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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
Feb 19, 2016 CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospec... Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink i... Class II Medtronic MiniMed Inc.
Sep 25, 2015 MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed... The pump drive motors may experience a malfunction which would result in a pump error message ala... Class II Medtronic MiniMed Inc.
Sep 25, 2015 MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 T... The pump drive motors may experience a malfunction which would result in a pump error message ala... Class II Medtronic MiniMed Inc.
Jul 22, 2015 Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or p... Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System becaus... Class II Medtronic MiniMed Inc.
Jun 19, 2015 MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), ... Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain ... Class II Medtronic MiniMed Inc.
Nov 10, 2014 CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software... The firm is informing customers of a software error that might result in an inaccurate display of... Class III Medtronic MiniMed Inc.
Nov 4, 2014 Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Si... Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T... Class II Medtronic MiniMed Inc.
Jul 21, 2014 Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Us... Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue t... Class II Medtronic MiniMed Inc.
Jun 16, 2014 Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D Medtronic MiniMed is recalling the Implantable Insulin Pump because there have been reports of a ... Class II Medtronic MiniMed Inc.
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.

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.