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Medtronic Xomed, Inc.

Medtronic Xomed, Inc. Recalls

All product recalls associated with Medtronic Xomed, Inc..

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Recall Summary

Total Recalls

606

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 321–340 of 606 recalls

Medtronic Xomed, Inc.: Lamicel 10PK 10MM INTL

Routine sterilization dose does not meet the required Sterility Assurance Level.

FDANov 13, 2019IN• Medtronic Xomed, Inc.

Medtronic Xomed, Inc.: Lamicel 20PK 3MM INTL Cervical dilator

Routine sterilization dose does not meet the required Sterility Assurance Level.

FDANov 13, 2019IN• Medtronic Xomed, Inc.

Medtronic Navigation, Inc.: Biopsy Needle FPU Kit, Product # 9731754, UDI: 006431693...

The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery.

FDAOct 30, 2019AL, AK, AZ +47 more• Medtronic Navigation, Inc.

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Medtronic Navigation, Inc.: Passive Biopsy Needle Kit, UDI: 00643169030121 and 0064...

FDAOct 30, 2019AL, AK, AZ +47 more• Medtronic Navigation, Inc.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Programmers & Remote Monitoring Software Apps: 2090 Care...

There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality.

FDAOct 3, 2019Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Navigation, Inc.: NavLock Tracker *** Rx Only

Product was incorrectly assembled which could affect navigation accuracy of the device.

FDAAug 28, 2019NY• Medtronic Navigation, Inc.

Medtronic Navigation, Inc.: Medtronic Nexframe Stereotactic System and StealthStation...

Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging system (also known as a fiducial-less procedure). Minor patient movement may not be initially detected by the user or the software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention (including revision of the lead placement and subsequent imaging).

FDAAug 9, 2019Nationwide• Medtronic Navigation, Inc.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac...

Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.

FDAAug 6, 2019Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic Micra MC1VR01, Single chamber transcatheter pac...

FDAAug 6, 2019Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Navigation, Inc.: Visualase Cooled Laser Applicator System Tubing Set kits ...

The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector assembly, incorrect drip-chamber assembly, and/or excessive adhesive causing tubing occlusion, all of which could result in disruption or prevention of saline flow.

FDAJul 8, 2019AL, AZ, AR +34 more• Medtronic Navigation, Inc.

Medtronic Inc: Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Us...

Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.

FDAMay 21, 2019Nationwide• Medtronic Inc

Medtronic Inc: Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Pr...

FDAMay 21, 2019Nationwide• Medtronic Inc

Medtronic Inc.: Guardian Connect App CSS7200 iOS and Guardian Connect Tr...

Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or 12,2 are likely to experience a shortened transmitter battery life (approximately 4-5 days instead of the normal 7 days or more) after a full charge.

FDAMay 20, 2019Nationwide• Medtronic Inc.

Medtronic Navigation, Inc.-Littleton: Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX...

The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the system. If a charger board is not functioning properly, the batteries will not receive a full recharge of the potential capacity and results in the inability of the system to take X-rays, open the gantry, and move the system from one place to another, which may affect the ability to continue use within the operating room until the charger board and/or the batteries are replaced

FDAMay 1, 2019Nationwide• Medtronic Navigation, Inc.-Littleton

Medtronic Sofamor Danek USA Inc: POWEREASE Instruments Set Screw Breakoff Instrument, REF ...

The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.

Class IIModerate

FDADec 3, 2014AR, CA, FL +13 more• Medtronic Sofamor Danek USA Inc

Medtronic MiniMed Inc.: CareLink Pro Medtronic CareLink Pro MMT-7335 is a person...

The firm is informing customers of a software error that might result in an inaccurate display of the Temp Basal time and duration in CareLink Clinical reports with data uploaded from the MiniMed 620G or 640G insulin pump.

Class IIILow

FDANov 10, 2014Nationwide• Medtronic MiniMed Inc.

Medtronic MiniMed Inc.: Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusi...

Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets. Detachment causes interrupted insulin delivery and the pump will not alarm to notify your patient. This can lead to hyperglycemia, and diabetic ketoacidosis (DKA).

Class IIModerate

FDANov 4, 2014Nationwide• Medtronic MiniMed Inc.

Medtronic MiniMed Inc.: Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CS...

Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue that has the potential to compromise the water resistance of the affected Guardian monitors.

Class IIModerate

FDAJul 21, 2014Nationwide• Medtronic MiniMed Inc.

Medtronic Inc: IDEAL MAXPAC TOTAL SYSTEM (USA) , Sterile and Nonpyrogeni...

Medtronic has identified a small number of Autotransfusion One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates (UBD) on the outer kit package label. The UBD on the outer label of the kit/pack does not accurately reflect the UBD of the components within the kit/Pack. For affected product, the outer label lists a date which may be later than the USB of the components inclu

FDADec 14, 2009CA, CO• Medtronic Inc

Medtronic Inc: Medtronic HMS PLUS, Hemostasis Management System, Model ...

Recently the US Food and Drug Administration (FDA) issued an alert, communicating a change in the United States Pharmacopeia (USP) monograph for heparin, introducing a new USP reference standard that will in effect, change potency, and harmonize the USP unit dose with the WHO International Standard (IU) unit dose. Users of the Medtronic Hemostasis Management System (HMS Plus) must be aware o

FDADec 14, 2009Nationwide• Medtronic Inc