Z-1365-2026 Class II Ongoing
FDA device recall Z-1365-2026 was initiated by Integra LifeSciences Corp. (NeuroSciences) on January 16, 2026 and is designated Class II. Reason for recall: Potential packaging failures, which could lead to a breach in the sterile barrier. The recall status is ongoing. Affected quantity: 2,906 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 25, 2026
- Initiation Date
- January 16, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,906 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide - US Nationwide distribution in the states of TX, MI, FL, IN, MO, CA, VA, NJ, PA, SC, TN, RI, NY and the countries of Australia, Austria, Bahrain, Canada, Finland, France, Germany, Greece, Guam, Guernsey, Hungary, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Korea (the Republic of), Kuwait, Lebanon, Madagascar, Malaysia, Netherlands (the), New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, Tunisia, Uganda, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the), Virgin Islands (U.S.).