Correction Issued for Medline Craniotomy Kits Containing Codman Disposable Perforators

This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.

Affected Product

Product Names: Craniotomy Kits containing Codman Disposable Perforator 14mm

Unique Device Identifier (UDI)/SKU/Lots: See full list of affected devices below.

What to Do  

Check stock for the affected kits.

Quarantine all affected product.

On April 22, 2025, Medline Industries, LP sent all affected customers an Immediate Action Required Voluntary Medical Device Recall notice recommending the following actions:

Immediately check all stock for the affected item number and affected lot numbers.

Quarantine all affected product immediately.

Complete the response form through the link included in the letter. Enter the recall reference number and code also provided in the letter.

Complete the form even if there is no affected product in inventory.

Customers will receive labels to place on the outside of affected kits after completing the response form.

The labels instruct staff to remove the Codman Disposable Perforator 14 mm before using the kit.

Notify any companies or others who may have received affected products.

Distributors should include customers’ kit quantities on the distributor’s response form.

Reason for Correction    

Medline Industries, LP is correcting certain lots of their Craniotomy Kits containing recalled Codman Disposable Perforators 14mm. Integra LifeSciences is recalling the perforators due to an inadequate weld that may cause the perforator to come apart before, during or after use in a craniotomy procedure.

The use of affected product may cause serious adverse health consequences, including tears in the membrane surrounding the brain (dura), bleeding, brain tissue bruising (contusions), irreversible brain damage, and death.

There have been no reported injuries. There have been no reports of death.

Device Use

Medline Craniotomy Kits are convenience kits used for various surgical procedures. The Codman Disposable Perforator 14 mm contained in these kits are single-use surgical tools used in neurosurgical procedures to drill access holes into the skull. They are designed to automatically disengage once drilling is complete.

Contact Information

Customers in the U.S. with questions about this recall shouldcontactMedline’s Recall Department at 866-359-1704 or recalls@medline.com.