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 |
|---|---|---|---|---|
| Mar 10, 2014 | SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installe... | The System may go into a controlled failed state if a series of parameters on the user interface ... | Class I | Del Mar Reynolds Medical, Ltd. |
| Mar 5, 2014 | Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Par... | The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted an... | Class I | Draeger Medical Systems, Inc. |
| Mar 4, 2014 | HeartMate II System Controller Product Usage: HeartMate II is a mechanica... | Discovery of serious injuries and deaths associated with the process of changing from a primary S... | Class I | Thoratec Corporation |
| Mar 4, 2014 | HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMat... | Discovery of serious injuries and deaths associated with the process of changing from a primary S... | Class I | Thoratec Corporation |
| Mar 4, 2014 | Heart Mate II Pocket Controllers removed from packaging Product Usage: ... | Discovery of serious injuries and deaths associated with the process of changing from a primary S... | Class I | Thoratec Corporation |
| Mar 4, 2014 | HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) w... | Discovery of serious injuries and deaths associated with the process of changing from a primary S... | Class I | Thoratec Corporation |
| Feb 19, 2014 | FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. S... | Abbott Diabetes Care has identified through internal testing and investigation that all non-appli... | Class I | Abbott Diabetes Care, Inc. |
| Feb 19, 2014 | FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Dis... | Abbott Diabetes Care has identified through internal testing and investigation that all non-appli... | Class I | Abbott Diabetes Care, Inc. |
| Feb 18, 2014 | GemStar Docking Station, used with GemStar infusion pump, in combination with... | There are two situations that may occur when using the GemStar Docking Station, List Number 13075... | Class I | Hospira Inc. |
| Feb 11, 2014 | Trilogy Ventilators The Respironics Trilogy 100 system provides continuous o... | Internal testing revealed a potentially defective component on the power management board that co... | Class I | Phillips Respironics, Inc. |
| Feb 7, 2014 | SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product U... | Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volum... | Class I | Baxter Healthcare Corp. |
| Feb 7, 2014 | Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care... | The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Crit... | Class I | Draeger Medical Systems, Inc. |
| Feb 3, 2014 | The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is... | The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one... | Class I | Hospira Inc. |
| Feb 3, 2014 | The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is... | The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one... | Class I | Hospira Inc. |
| Jan 31, 2014 | Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T1028... | Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Imp... | Class I | Greatbatch Medical |
| Jan 10, 2014 | T:slim Insulin Delivery System Insulin Infusion Pump | Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for... | Class I | Tandem Diabetes Care Inc |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Dec 16, 2013 | Puritan Bennett 840 ventilator systems software part number 4-070212-85, revi... | Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator syst... | Class I | Covidien |
| Dec 6, 2013 | Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catal... | The housing to the Pump's driveline connector became partially or fully separated from the front ... | Class I | HeartWare Inc |
| Dec 5, 2013 | Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto... | CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will... | Class I | CareFusion 303, Inc. |
| Nov 25, 2013 | Viscocel and Viscocel Plus. These products are intraocular fluid devices c... | CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in ... | Class I | C.L.R. Medicals International, Inc. |
| Nov 18, 2013 | FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 co... | Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low bl... | Class I | Abbott Diabetes Care, Inc. |
| Nov 18, 2013 | FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. ... | Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low bl... | Class I | Abbott Diabetes Care, Inc. |
| Oct 31, 2013 | Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions incl... | Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Enc... | Class I | Hospira Inc. |
| Oct 31, 2013 | Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infus... | Broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly... | Class I | Hospira Inc. |
| Oct 28, 2013 | Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: ... | Promotional materials for non-medical water filtration products were determined to promote claims... | Class I | Nephros Inc |
| Oct 28, 2013 | Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ... | Promotional materials for non-medical water filtration products were determined to promote claims... | Class I | Nephros Inc |
| Oct 28, 2013 | 1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros ... | Promotional materials for non-medical water filtration products were determined to promote claims... | Class I | Nephros Inc |
| Oct 21, 2013 | THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are... | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | Class I | Medtronic Vascular |
| Oct 21, 2013 | COUGAR¿ Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT19... | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | Class I | Medtronic Vascular |
| Oct 21, 2013 | ProVia¿ CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PR... | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Med... | Class I | Medtronic Vascular |
| Oct 21, 2013 | ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZR... | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | Class I | Medtronic Vascular |
| Oct 21, 2013 | ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Att... | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | Class I | Medtronic Vascular |
| Oct 21, 2013 | THUNDER¿ Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, T... | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | Class I | Medtronic Vascular |
| Oct 21, 2013 | Zinger¿ Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS... | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | Class I | Medtronic Vascular |
| Oct 21, 2013 | Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS19... | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | Class I | Medtronic Vascular |
| Oct 17, 2013 | CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation,... | Spacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part Number 050-0659-00 a... | Class I | Del Mar Reynolds Medical, 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.