Browse Device Recalls
1,708 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,708 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 1,708 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 24, 2014 | DISP 9730950 STRL SPHERE, 1 PK INSERT | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | INSTRUMENT TRACKER 9733533XOM ENT 1PK | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | SHUNT KIT 9733605 NON-INVASIVE | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | TUMOR RESECTION KIT 9733607 NON-INVASIVE | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | SPHERES 8801075 5/TRAY 12PK | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | BIT 9733516 2.9mm DRILL STERILE | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | TRAJ GUIDE KIT, 9733065, BIOPSY, EXT | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | SPHERES 8801071 1/TRAY 12PK | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | MOUSE 9732721 STERILE O-ARM 10PK | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | ENT PRGM 9734636 ADD FUSION NAV AxiEM | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | KIT, 9731427, THORACIC TACTILE PROBES | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | TUMOR RES. PACK 9733553 AxiEM S.M. | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | DRAPE 9732722 TUBE STERILE O-ARM 20PK | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | UPGRD PRGM 9734638 ADD AxiEM NAVIGATION | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 4, 2014 | Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtr... | Some refill kits in the affected lots may contain an extension tubing set that is occluded and he... | Class II | Medtronic Neuromodulation |
| Mar 13, 2014 | Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-5... | Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have re... | Class II | Medtronic MiniMed Inc. |
| Mar 3, 2014 | FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm... | Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... | Class II | Medtronic Vascular, Inc. |
| Mar 3, 2014 | FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm,... | Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... | Class II | Medtronic Vascular, Inc. |
| Mar 3, 2014 | FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm,... | Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... | Class II | Medtronic Vascular, Inc. |
| Feb 27, 2014 | Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including t... | Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... | Class II | Medtronic Neuromodulation |
| Feb 27, 2014 | Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), Restore... | Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... | Class II | Medtronic Neuromodulation |
| Feb 27, 2014 | Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC... | Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... | Class II | Medtronic Neuromodulation |
| Feb 26, 2014 | Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-... | This recall provides important new information regarding overinfusion associated with the Medtron... | Class II | Medtronic Neuromodulation |
| Feb 6, 2014 | Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2... | Incorrect master label. | Class III | Medtronic Vascular |
| Jan 30, 2014 | Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 7882... | 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 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-V... | 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 Intersept Custom Tubing Pack which contain Select 3D or Select CAP ... | 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 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-V... | 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 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 |
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.