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.

26–43 of 43

HighFDA (Devices)·Z-2754-2018·2018-09-26
Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 153 temperature sensor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB 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-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 a
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 u
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 u
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 bladd
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 blad
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 a
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 an
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 and
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 fr
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 bladd
Category
Medical Device
Distribution
Distributed nationwide
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 a
Category
Medical Device
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 an
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2769-2018·2018-09-26
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 actual.
Product
Foley Temperature Sensor Catheter 10FR, Catalogue Number 102201101080JP 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-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 fr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2767-2018·2018-09-26
Foley Catheter with Temperature Sensor Recalled for Defective Sensors
Degania Silicone is recalling 12,532 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 18FR, Catalogue Number 102201101880TY 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
ModerateFDA (Devices)·Z-0899-2018·2018-03-14
Medical Device Recall: Silicone Fluted Round Drain and Connector
Degania Silicone, Ltd. is recalling Silicone Fluted Round Drain 24Fr and Connector units because sterile pouches are missing labels. The boxes are properly labeled, and only lot P1607442 is affected.
Product
Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1233-2017·2017-03-01
Degania Silicone Jackson-Pratt Drain Recalled for Sterility Compromise
Degania Silicone is recalling 3,040 units of Jackson-Pratt Channel Drain Silicone Round because the sterile barrier was breached, compromising sterility.
Product
Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.
Category
Medical Device
Distribution
1 state