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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27726–27750 of 40233

  • HighFDA (Devices)·Z-1061-2017·2017-02-01

    Philips Recalls Velara Generators Due to Potential System Lockup

    Philips is recalling 59 Velara Generators used with Allura Xper Systems because the devices may lock up. The recall is voluntary and covers units in the US and internationally.

    Product
    Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura XPER FD20 Biplane)
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1106-2017·2017-02-01

    Philips Cisco 3850 Switch Recall Due to Monitoring Loss Risk

    Philips is recalling Cisco 3850 switches used with IntelliVue systems because they may experience a loss of centralized monitoring.

    Product
    Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1083-2017·2017-02-01

    Atrium Medical Oasis Single Drain Recalled for Non-Sterile Packaging

    Atrium Medical is recalling Oasis Single Drains because the outer packaging is not sterile, posing a risk of infection.

    Product
    Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain with in-line connector 3600-150 Oasis single drain with in-line connector and Pre-connected 2550 ATS Bag Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum.  To help…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1062-2017·2017-02-01

    Philips Velara Generator Recall for System Lockup Risk

    Philips is recalling 59 Velara Generators with old firmware used with the Integris BH5000 because the system may lock up.

    Product
    Velara Generator with an old Firmware version used with the Philips Integris BH5000
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1091-2017·2017-02-01

    Merge Hemo software recall due to potential connection issues

    Merge Healthcare is recalling Merge Hemo software versions 6.10 through 9.40.3 because the Hemo Monitor may fail to communicate with the Client PC during power-up.

    Product
    Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1096-2017·2017-02-01

    Hitachi Oasis MRI C-Spine Coil Recalled Due to Overheating Balun

    Hitachi Medical Systems America Inc is recalling 180 Hitachi Oasis MRI System C-Spine Coils because the coil balun was found to be hot to the touch after an exam.

    Product
    Hitachi Oasis MRI System - C-Spine Coil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1094-2017·2017-02-01

    Baxter Recalls Phoenix Dialysis Machine Preventive Maintenance Kits

    Baxter Healthcare is recalling Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone connectors that may cause fluid leaks during dialysis.

    Product
    Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1090-2017·2017-02-01

    Roche Recalls Five cobas p 612 Pre-analytical Systems in Texas and Washington

    Roche Diagnostics is voluntarily recalling five cobas p 612 pre-analytical systems in Texas and Washington. The recall was initiated on December 27, 2016, and classified as Class II.

    Product
    cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1092-2017·2017-02-01

    Roche Tina-Quant CRP Latex Test System Recalled for Low Results

    Roche is recalling Tina-Quant CRP Latex High Sensitive test kits due to potential under-recovery of results, which may lead to incorrect cardiovascular risk assessments.

    Product
    Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in-vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1069-2017·2017-02-01

    Binding Site IgG4 Reagent Kits Recalled for Inaccurate Results

    The Binding Site Group is recalling Human IgG4 Subclass Liquid Reagent Kits because they may yield falsely low results for samples with extremely high IgG4 levels.

    Product
    Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"6000 This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1080-2017·2017-02-01

    Atrium Medical Recalls Dual Chamber Ocean Drains Due to Sterility Issues

    Atrium Medical is recalling Dual Chamber Ocean Drains because the outer packaging is not sterile. The recall affects units with expiration dates prior to October 2019.

    Product
    Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual chamber, in-line connectors and suction control stopcock (2 Patient Tubes) 2020-100 Ocean dual chamber with in-line connectors and no suction control stopcock (2 Patient Tubes) 2020-300 Ocean dual…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1070-2017·2017-02-01

    Binding Site IgG4 Reagent Kits Recalled for Inaccurate Results

    The Binding Site Group is recalling Human IgG4 Subclass Liquid Reagent Kits because they may yield spuriously low results for samples with extremely high IgG4 levels.

    Product
    Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917 and Hitachi Modular P Product Code LK009.H/LK001.H This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1079-2017·2017-02-01

    Atrium Medical Ocean Drains Recalled Due to Non-Sterile Outer Packaging

    Atrium Medical is recalling Ocean Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.

    Product
    Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control stopcock 2002-040 Ocean single drain, in-line connector and suction control stopcock, Pedi connector in bag on back of the drain 2002-050 Ocean single drain…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1067-2017·2017-02-01

    Binding Site Human IgG Subclass Kit Recalled for Inaccurate Results

    The Binding Site Group is recalling Human IgG Subclass Kits because they may produce falsely low results for patients with extremely high IgG4 levels.

    Product
    Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.IM This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1082-2017·2017-02-01

    Atrium Medical Recalls Ocean Blood Recovery Drains Due to Sterility Issues

    Atrium Medical is recalling Ocean Blood Recovery Drains because the outer packaging is not sterile. The recall affects units worldwide with expiration dates prior to October 2019.

    Product
    Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain with in-line connector and suction control stopcock 2050-300 Ocean Blood Recovery drain with suction control stopcock, no in-line connector 2052-000 Ocean Double Blood Recovery drain…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1068-2017·2017-02-01

    Binding Site IgG4 Subclass Kit Recalled for Inaccurate Results

    The Binding Site Group is recalling Human IgG4 Subclass kits because high IgG4 levels can cause spuriously low results.

    Product
    Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1093-2017·2017-02-01

    Acumedia Tryptic Soy Agar Recalled Due to Precipitate Formation

    Acumedia is recalling Tryptic Soy Agar because precipitate may form in plates, potentially leading to inaccurate microbial counts.

    Product
    Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-1078-2017·2017-02-01

    Sekisui Diagnostics Ammonia L3K Assay Recalled for Performance Issues

    Sekisui Diagnostics is recalling specific lots of the Ammonia L3K Assay because atypical optical density decreases may impact performance at the high end of the linear range.

    Product
    Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1100-2017·2017-02-01

    PerkinElmer AutoDELFIA Plate Processor Recalled for Potential Loading Failures

    PerkinElmer is recalling AutoDELFIA Plate Processors with Version 3.0 software due to potential plate loading failures that could affect clinical assay results.

    Product
    AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1057-2017·2017-02-01

    On-X Chord-X Chordal Sizer Recalled for Manufacturing Defects

    On-X Life Technologies is recalling 45 units of the Chord-X Chordal Sizer due to manufacturing defects including burrs, particulate, hair, and assembly errors.

    Product
    Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve…
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1086-2017·2017-02-01

    Atrium Medical Recalls Oasis Blood Recovery Drains Due to Sterility Issues

    Atrium Medical is recalling Oasis Blood Recovery Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.

    Product
    Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood Recovery drain with in-line connector 3652-100 Oasis Double Blood Recovery drain with in-line connectors - 2 patient lines connected by one Y connector Product Usage: To evacuate air and/or fluid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1087-2017·2017-02-01

    Atrium Medical 400 Series Express Drains Recalled for Non-Sterile Packaging

    Atrium Medical is recalling 400 Series Express Drains because the outer packaging is not sterile. The recall affects approximately 1.4 million cases distributed worldwide.

    Product
    Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection drain with in-line connector 4000-100P Express PreFilled Chest Drain 4020-100N Express dual chamber drain with in-line connectors ( 2 Patient Tubes) 4050-100N Express Blood Recovery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1072-2017·2017-02-01

    Binding Site IgG Subclass Reagent Kits Recalled for Inaccurate Results

    The Binding Site Group is recalling Human IgG Subclass Liquid Reagent Kits because high IgG4 levels can cause spuriously low test results.

    Product
    Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1071-2017·2017-02-01

    Binding Site IgG4 Reagent Kits Recalled for Inaccurate Results

    The Binding Site Group is recalling Human IgG4 Subclass Liquid Reagent Kits because they may yield spuriously low results for samples with extremely high IgG4 levels.

    Product
    Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product Code: NK009.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins…
    Category
    Medical Device
    Distribution
    6 states