Integra LifeSciences Corp.: Medical Device Recall in 2024 - (Recall #: Z-1197-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

Product Classification:

Class II

Date Initiated: January 19, 2024

Date Posted: March 6, 2024

Recall Number: Z-1197-2024

Event ID: 93881

Reason for Recall:

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

Status: Ongoing

Product Quantity: 188 units

Code Information:

UDI:10381780431916 Lot Number: 7124718 Exp Date: 1-Sep-24

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South Africa, Spain, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the).

Voluntary or Mandated:

Voluntary: Firm initiated