Z-1036-2026 Class II Ongoing
FDA device recall Z-1036-2026 was initiated by Integra LifeSciences Corp. (NeuroSciences) on December 12, 2025 and is designated Class II. Reason for recall: Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits. The recall status is ongoing. Affected quantity: 1,301 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 14, 2026
- Initiation Date
- December 12, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,301 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX UT, VA WA and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia (Plurinational State of), Brazil, Canada, Chile, China, Colombia, Cyprus, Czechia, France, Georgia, Germany, Greece, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Kenya, Korea (the Republic of), Lithuania, Nepal, New Zealand, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Taiwan (Province of China), Thailand, Turkey, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the).