Browse Device Recalls
1,730 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,730 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 1,730 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 30, 2014 | Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78... | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Jan 30, 2014 | Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB... | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Jan 9, 2014 | Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obtura... | Medtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model 7305 used with th... | Class II | Medtronic Cardiovascular Surgery-the Heart Valv... |
| Jan 6, 2014 | Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A,... | Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2... | Class II | Medtronic Sofamor Danek USA Inc |
| Jan 3, 2014 | SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Dane... | The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not al... | Class II | Medtronic Sofamor Danek USA Inc |
| Nov 18, 2013 | CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-... | Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the St... | Class II | Medtronic Neurosurgery |
| Nov 18, 2013 | Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata ... | Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the St... | Class II | Medtronic Neurosurgery |
| Nov 18, 2013 | Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0... | Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the St... | Class II | Medtronic Neurosurgery |
| Nov 12, 2013 | Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number:... | The internal protection circuitry on the electrosurgical output that prevents a patient from expo... | Class II | Medtronic Advanced Energy, LLC |
| 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 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 | 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 | 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 | 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 | 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 | 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 | 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 7, 2013 | Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Sten... | A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Co... | Class II | Medtronic Vascular, Inc. |
| Sep 30, 2013 | Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, mode... | Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulat... | Class II | Medtronic Neuromodulation |
| Sep 30, 2013 | Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program R... | Medtronic notified customers regarding over stimulation or stimulation in the wrong area related ... | Class II | Medtronic Neuromodulation |
| Sep 30, 2013 | Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-pr... | Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulat... | Class II | Medtronic Neuromodulation |
| Sep 30, 2013 | Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-pr... | Medtronic notified customers regarding over stimulation or stimulation in the wrong area related ... | Class II | Medtronic Neuromodulation |
| Sep 16, 2013 | NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; M... | Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the ... | Class II | Medtronic Vascular, Inc. |
| Aug 23, 2013 | Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The e... | One lot of the product was assembled using the Cam Head version of the same prosthesis instead of... | Class II | Medtronic Xomed, Inc. |
| Aug 12, 2013 | T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile ... | One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8... | Class II | Medtronic Sofamor Danek USA Inc |
| Jul 25, 2013 | Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 a... | Review of on-system electronic product labeling and Instructions for comply with applicable Use i... | Class II | Medtronic Navigation, Inc. |
| Jul 17, 2013 | Medtronic Custom Perfusion System with Trillium BioSurface (a polymer contain... | Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suc... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Jul 17, 2013 | Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1... | Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suc... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Jul 17, 2013 | Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numb... | Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suc... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Jul 15, 2013 | StealthStation S7 Framelink Software version 5.4. Aid for locating anatom... | Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5... | Class II | Medtronic Navigation, Inc. |
| Jul 9, 2013 | Tray Surgical, ENT (various instrument trays) Used for stot age and transp... | The firm will recall and replace the identified instrument trays in the field, with trays that ha... | Class II | Medtronic Xomed, Inc. |
| Jul 8, 2013 | Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the intr... | Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter ... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Jul 3, 2013 | Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332... | Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and... | Class II | Medtronic MiniMed |
| Jun 28, 2013 | Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated f... | Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer cart... | Class II | Medtronic Neurosurgery |
| Jun 14, 2013 | Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized ... | Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because ... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Jun 12, 2013 | Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, ... | Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. ... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Jun 7, 2013 | Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and... | Medtronic recently identified an issue with a subset of Consulta¿ CRT-P and Syncra¿ CRT-P devices... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Jun 7, 2013 | Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion set... | Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMe... | Class I | Medtronic MiniMed |
| Jun 3, 2013 | Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, ... | Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient m... | Class I | Medtronic Neuromodulation |
| Jun 3, 2013 | Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm c... | The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po... | Class I | Medtronic Neuromodulation |
| Jun 3, 2013 | Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 2... | Medtronic is providing Healthcare Professionals with important safety information and patient man... | Class I | Medtronic Neuromodulation |
| Jun 3, 2013 | Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, ... | Medtronic is providing Healthcare Professionals with important safety information and patient man... | Class I | Medtronic Neuromodulation |
| Jun 3, 2013 | Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Cont... | The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po... | Class I | Medtronic Neuromodulation |
| Jun 3, 2013 | Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 2... | Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient m... | Class I | Medtronic Neuromodulation |
| Jun 3, 2013 | Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: cat... | The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po... | Class I | Medtronic Neuromodulation |
| Jun 3, 2013 | Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segm... | The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po... | Class I | Medtronic Neuromodulation |
| May 28, 2013 | INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA,... | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... | Class II | Medtronic Sofamor Danek USA Inc |
| May 28, 2013 | INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, ... | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... | Class II | Medtronic Sofamor Danek USA Inc |
| May 28, 2013 | INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek US... | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... | Class II | Medtronic Sofamor Danek USA Inc |
| May 28, 2013 | INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, I... | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... | Class II | Medtronic Sofamor Danek USA Inc |
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.