Browse Device Recalls

14 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 14 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 14 FDA device recalls.

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DateProductReasonClassFirm
Sep 20, 2013 MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended f... The root cause investigation showed that the under-volume hazard can occur when the unit has bee... Class II Medrad Inc dba Bayer R&I
Apr 15, 2013 DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs... The firm is recalling these power cables due to a latent design reliability issue and the potenti... Class II Medrad Inc
Nov 5, 2012 MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardia... The seal between the white polyethylene and the clear plastic may be missing on the Hand Controll... Class II Medrad Inc
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.