Browse Device Recalls
19 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 19 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 19 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 7, 2016 | MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses ... | Bayer has determined that all current Source Administration Sets (SAS) used with the Medrad Integ... | Class II | Bayer Healthcare |
| Sep 30, 2016 | PET Infusion Pump | The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet ... | Class II | Bayer Healthcare |
| Aug 2, 2016 | Certegra Workstation used in conjunction with Medrad Stellant CT Injection Sy... | CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exh... | Class II | Bayer Healthcare |
| Jun 9, 2016 | Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDR... | Bayer Healthcare is initiating this recall due to complaints that were received from customer sit... | Class II | Bayer Healthcare |
| Nov 30, 2015 | Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDR... | The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tub... | Class II | Bayer Healthcare |
| Aug 4, 2015 | Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilize... | Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional Ne... | Class II | Bayer Healthcare |
| Jun 22, 2015 | Contour Next Control Solution for Contour Next Blood Glucose Test System. Li... | If the control solution bottle is not thoroughly shaken prior to use, the control test result may... | Class II | Bayer Healthcare, LLC |
| Aug 26, 2013 | Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/0884261... | Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of li... | Class II | Bayer Healthcare Llc |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump Syst... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for ... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristalti... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion System Standard Administration Kit Perista... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump ... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump Sy... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion System Secondary VSA Set Peristaltic Pump ... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump Syst... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pum... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion System Secondary Administration Kit Perist... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad 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.