The Recall Desk

Manufacturer

Degania Silicone, Ltd.

43 recalls in our database name Degania Silicone, Ltd. as the manufacturing or recalling firm.

What the numbers show

Total
43
Critical
0
Severe
8
Most recent
2020-01-22

Of the 43 recalls from Degania Silicone, Ltd. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (19%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 43

  • ModerateFDA (Devices)·Z-0809-2020·2020-01-22

    Medline Thermistor Foley Catheter Recalled for Temperature Deviation

    Degania Silicone is recalling 2,080 units of Medline Thermistor Foley Catheters because temperature readings did not meet release specifications.

    Product
    Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2265-2019·2019-08-21

    Degania Silicone Recalls Jackson-Pratt Channel Drains Due to Breakage Risk

    Degania Silicone is recalling 2,160 units of Cardinal Health Jackson-Pratt Channel Drains because they may break during use, potentially requiring additional surgery.

    Product
    Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than bloo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2263-2019·2019-08-21

    Cardinal Health Jackson-Pratt Channel Drain Recall for Breakage Risk

    Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drains because they may break during use, requiring additional surgery.

    Product
    Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN JP-2190 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, dr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2262-2019·2019-08-21

    Degania Silicone Jackson-Pratt Channel Drain Recall for Breakage Risk

    Degania Silicone is recalling 6,080 units of Cardinal Health Jackson-Pratt Channel Drains because they may break during use, requiring additional surgery.

    Product
    Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2264-2019·2019-08-21

    Degania Silicone Recalls Jackson-Pratt Channel Drains Due to Breakage Risk

    Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drains because they may break during use, requiring additional surgery to remove the broken end.

    Product
    Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2266-2019·2019-08-21

    Medline Silicone Drain Recalled for Risk of Breaking During Use

    Degania Silicone is recalling 200 units of Medline Silicone Drains because they may break during use, requiring additional surgery to remove the broken end.

    Product
    Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2260-2019·2019-08-21

    Degania Silicone Jackson-Pratt Channel Drain Recall for Breakage Risk

    Degania Silicone is recalling 640 units of Jackson-Pratt Channel Drains because they may break during use or removal, requiring additional surgery.

    Product
    Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2261-2019·2019-08-21

    Cardinal Health Jackson-Pratt Channel Drain Recall for Breakage Risk

    Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drains because they may break during use or removal, requiring additional surgery.

    Product
    Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2267-2019·2019-08-21

    Smith & Nephew Wound Drain Recall Due to Breakage Risk

    Smith & Nephew is recalling 15FR and 19FR channel wound drains because they may break during use or removal, requiring additional surgery.

    Product
    Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain flu
    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 a
    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 fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2779-2018·2018-09-26

    Degania Silicone Recalls Thermistor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 330 Thermistor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD 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-2763-2018·2018-09-26

    Degania Silicone Recalls Foley Catheters with Defective Temperature Sensors

    Degania Silicone is recalling 4,332 Foley catheters with temperature sensors because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 102201100880TY 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 ur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 bladd
    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 bladd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2756-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 500 units of temperature sensor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB 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 blad
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2765-2018·2018-09-26

    Degania Silicone Recalls Foley Catheters with Defective Temperature Sensors

    Degania Silicone is recalling 89,122 Foley catheters with temperature sensors because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY 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 u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 blad
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 a
    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 fr
    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 an
    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 bladd
    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 an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 an
    Category
    Medical Device
    Distribution
    Distributed nationwide