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Integra LifeSciences Corporation

Integra LifeSciences Corporation Recalls

All product recalls associated with Integra LifeSciences Corporation.

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Recall Summary

Total Recalls

115

Past Year

Class I (Serious)

Most Recent

Dec 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 81–100 of 115 recalls

Integra LifeSciences Corporation: The MAYFIELD¿ Ultra 360 Base Unit for head positioner, on...

Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use.

Class IIModerate

FDADec 19, 2014Nationwide• Integra LifeSciences Corporation

Integra LifeSciences Corp.: Integra Licox Brain Tissue Oxygen Monitoring Integra Lic...

Due to a complaint, it was determined that multiple lots of Licox catheters manufactured since October 29, 2013 contained a smart card which was programmed with an inaccurate lkN2 value.

Class IIModerate

FDANov 7, 2014Nationwide• Integra LifeSciences Corp.

Integra LifeSciences Corp.: Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, in...

1...3 456

Page 5 of 6Next

Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque.

Class IIModerate

FDANov 6, 2014WA• Integra LifeSciences Corp.

Integra LifeSciences Corp.: Integra Titan Reverse Shoulder System right and left head...

Laceration Risk

A single lot of left and a single lot of right Reverse Shoulder System cutting templates were manufactured incorrectly. Specifically, the threaded handle has been welded backwards on the template resulting in the cutting angle being the reverse of what it should be.

Class IIModerate

FDAOct 24, 2014Nationwide• Integra LifeSciences Corp.

Integra LifeSciences Corp.: Integra Selector Kit Sterile single use device A bi-lume...

Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner.

Class IIModerate

FDASep 29, 2014Nationwide• Integra LifeSciences Corp.

Integra LifeSciences Corp.: Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integr...

Integra LifeSciences Corporation received 2 complaints that the USB port on the Licox Pt02 monitor does not consistently provide the user the ability to extract the Pt02 trend data according to the User's Manual for the device.

Class IIModerate

FDAAug 18, 2014CA, FL, IL +8 more• Integra LifeSciences Corp.