Browse Device Recalls
3,629 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,629 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 3,629 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 18, 2014 | MediChoice¿ Multifunction Electrode Part Number: MC171 OH | Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... | Class I | Covidien LLC |
| Sep 18, 2014 | Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A | Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... | Class I | Covidien LLC |
| Sep 18, 2014 | Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number:... | Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... | Class I | Covidien LLC |
| Sep 17, 2014 | Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Gene... | A failure of a specific component may prevent the ventilators from operating on AC power or trans... | Class I | Respironics California Inc |
| Sep 17, 2014 | Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is ... | The affected lots could have NBF concentrations that are lower or higher than the desired specifi... | Class I | Richard-Allan Scientific Company |
| Sep 17, 2014 | Richard-Allan Scientific Specimen Transportation System. Product Usage: 10... | The affected lots could have NBF concentrations that are lower or higher than the desired specifi... | Class I | Richard-Allan Scientific Company |
| Sep 17, 2014 | Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue... | The affected lots could have NBF concentrations that are lower or higher than the desired specifi... | Class I | Richard-Allan Scientific Company |
| Sep 17, 2014 | Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% ... | The affected lots could have NBF concentrations that are lower or higher than the desired specifi... | Class I | Richard-Allan Scientific Company |
| Sep 17, 2014 | Richard-Allan Scientific Specimen Transportation System. 10% NBF is used t... | The affected lots could have NBF concentrations that are lower or higher than the desired specifi... | Class I | Richard-Allan Scientific Company |
| Sep 17, 2014 | Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10%... | The affected lots could have NBF concentrations that are lower or higher than the desired specifi... | Class I | Richard-Allan Scientific Company |
| Sep 17, 2014 | Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10%... | The affected lots could have NBF concentrations that are lower or higher than the desired specifi... | Class I | Richard-Allan Scientific Company |
| Sep 16, 2014 | Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogen... | Particulate matter found inside the fluid path. | Class I | Baxter Healthcare Corp |
| Sep 16, 2014 | Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, ... | Particulate matter found inside the fluid path. | Class I | Baxter Healthcare Corp |
| Sep 8, 2014 | Hudson RCI¿ Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx ... | The pediatric breathing circuits can crack prior to and during use. | Class I | Teleflex Medical |
| Aug 19, 2014 | STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 C... | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... | Class I | ICU Medical, Inc. |
| Aug 19, 2014 | 83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Contr... | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... | Class I | ICU Medical, Inc. |
| Aug 19, 2014 | STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 C... | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... | Class I | ICU Medical, Inc. |
| Aug 19, 2014 | 98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow C... | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... | Class I | ICU Medical, Inc. |
| Aug 8, 2014 | CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is desig... | CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ven... | Class I | CareFusion 203, Inc. |
| Jul 17, 2014 | CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-... | This remedial action is the result of six product complaints associated with separation of the sn... | Class I | Cook Inc. |
| Jul 7, 2014 | H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit | The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... | Class I | Smiths Medical ASD, Inc. |
| Jul 7, 2014 | H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit | The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... | Class I | Smiths Medical ASD, Inc. |
| Jul 7, 2014 | H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediat... | The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... | Class I | Smiths Medical ASD, Inc. |
| Jul 7, 2014 | H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric... | The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... | Class I | Smiths Medical ASD, Inc. |
| Jul 7, 2014 | 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric ... | The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... | Class I | Smiths Medical ASD, Inc. |
| Jul 7, 2014 | H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediat... | The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... | Class I | Smiths Medical ASD, Inc. |
| Jul 2, 2014 | The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ... | Class I | Hospira Inc. |
| Jul 2, 2014 | The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ... | Class I | Hospira Inc. |
| Jul 2, 2014 | The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ... | Class I | Hospira Inc. |
| Jul 2, 2014 | The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ... | Class I | Hospira Inc. |
| Jul 2, 2014 | The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ... | Class I | Hospira Inc. |
| Jun 11, 2014 | DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DAT... | Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow ... | Class I | GE Healthcare, LLC |
| Jun 9, 2014 | Medtronic Duet External Drainage and Monitoring System, SmartSite Injection S... | Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... | Class I | Medtronic Neurosurgery |
| Jun 9, 2014 | Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... | Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... | Class I | Medtronic Neurosurgery |
| Jun 9, 2014 | Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... | Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... | Class I | Medtronic Neurosurgery |
| Jun 9, 2014 | Medtronic Duet External Drainage and Monitoring System, SmartSite Injection S... | Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... | Class I | Medtronic Neurosurgery |
| Jun 9, 2014 | Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... | Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... | Class I | Medtronic Neurosurgery |
| May 28, 2014 | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... | Class I | Nitinol Devices and Components, Inc. |
| May 28, 2014 | HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180... | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... | Class I | Nitinol Devices and Components, Inc. |
| May 28, 2014 | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... | Class I | Nitinol Devices and Components, Inc. |
| May 28, 2014 | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... | Class I | Nitinol Devices and Components, Inc. |
| May 28, 2014 | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... | Class I | Nitinol Devices and Components, Inc. |
| May 28, 2014 | HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating,... | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... | Class I | Nitinol Devices and Components, Inc. |
| May 28, 2014 | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... | Class I | Nitinol Devices and Components, Inc. |
| May 28, 2014 | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... | Class I | Nitinol Devices and Components, Inc. |
| May 28, 2014 | HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating,... | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... | Class I | Nitinol Devices and Components, Inc. |
| May 28, 2014 | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... | Class I | Nitinol Devices and Components, Inc. |
| May 28, 2014 | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... | Class I | Nitinol Devices and Components, Inc. |
| May 28, 2014 | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... | Class I | Nitinol Devices and Components, Inc. |
| May 28, 2014 | Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are inten... | The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about vi... | Class I | Childrens Medical Ventures |
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.