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Recall archive

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

444 recalls · page 19 of 19

Medical devices

Reported Apr 10, 2013

Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to…

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

Medtronic Neuromodulation

Matched: Brand · Product · Product details · Reason for recallMedtronic has found through device testing that if the optional footswitch is not connected to the Model 8930 RF generator during use, an…

FDA (openFDA device enforcement)

Medical devices

Reported Apr 3, 2013

Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement…

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

Medtronic Inc. Cardiac Rhythm Disease Management

Matched: Brand · Product · Product details · Reason for recallMedtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE…

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Mar 20, 2013

Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile

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

Medtronic Navigation, Inc.

Matched: Brand · Product · Product detailsPotential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction

FDA (openFDA device enforcement)

Medical devices

Reported Mar 13, 2013

Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers:…

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

Medtronic Inc. Cardiac Rhythm Disease Management

Matched: Brand · Product · Product detailsPotential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula.

FDA (openFDA device enforcement)

Medical devices

Reported Jan 9, 2013

Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact…

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

Medtronic Inc. Cardiac Rhythm Disease Management

Matched: Brand · Product · Product details · Reason for recallMedtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain…

FDA (openFDA device enforcement)

Medical devices

Reported Dec 26, 2012

Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in:…

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

Medtronic Neuromodulation

Matched: Brand · Product · Product details · Reason for recallMedtronic has identified 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086), which may contain a damaged winged connector boot.…

FDA (openFDA device enforcement)

Medical devices

Reported Dec 19, 2012

SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion…

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

Medtronic Neuromodulation

Matched: Brand · Reason for recallMedtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of…

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Dec 5, 2012

The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated…

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

Medtronic Navigation, Inc.

Matched: Brand · Product details · Reason for recallMedtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation System due to a defect related to the internal threading…

FDA (openFDA device enforcement)

Medical devices

Reported Oct 17, 2012

ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic

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

Medtronic Sofamor Danek USA Inc.

Matched: Brand · Product · Product detailsLines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure…

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Sep 19, 2012

Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response)…

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

Medtronic Xomed, Inc.

Matched: Brand · Product · Product details · Reason for recallIn January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions…

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 29, 2012

Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120,…

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

Medtronic Navigation, Inc.

Matched: Brand · Product · Product detailsA fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn.

FDA (openFDA device enforcement)

Medical devices

Reported Jun 27, 2012

Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120.…

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

Medtronic Navigation, Inc.

Matched: Brand · Product · Product detailsSoftware Version 3.1.1 does not meet navigational accuracy.

FDA (openFDA device enforcement)

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