Integra Cranial Access Kit Packaging Defects May Compromise Sterility
Integra LifeSciences is recalling 1,822 units of its Cranial Access Kit due to potential holes and tears in the sterile packaging that may compromise device sterility. The kits are used in ventriculostomy procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a neurosurgical device with potential sterility compromise from packaging defects. No illnesses or injuries have been reported, making this a theoretical risk-of-harm scenario.
Plain-English summary
Integra LifeSciences Corp. is recalling 1,822 units of the Integra Cranial Access Kit (Catalog Number INS5HND), a medical device used during ventriculostomy procedures.
The recall was issued because the sterile packaging (header bag) may contain potential holes and tears that could compromise the sterility of the device.
The affected product was distributed worldwide, including throughout the United States, Canada, Belgium, and Chile. The affected lot numbers and expiration dates are: 7257032 (07/16/2025), 7275713 (09/03/2025), 7291974 (09/03/2025), 7312131 (09/03/2025), 7289690 (09/03/2025), 7291975 (09/03/2025), 7312137 (09/03/2025), and 7312139 (09/03/2025).
Healthcare facilities that have received this product should immediately stop use and contact Integra LifeSciences Corp. with any questions or to report any problems.
The recalled product
- Product
- Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 1,822
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI-DI: 10381780263906 Lot Number/Exp. Date: 7257032 07/16/2025
- 7275713 09/03/2025
- 7291974 09/03/2025
- 7312131 09/03/2025
- 7289690 09/03/2025
- 7291975 09/03/2025
- 7312137 09/03/2025 7312139 09/03/2025
Distribution
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