Browse Device Recalls
116 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 116 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 116 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 8, 2018 | BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage... | Medtronic has been unable to develop a cleaning protocol to satisfy current industry concerns and... | Class II | Medtronic Perfusion Systems |
| Jan 16, 2018 | Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter... | Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alo... | Class II | Medtronic Perfusion Systems |
| Jan 16, 2018 | Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 ... | Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alo... | Class II | Medtronic Perfusion Systems |
| Jan 3, 2018 | Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal c... | Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lac... | Class II | Medtronic Perfusion Systems |
| Jun 22, 2017 | DLP Extension Line Adapters 20 in length Used to extend cardioplegia line du... | Identification of small pinholes in a single packaging configuration of sterile pouches. A total... | Class II | Medtronic Perfusion Systems |
| Jun 22, 2017 | DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in... | Identification of small pinholes in a single packaging configuration of sterile pouches. A total... | Class II | Medtronic Perfusion Systems |
| Jun 22, 2017 | DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure m... | Identification of small pinholes in a single packaging configuration of sterile pouches. A total... | Class II | Medtronic Perfusion Systems |
| Jun 22, 2017 | DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia altern... | Identification of small pinholes in a single packaging configuration of sterile pouches. A total... | Class II | Medtronic Perfusion Systems |
| Jun 22, 2017 | DLP Pressure Disposable Pressure Display Sets Extends the pressure line in o... | Identification of small pinholes in a single packaging configuration of sterile pouches. A total... | Class II | Medtronic Perfusion Systems |
| Feb 4, 2016 | Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascu... | Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tub... | Class III | Medtronic Perfusion Systems |
| Oct 28, 2015 | Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Ste... | This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactu... | Class II | Medtronic Perfusion Systems |
| Aug 18, 2015 | MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist ... | Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is be... | Class II | Medtronic Perfusion Systems |
| Aug 18, 2015 | MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators... | Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is be... | Class II | Medtronic Perfusion Systems |
| Jul 24, 2015 | Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to... | EOPA Arterial Cannula Devices in this lot were shipped without the guidewire. | Class II | Medtronic Perfusion Systems |
| Jun 12, 2015 | Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and D... | Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports ... | Class II | Medtronic Perfusion Systems |
| Oct 31, 2014 | The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bi... | Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenat... | Class II | Medtronic Perfusion Systems |
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.