Browse Device Recalls

2,055 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,055 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 2,055 FDA device recalls in N/A.

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DateProductReasonClassFirm
Jun 27, 2018 Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-bas... The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of... Class II Elekta Instrument AB
Jun 25, 2018 Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMa... Calibration setting was incorrectly entered during manufacturing causing the optical coherence to... Class II Carl Zeiss Meditec AG
Jun 22, 2018 QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING S... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part ... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Numb... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 1... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part ... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part N... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCRE... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 1... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING S... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCRE... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Num... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Numb... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part N... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING S... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING ... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Nu... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
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.

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.