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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26376–26400 of 27722

  • HighFDA (Devices)·Z-1673-2013·2013-07-17

    Boston Scientific Recalls NephroMax Balloon Catheter Kits Due to Packaging Error

    Boston Scientific is recalling 15 NephroMax high pressure nephrostomy Balloon Catheter Kits because an incorrectly sized renal sheath was packaged with the device.

    Product
    NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1695-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw

    Biomet is recalling 26 Oxford Fixed Bearing Partial Knee components because the tibial bearing design may cause anterior impingement between bone and the poly bearing.

    Product
    REF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1701-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw

    Biomet is recalling 24 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause anterior impingement between bone and the poly bearing.

    Product
    REF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1708-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 24 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.

    Product
    REF 154217 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1703-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw

    Biomet is recalling 22 Oxford Fixed Bearing Partial Knee components because a design flaw creates a potential for anterior impingement between bone and the poly bearing.

    Product
    REF 154210 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size 6ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1661-2013·2013-07-10

    DJO VenaFlow Elite Compression Pump Recalled for Battery Fire Risk

    DJO, LLC is recalling VenaFlow Elite 30B-B and 30BI-B compression pumps due to a potential battery leakage issue that could cause a fire.

    Product
    VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1656-2013·2013-07-10

    HealthLink Recalls Biopsy Punches Due to Lack of Sterilization

    Clorox Healthcare Holdings is recalling 772,600 units of Argent Surgical Systems Biopsy Punches because they were not sterilized.

    Product
    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1647-2013·2013-07-10

    Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS Chemistry Systems Due to Electrical Short

    Ortho-Clinical Diagnostics is recalling 101 VITROS 5,1 FS Chemistry Systems because an electrical short can cause heat accumulation and melted wiring.

    Product
    1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1663-2013·2013-07-10

    Siemens Linear Accelerator Recall Due to Potential Patient Mistreatment

    Siemens is recalling specific linear accelerator systems because a difficult-to-interpret calibration issue may have resulted in the mistreatment of cancer patients.

    Product
    Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability. The intended use of the SIEMENS branded MEVATRON", ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1620-2013·2013-07-10

    Zimmer Recalls Fukuda Retractors Due to Fractures During Surgery

    Zimmer, Inc. is recalling Fukuda retractors because they fracture at the grooves during use. The recall includes 722 units distributed worldwide.

    Product
    Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1621-2013·2013-07-10

    Zimmer Recalls Fukuda Retractors Due to Fracture Risk During Surgery

    Zimmer, Inc. is recalling Fukuda-type retractors because they may fracture at the grooves during surgical use. This recall expands a 2010 action to include seven additional lots.

    Product
    Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1648-2013·2013-07-10

    Ortho-Clinical VITROS 4600 Chemistry System Recalled for Electrical Short

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because an electrical short in the connector caused heat accumulation and melted wiring.

    Product
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Product Usage: For use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1649-2013·2013-07-10

    Ortho-Clinical VITROS 5600 Integrated System Recalled for Electrical Short

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to an electrical short that caused heat accumulation and melted wiring.

    Product
    VITROS 5600 Integrated System (product code 6802413) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1651-2013·2013-07-10

    Ortho Assay Software Server Recalled Due to Electrical Short and Heat

    Ortho-Clinical Diagnostics is recalling 31 units of the ORTHO Assay Software Server because an electrical short caused heat accumulation and melted wiring.

    Product
    ORTHO¿ Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO¿ Summit System (OSS) is a modular, integrated system for use with licensed blood screening tests. Consisting of networked processors and instruments linked together via a local area network…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1650-2013·2013-07-10

    Ortho-Clinical VITROS 3600 Immunodiagnostic System Recalled for Electrical Short

    Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic Systems because an electrical short caused heat accumulation that melted wiring and connectors.

    Product
    VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1655-2013·2013-07-10

    HealthLink Biopsy Punches Recalled for Lack of Sterilization

    Clorox Healthcare Holdings is recalling 1,032,700 units of PSS Select Biopsy Punches because they were not sterilized. The products were distributed nationwide and in Canada, Mexico, and New Zealand.

    Product
    PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1646-2013·2013-07-10

    Philips CT Scanners Recalled for Image Artifacts Impairing Diagnostic Quality

    Philips is recalling Brilliance CT 64 and Ingenuity Core scanners due to software issues causing image artifacts that may impair diagnostic quality.

    Product
    Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1622-2013·2013-07-10

    Maquet YUNO Mobile Operating Table Recall for Extension Device Handle Issue

    Maquet is recalling YUNO mobile operating tables and extension devices because the handle design may allow operator skin to enter a gap.

    Product
    MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is used to support and position patients for surgical procedures immediately before, during and after the surgical phase. The table top is radio translucent and enables intraoperative use of…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1666-2013·2013-07-10

    SpineFrontier Recalls InSpan Inserter Assemblies Due to Set Screw Deformation

    SpineFrontier, Inc. is recalling InSpan Inserter assemblies because a set screw may become deformed. The recall covers 61 units distributed worldwide.

    Product
    InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1654-2013·2013-07-10

    HealthLink Biopsy Punches Recalled for Lack of Sterilization

    Clorox Healthcare Holdings is recalling HealthLink Biopsy Punches because they were not sterilized. The recall affects 1,044,600 units distributed in the US, Canada, Mexico, and New Zealand.

    Product
    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1618-2013·2013-07-10

    Bard StatLock CV Plus Stabilization Devices Recalled for Assembly Error

    Bard Access Systems is recalling StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly that may cause skin irritation or catheter mis-orientation.

    Product
    StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock¿ device provides stabilization for compatible medical tubes and catheters.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1652-2013·2013-07-10

    Braemar Recalls Lithium Thionyl Battery Packs for ER920 Wireless Event Recorders

    Braemar, Inc. is recalling 3,286 non-rechargeable lithium thionyl battery packs used with ER920 Wireless Series Arrhythmia Event Recorders due to a battery-related incident.

    Product
    Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1640-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls Reprocessed Medical Devices

    Surgical Instrument Service And Savings, Inc. is recalling 34 reprocessed medical devices because the sterile barrier seal became compromised, allowing product to fall out of the pouch.

    Product
    - ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511 - ENDO-SCRUB 2, (1) Sheath, 0 Degree, For K. Storz, Medtronic Sharpsite AC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1630-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls 73 Medical Devices with Compromised Sterile Seals

    Surgical Instrument Service And Savings, Inc. is recalling 73 surgical instruments and accessories because their sterile seals may be compromised, allowing product to fall out of the pouch.

    Product
    - Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447 - Cannulated Drill Bit, Quick Coupling, For 3.5 & 4mm Cannulated Screws, 1.35mm Cannulation 2.7mm x 160mm Ref. 310.67 Lot 122289 - Hall MicroChoice, Oscillating Blade, Fine, Flat, Stainless…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1617-2013·2013-07-10

    Biosense Webster Recalls 20-Pole LASSO Nav Catheter Eco Due to Calibration Error

    Biosense Webster is recalling 10 units of the 20-Pole LASSO Nav Catheter Eco because incorrect calibration causes the CARTO 3 System to display them as 10-Pole devices.

    Product
    20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.
    Category
    Medical Device
    Distribution
    3 states