The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

27601–27625 of 50462

  • HighFDA (Devices)·Z-3206-2018·2018-09-26

    Coviden Temperature Sensing Foley Catheters Recalled for Inaccurate Readings

    Coviden is recalling temperature sensing Foley catheters because they may display lower body temperature readings than the patient's actual temperature.

    Product
    400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-2783-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 2,461 temperature sensing Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature sensing catheter 18FR, Catalogue Number 102203101863DO 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-2774-2018·2018-09-26

    Degania Silicone Foley Catheters Recalled for Defective Temperature Sensors

    Degania Silicone is recalling 500 units of temperature-sensing Foley catheters because defective sensors may display inaccurate, lower body temperature readings.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101880MD 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-2772-2018·2018-09-26

    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 100% Silicone Foley Catheter, sterile, Catalogue Number 102201100880MD 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-3210-2018·2018-09-26

    Medline Recalls Endoscopic Cleaning Brushes Due to Detachment Risk

    Medline Industries is recalling single-use endoscopic cleaning brushes because they may detach during cleaning, potentially leaving parts inside the scope.

    Product
    Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2782-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 34,627 temperature sensing Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature sensing catheter 16FR, Catalogue Number 102203101663DO 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-2771-2018·2018-09-26

    Degania Foley Temperature Sensor Catheters Recalled for Defective Sensors

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

    Product
    Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP 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-2768-2018·2018-09-26

    Degania Foley Temperature Sensor Catheters Recalled for Defective Sensors

    Degania Silicone is recalling 250 Foley Temperature Sensor Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Foley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP 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-3211-2018·2018-09-26

    Accuray Recalls CyberKnife Calibration Film Due to Dimensional Inaccuracy

    Accuray is recalling 259 units of Ashland Box Film Ball Cube II calibration film because manufacturing defects may cause up to 0.5 mm of positional inaccuracy in CyberKnife systems.

    Product
    Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2762-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 1,025 Temperature Sensor Catheters because defective sensors may display lower body temperatures than actual patient readings.

    Product
    Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI 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-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 (Food)·F-1969-2018·2018-09-26

    CedarLane Organic Couscous Salad Recalled for Undeclared Wheat Allergen

    CedarLane Organic Couscous, Veggies & Chickpeas with Citrus Dressing is being recalled because it is labeled gluten-free but contains undeclared wheat.

    Product
    CedarLane Organic Salads; Couscous, Veggies & Chickpeas with Citrus Dressing. NET WT 9 oz. -Gluten Free -Vegetarian Perishable, Keep Refrigerated. UPC: 38794 99904 Manufactured and Distributed by: CedarLane Foods, Carson, CA 90746
    Category
    Food
    Distribution
    9 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
  • HighNHTSA·18V671000·2018-09-26

    Volkswagen Recalls 2019 Jetta Vehicles Due to Misaligned Headlights

    Volkswagen is recalling 2019 Jetta vehicles with LED headlights because the passenger-side light may be misaligned, reducing visibility and increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN JETTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V676000·2018-09-26

    Midwest Fire Recalls All-Poly Series Emergency Vehicles Due to Software Defect

    Midwest Fire is recalling 2014-2019 All-Poly Series emergency vehicles because touchscreen software may cause accessories to turn on or off unexpectedly, increasing crash risk.

    Product
    MIDWEST FIRE — MIDWEST FIRE ALL-POLY SERIES
    Category
    Vehicle
    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 (Food)·F-1967-2018·2018-09-26

    Shearers Foods Recalls Yellow Corn Tortilla Chips Due to Metal Contamination

    Shearers Foods is recalling specific lots of yellow corn tortilla chips sold under multiple brands due to possible metal contamination.

    Product
    Yellow Corn Tortilla Chips packaged under the following brand names and sizes: 1. Shearer's Restaurant Rounds Tortilla Chips, Net Wt. 3 oz. (85g), UPC 37578-61920; 2. Uno Grande Yellow Round Tortilla Chips, 6 ct 16 oz, #903040112; 3. Wendy's, Net Wt. 1.5 oz.…
    Category
    Food
    Distribution
    17 states