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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17051–17075 of 27505

  • HighFDA (Devices)·Z-3192-2018·2018-09-26

    Invivo Xper Flex Cardio Physiomonitoring System Recalled for Firmware Error

    Invivo Corporation is recalling 38 Xper Flex Cardio Physiomonitoring Systems distributed in the Netherlands due to incorrect firmware that may cause inaccurate ECG and heart rate displays.

    Product
    Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2781-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors

    Degania Silicone, Ltd. is recalling 4,372 temperature sensing Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature sensing catheter 14FR, Catalogue Number 102203101463DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3015-2018·2018-09-26

    Ventana NEXES VEN IVIEW DAB Detection Kit Recall for Leaking Dispensers

    Ventana Medical Systems is recalling NEXES VEN IVIEW DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative IHC results.

    Product
    NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3186-2018·2018-09-26

    Polymedco PATHFAST NTproBNP Cartridges Recalled for Measurement Bias

    Polymedco is recalling 272 PATHFAST NTproBNP cartridges due to a manufacturing defect that may cause measurement values to be 12% to 20% higher than actual.

    Product
    PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole…
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-3209-2018·2018-09-26

    Exactech Recalls Optetrak Logic CC Stem Extension Due to Thread Defects

    Exactech is recalling one unit of the Optetrak Logic CC Stem Extension because it may have non-conforming internal threads.

    Product
    Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2991-2018·2018-09-26

    Mobius AIRO Mobile CT System Recalled for Software Fault

    Mobius Imaging is recalling 147 AIRO Mobile CT Systems because a software fault prevents the tube current modulation feature from working.

    Product
    AIRO Mobile CT System Model # MobiCT-32
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2755-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 11,488 temperature sensor Foley catheters because defective sensors may display lower body temperatures than actual.

    Product
    Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2776-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors

    Degania Silicone, Ltd. is recalling 100 units of temperature sensing Foley catheters because defective sensors may display lower body temperatures than actual.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101080MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3191-2018·2018-09-26

    Swissray Medical Recalls ddR Formula B X-ray Systems for Bucky Movement Risk

    Swissray Medical is recalling 27 ddR Formula B X-ray systems because the bucky component may move unexpectedly, posing a risk of injury to patients.

    Product
    ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2780-2018·2018-09-26

    Degania Silicone Recalls Thermistor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling Thermistor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Thermistor Foley catheter, nonsterile, Catalogue Number 102201101463MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3010-2018·2018-09-26

    Ventana anti-Helicobacter Pylori Reagent Recall Due to Dispenser Leaks

    Ventana Medical Systems is recalling anti-Helicobacter Pylori reagents because leaking dispensers may cause false negative test results.

    Product
    VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2775-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 500 sterile Foley catheters with defective temperature sensors that may display inaccurate readings.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2784-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors

    Degania Silicone, Ltd. is recalling 1,000 temperature sensing Foley catheters because defective sensors may display lower body temperatures than actual.

    Product
    Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2773-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 500 temperature-sensing Foley catheters because defective sensors may display lower body temperatures than actual.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101480MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3000-2018·2018-09-26

    Ventana OptiView Amplification Kit Recalled for Leaking Dispensers

    Ventana Medical Systems is recalling OptiView Amplification Kits due to leaking dispensers that may cause false negative IHC results.

    Product
    OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2757-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensor Catheters Due to Defective Sensors

    Degania Silicone, Ltd. is recalling 1,588 Temperature Sensor Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2777-2018·2018-09-26

    Degania Silicone Recalls Thermistor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 2,784 Thermistor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2764-2018·2018-09-26

    Degania Foley Catheters Recalled for Defective Temperature Sensors

    Degania Silicone is recalling 47,520 Foley catheters with temperature sensors because defective sensors may display lower body temperatures than actual.

    Product
    Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2760-2018·2018-09-26

    Degania Temperature Sensor Catheters Recalled for Defective Sensors

    Degania Silicone is recalling 16,350 temperature sensor catheters because defective sensors may display lower body temperatures than actual.

    Product
    Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3183-2018·2018-09-26

    Med-Mizer Recalls PR1000 Pivot Rehab Beds Due to Cable Pinching Risk

    Med-Mizer is recalling 230 PR1000 Pivot Rehab Beds because wires may become pinched during extreme left pivoting, requiring patient transfer until repaired.

    Product
    PR1000 Pivot Rehab Bed AC powered adjustable bed.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-2759-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensor Catheters Due to Defective Sensors

    Degania Silicone is recalling 1,028 temperature sensor catheters because defective sensors may display lower body temperatures than actual.

    Product
    Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3181-2018·2018-09-26

    Stryker Recalls IsoFlex LAL Support Surfaces Due to Fire Barrier Defect

    Stryker is recalling 243 IsoFlex LAL support surfaces because they were assembled with a non-conforming fire barrier. The units were distributed in five US states.

    Product
    IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the prevention and treatment of all pressure injuries (including stages 1,2,3,4, unstageable injury, and deep tissue injury) and is recommended to be implemented in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2996-2018·2018-09-26

    Ventana OptiView DAB IHC Detection Kit Recalled for Leaking Dispensers

    Ventana Medical Systems is recalling OptiView DAB IHC Detection Kits because leaking dispensers may cause false negative test results.

    Product
    OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2758-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 475 Temperature Sensor Foley Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder…
    Category
    Medical Device
    Distribution
    Distributed nationwide