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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30176–30200 of 40325

  • ModerateFDA (Devices)·Z-1657-2016·2016-05-18

    Siemens ADVIA Chemistry Triglycerides Reagent Recalled for Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Triglycerides reagents because N-Acetylcysteine and Metamizole can cause falsely depressed test results.

    Product
    ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1622-2016·2016-05-18

    Siemens Recalls Dimension Vista BUN Reagent Cartridges for Inaccurate Results

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista BUN Flex reagent cartridges because they may produce inaccurate patient or quality control results.

    Product
    Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1650-2016·2016-05-18

    Neusoft NeuViz 64 CT Scanner Software Icon Mismatch Recall

    Neusoft Medical Systems is recalling seven NeuViz 64 CT scanners due to a software defect where side decubitus icons did not match the patient position description.

    Product
    NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1633-2016·2016-05-18

    Siemens Dimension Sirolimus Reagent Cartridge Recalled for Stability Failure

    Siemens Healthcare Diagnostics is recalling Dimension Sirolimus reagent cartridges due to open well instability that may cause inaccurate test results.

    Product
    Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry…
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1628-2016·2016-05-18

    Baxter Recalls GEM FlowCoupler Devices Due to Packaging Defect

    Baxter Healthcare is recalling 630 units of GEM FlowCoupler devices because the instructions for use booklet may puncture the outer Tyvek lid.

    Product
    GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1627-2016·2016-05-18

    Baxter GEM Flowcoupler Recall Due to Packaging Puncture Risk

    Baxter Healthcare is recalling 315 units of GEM Flowcoupler devices because the instructions for use booklet may puncture the outer Tyvek lid.

    Product
    GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1638-2016·2016-05-18

    Ascom Mobile Monitoring Gateway and Nurse Call Software Recall

    Ascom US, INC. is recalling 319 units of Mobile Monitoring Gateway and Unite Connect for Nurse Call due to a software malfunction that prevents automatic message forwarding if the primary module fails.

    Product
    Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Devices)·Z-1659-2016·2016-05-18

    Siemens Direct HDL Cholesterol Assay Recalled for Interference

    Siemens is recalling Direct HDL Cholesterol assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    Dimension Assays: Direct HDL Cholesterol (AHDL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1631-2016·2016-05-18

    Baxter GEM FlowCoupler Recalled Due to Packaging Lid Puncture Risk

    Baxter Healthcare is recalling 118 units of GEM FlowCoupler devices because the instructions for use booklet may puncture the outer Tyvek lid.

    Product
    GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1625-2016·2016-05-18

    Mallinckrodt Evac Tracheal Tubes Recalled for Unsealed Packaging

    Stryker is recalling four Mallinckrodt Evac Tracheal Tubes because the packaging may not be sealed, potentially compromising sterility.

    Product
    Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1630-2016·2016-05-18

    Baxter Recalls GEM FlowCOUPLER Due to Packaging Lid Puncture Risk

    Baxter Healthcare is recalling 288 units of GEM FlowCOUPLER devices because the instructions for use booklet may puncture the outer Tyvek lid.

    Product
    GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1652-2016·2016-05-18

    Siemens LDL Cholesterol Assay Recalled for Interference

    Siemens is recalling Advia Chemistry Assay: LDL Cholesterol, Direct because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    Advia Chemistry Assay: LDL Cholesterol, Direct
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1626-2016·2016-05-18

    Stryker Launcher Guiding Catheter Recalled for Unsealed Packaging

    Stryker is recalling two units of the Launcher Guiding Catheter because the device packaging may not be sealed.

    Product
    Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular system..
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1618-2016·2016-05-18

    Siemens Syva Emit Methotrexate Assay Recalled for Stability Failure

    Siemens Healthcare Diagnostics is recalling Syva Emit Methotrexate Assay units because they failed to meet the 20-hour on-board stability claim, potentially causing increased methotrexate values.

    Product
    Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1658-2016·2016-05-18

    Siemens Uric Acid Assay Recalled Due to Interference

    Siemens Healthcare Diagnostics is recalling Uric Acid assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1629-2016·2016-05-18

    Baxter Recalls GEM FlowCoupler Devices Due to Packaging Defect

    Baxter Healthcare is recalling 707 units of GEM FlowCoupler devices because the instructions for use booklet may puncture the outer Tyvek lid.

    Product
    GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1615-2016·2016-05-18

    Siemens ADVIA Centaur CP Immunoassay System Recalled for Documentation Errors

    Siemens Healthcare Diagnostics is recalling the ADVIA Centaur CP Immunoassay System because inaccuracies in the Operator's Guide may cause sample processing issues when using EZee-Nest Insert Cups.

    Product
    ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1535-2016·2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Conductivity Sensors Due to Leakage Risk

    B Braun Medical Inc is recalling 68 Dialog+ Hemodialysis Conductivity Sensors due to a potential leakage hazard. The units were distributed nationwide to various states and territories.

    Product
    Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1531-2016·2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Machines Due to Sensor Leakage Risk

    B Braun Medical Inc is recalling 370 Dialog+ Hemodialysis machines because conductivity sensors may leak. The recall covers units distributed nationwide and in Puerto Rico.

    Product
    Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1536-2016·2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Conductivity Sensors Due to Leakage Risk

    B Braun Medical Inc is recalling 147 Dialog+ Hemodialysis Conductivity Sensors due to potential leakage. The sensors are used in dialysis machines for kidney failure patients.

    Product
    Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1534-2016·2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Machines Due to Sensor Leakage Risk

    B Braun Medical Inc is recalling 90 Dialog+ Hemodialysis machines because conductivity sensors may leak. The recall covers units distributed nationwide.

    Product
    Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U Serial # 202136 and < 203837 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1532-2016·2016-05-11

    B Braun Dialog+ Hemodialysis Machines Recalled for Potential Sensor Leakage

    B Braun Medical Inc. is recalling 40 Dialog+ Hemodialysis machines due to a potential leakage issue with conductivity sensors.

    Product
    Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1533-2016·2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Machines Due to Sensor Leakage

    B Braun Medical Inc is recalling 318 Dialog+ Hemodialysis machines because conductivity sensors may leak. The recall covers units distributed nationwide.

    Product
    Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1612-2016·2016-05-11

    Philips HeartStart MRx Monitor/Defibrillator Recall for Charging Failure

    Philips is recalling 17 HeartStart MRx Monitor/Defibrillators because a faulty circuit board may prevent the device from charging.

    Product
    HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1606-2016·2016-05-11

    CareFusion Alaris PC Unit Model 8015 Recalled for Power-Up Error

    CareFusion 303, Inc. is recalling 23,397 Alaris PC units, Model 8015, because a super capacitor failure may cause a system error code at power-up.

    Product
    Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
    Category
    Medical Device
    Distribution
    Distributed nationwide