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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30251–30275 of 40449

  • HighFDA (Devices)·Z-1623-2016·2016-05-18

    Stanmore Distal Femoral Replacement Recalled for Incorrect Component

    Stanmore Implants Worldwide Ltd. is recalling one custom-made distal femoral replacement implant due to the use of an incorrect component during manufacturing.

    Product
    Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1665-2016·2016-05-18

    Siemens Dimension Vista Triglyceride Assay Recalled for Interference

    Siemens is recalling Dimension Vista Triglyceride assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    Dimension Vista Assays: Triglycerides (TRIG)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1621-2016·2016-05-18

    Applied Medical Direct Drive Clip Applier Recalled for Inconsistent Application

    Applied Medical Resources Corp is recalling Direct Drive Clip Applier CA090 units due to inconsistent clip application that may lead to unoccluded vessels.

    Product
    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1654-2016·2016-05-18

    Siemens ADVIA Chemistry Enzymatic Creatinine 2 Recalled for Interference

    Siemens is recalling ADVIA Chemistry Enzymatic Creatinine 2 reagents because N-Acetylcysteine and Metamizole can cause falsely depressed test results.

    Product
    ADVIA CHEMISTRY ENZYMATIC CREATININE_2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1653-2016·2016-05-18

    Siemens Recalls Direct HDL Cholesterol Assay Due to Interference

    Siemens Healthcare Diagnostics is recalling the Advia Chemistry Assay: Direct HDL Cholesterol due to potential falsely depressed results caused by NAC or Metamizole interference.

    Product
    Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1660-2016·2016-05-18

    Siemens Dimension Enzymatic Creatinine Assay Recalled for Interference

    Siemens Healthcare Diagnostics is recalling Dimension Enzymatic Creatinine assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    Dimension Assays: ENZYMATIC CREATININE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1656-2016·2016-05-18

    Siemens Recalls Advia Chemistry Assay: Lactate Due to Interference

    Siemens Healthcare Diagnostics is recalling Advia Chemistry Assay: Lactate units because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    Advia Chemistry Assay: Lactate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1662-2016·2016-05-18

    Siemens Uric Acid Assay Recalled Due to Drug Interference

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

    Product
    Dimension Assays: Uric Acid (URCA)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1651-2016·2016-05-18

    Siemens recalls Advia Chemistry Assays due to NAC and Metamizole interference

    Siemens Healthcare Diagnostics is recalling Advia Chemistry Assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1655-2016·2016-05-18

    Siemens ADVIA Chemistry Glucose Oxidase Assay Recalled for Interference

    Siemens is recalling ADVIA Chemistry Glucose Oxidase Assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1663-2016·2016-05-18

    Siemens Direct HDL Cholesterol Assay Recalled for Interference

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

    Product
    Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1649-2016·2016-05-18

    Medtronic Recalls Kangaroo Connect Enteral Feeding Pumps Due to Alarm Failure

    Medtronic is recalling 145 Kangaroo Connect Enteral Feeding Pumps because occlusion alarms may fail to sound, posing a risk to patients in hospital settings.

    Product
    Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
    Category
    Medical Device
    Distribution
    0 states
  • 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