative, or invalid patient results.

    Product
    Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1348-2021·2021-04-14

    Fujifilm Synapse PACS Recalled for Potential Wrong Patient Information Display

    Fujifilm Medical Systems is recalling Synapse PACS software because it may display incorrect patient information in the viewer or PowerJacket.

    Product
    Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).
    Category
    Medical Device
    Distribution
    Distributed nationwide