Integra LifeSciences Corp.: Medical Device Recall in 2024 - (Recall #: Z-1201-2024)

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: INSHITH / 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-1201-2024

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: 8906 units

Code Information:

UDI: 10381780263968 Lot Number Exp: Date: 6631603 1-Sep-23 6631604 1-Sep-23 6710212 1-Sep-23 6710213 1-Sep-23 6788598 1-Sep-23 6788599 1-Dec-23 6788600 1-Jan-24 6896383 1-Dec-23 6896384 1-Jan-24 6896385 1-Jan-24 6955153 17-Mar-24 6955154 17-Mar-24 6955155 17-Mar-24 7000260 17-Mar-24 7000261 17-Mar-24 7000262 17-Mar-24 7028225 17-Mar-24 7028226 17-Mar-24 7028227 1-Apr-24 7073035 1-Apr-24 7073036 1-Apr-24 7073037 1-Apr-24 7124699 1-Apr-24 7124700 1-Apr-24 7124702 1-Apr-24 7249008 1-Jun-24 7249009 1-Jun-24 7257038 1-Jun-24 7257039 1-Jun-24 7257040 1-Jun-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