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Recall archive

94,355 stored notices, from Jun 20, 2012 to Sep 23, 2026.

40 recalls · page 2 of 2

Medical devices

Reported Nov 29, 2017

Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic Inc.

Matched: Brand · Product · Product details · Reason for recallMedtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

4 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jun 28, 2017

MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic Inc.

Matched: Brand · Product · Product details · Reason for recallMedtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive.

3 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 10, 2017

BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Becton Dickinson & Company

Matched: Product · Product details · Reason for recallPatients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was…

FDA (openFDA device enforcement)

Medical devices

Reported Oct 5, 2016

CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic Inc.

Matched: Brand · Reason for recallMedtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.

FDA (openFDA device enforcement)

Medical devices

Reported Apr 27, 2016

CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic MiniMed Inc.

Matched: Brand · Reason for recallMedtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports were created using the Pacific Standard…

FDA (openFDA device enforcement)

Medical devices

Reported Dec 23, 2015

MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic MiniMed Inc.

Matched: Brand · Product · Product detailsThe pump drive motors may experience a malfunction which would result in a pump error message alarm notifying you that insulin is no longer being…

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Sep 2, 2015

Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic MiniMed Inc.

Matched: Brand · Reason for recallMedtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System because it has a language translation error that impacts…

FDA (openFDA device enforcement)

Medical devices

Reported Aug 5, 2015

MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic MiniMed Inc.

Matched: Brand · Product · Product details · Reason for recallMedtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain scenarios where the set Bolus screen will not…

FDA (openFDA device enforcement)

Medical devices

Reported Mar 11, 2015

CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Medtronic MiniMed Inc.

Matched: Brand · Product · Product details · Reason for recallThe firm is informing customers of a software error that might result in an inaccurate display of the Temp Basal time and duration in CareLink…

FDA (openFDA device enforcement)

Medical devices

Reported Dec 17, 2014

Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic MiniMed Inc.

Matched: Brand · Product · Product details · Reason for recallTubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets. Detachment causes interrupted…

FDA (openFDA device enforcement)

Medical devices

Reported Sep 3, 2014

Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic MiniMed Inc.

Matched: Brand · Product · Product details · Reason for recallMedtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally…

FDA (openFDA device enforcement)

Medical devices

Reported Aug 20, 2014

Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic MiniMed Inc.

Matched: Brand · Product · Product details · Reason for recallMedtronic MiniMed is recalling the Implantable Insulin Pump because there have been reports of a pump malfunction resulting in the disconnection of…

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 14, 2014

Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic Neuromodulation

Matched: Brand · Product · Product detailsSome refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or…

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 28, 2013

Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic MiniMed

Matched: Brand · Product · Product details · Reason for recallMedtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm…

FDA (openFDA device enforcement)

Medical devices

Reported Jul 17, 2013

Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Medtronic MiniMed

Matched: Brand · Product · Product details · Reason for recallMedtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a…

FDA (openFDA device enforcement)

Medical devices

Reported Apr 17, 2013

Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic MiniMed

Matched: Brand · Product · Product details · Reason for recallMedtronic is recalling the Medtronic Paradigm Insulin Pump because the pump's drive support cap may become detached from the pump case and protrude…

FDA (openFDA device enforcement)

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