Browse Device Recalls
43 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 43 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 43 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Degania Silicone, Ltd. |
| 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 during removal) in co... | Class II | Degania Silicone, Ltd. |
| 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 during removal) in co... | Class II | Degania Silicone, Ltd. |
| 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 during removal) in co... | Class II | Degania Silicone, Ltd. |
| 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 during removal) in co... | Class II | Degania Silicone, Ltd. |
| 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 during removal) in co... | Class II | Degania Silicone, Ltd. |
| 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 during removal) in co... | Class II | Degania Silicone, Ltd. |
| 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 during removal) in co... | Class II | Degania Silicone, Ltd. |
| 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 during removal) in co... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 1... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Foley Temperature Sensor Catheter 10FR, Catalogue Number 102201101080JP Pr... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101463MD Pro... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 1... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 1... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Foley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP Pro... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature sensing catheter 14FR, Catalogue Number 102203101463DO Product... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Pr... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD Pro... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product ... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product ... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product ... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Pro... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product U... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD Produ... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Pro... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product ... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP Pr... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 1... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Pr... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 1022011008... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature sensing catheter 18FR, Catalogue Number 102203101863DO Product... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product ... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB Pr... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 1... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| 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 labeled. The issue ... | Class III | Degania Silicone, Ltd. |
| 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 | Degania Silicone, Ltd. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.