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.

27626–27650 of 50462

  • 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 (Food)·F-1966-2018·2018-09-26

    Shearer's White Corn Tortilla Chips Recalled for Metal Contamination

    Shearer's Foods is recalling specific lots of white corn tortilla chips due to possible metal contamination. The products were distributed in 17 US states and Canada.

    Product
    White Corn Tortilla Chips packaged under the following brand names and sizes: 1. Shearer's White Restaurant Style Bulk, 12 ct. 16 oz., #203540212; 2. Shearer's White Round Tortilla Bulk, 12 ct. 16 oz., #210230212; 3. Shurfine Tortilla Chips, Net Wt. 30 oz (1 lb 14…
    Category
    Food
    Distribution
    17 states
  • 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-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
  • HighCPSC·18233·2018-09-26

    CFMOTO Recalls CFORCE ATVs Due to Fuel Hose Fire Hazard

    CFMOTO is recalling about 5,300 CFORCE all-terrain vehicles because a fuel hose can crack and leak, posing a fire hazard. No injuries have been reported.

    Product
    CFORCE all-terrain off-highway vehicles (ATVs)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • 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
  • HighFDA (Devices)·Z-2785-2018·2018-09-26

    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 the patient's actual temperature.

    Product
    Temperature sensing catheter 16FR, Catalogue Number 102201101663NU 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-3203-2018·2018-09-26

    Coviden Recalls Defective Temperature Sensing Foley Catheters

    Coviden is recalling specific sterile Foley catheter trays because the temperature sensors 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 P4P16XTSD
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-2770-2018·2018-09-26

    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 12FR, Catalogue Number 102201101280JP 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-2778-2018·2018-09-26

    Degania Silicone Recalls Thermistor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 14,326 Thermistor Foley catheters because defective sensors may display inaccurate, lower body temperature readings.

    Product
    Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD 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-2761-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensor Catheters Due to Defective Sensors

    Degania Silicone is recalling 16,133 temperature sensor catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI 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-2766-2018·2018-09-26

    Degania Foley Catheters Recalled Due to Defective Temperature Sensors

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

    Product
    Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY 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
  • HighNHTSA·18V674000·2018-09-26

    BMW Recalls 2013-2015 760Li Vehicles for Engine Stall Risk

    BMW is recalling 2013-2015 760Li vehicles because incompatible software in the Engine Control Unit may cause the engine to stall, increasing crash risk.

    Product
    BMW — BMW 760LI
    Category
    Vehicle
    Distribution
    Distributed nationwide