Degania Silicone, Ltd.

Complete recall history across all FDA and CPSC categories — 43 total recalls

Degania Silicone, Ltd. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (43)

FDA medical device enforcement actions by Degania Silicone, Ltd.

Date Product Reason Class
Dec 2, 2019 Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number:... Temperature deviation did not meet release specifications Class II
Jun 28, 2019 Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An intro... 15FR and 19FR round fluted drain channel drain may break during use (mostly d... Class II
Jun 28, 2019 Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Healt... 15FR and 19FR round fluted drain channel drain may break during use (mostly d... Class II
Jun 28, 2019 Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Healt... 15FR and 19FR round fluted drain channel drain may break during use (mostly d... Class II
Jun 28, 2019 Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar ... 15FR and 19FR round fluted drain channel drain may break during use (mostly d... Class II
Jun 28, 2019 Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN:... 15FR and 19FR round fluted drain channel drain may break during use (mostly d... Class II
Jun 28, 2019 Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 ... 15FR and 19FR round fluted drain channel drain may break during use (mostly d... Class II
Jun 28, 2019 Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar C... 15FR and 19FR round fluted drain channel drain may break during use (mostly d... Class II
Jun 28, 2019 Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar C... 15FR and 19FR round fluted drain channel drain may break during use (mostly d... Class II
Jun 21, 2018 Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 1... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Foley Temperature Sensor Catheter 10FR, Catalogue Number 102201101080JP Pr... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Thermistor Foley catheter, nonsterile, Catalogue Number 102201101463MD Pro... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 1... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 1... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Foley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP Pro... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Temperature sensing catheter 14FR, Catalogue Number 102203101463DO Product... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Pr... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD Pro... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product ... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product ... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product ... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Pro... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product U... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD Produ... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Pro... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product ... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP Pr... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 1... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Pr... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 1022011008... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Temperature sensing catheter 18FR, Catalogue Number 102203101863DO Product... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product ... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB Pr... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 1... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Jun 21, 2018 Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101... The catheters are suspected to contain defective sensors; if used, defective ... Class II
Oct 3, 2017 Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Num... Sterile pouches are missing labels on them. The boxes themselves are properly... Class III
Jan 31, 2017 Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Ster... Product sterility compromised due to breach of sterile barrier Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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