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Recall Observatory FDA recall evidence

Device product

Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.

Z-1036-2026

December 12, 2025

Class II

Product summary

Firm
Integra LifeSciences Corp. (NeuroSciences)
Event
Event 98091
Status
Ongoing
Classification
Class II
Quantity
1,301 units
Official record key
device-enforcement:Z-1036-2026

Official wording

Reason: Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.

Code information: Catalog Number: 626631US. UDI-DI: 10381780514473. Lot Numbers: 7288007, 7288040, 7294017, 7305988, 7305989, 7305990, 7305991, 7307683, 7325489, 7336088, 7336089, 7336090, 7305992, 7346223, 7391752, 7391751, 7406650, 7406651, 7406652, 7408825, 7408826, 7408827, 7456174, 7456175, 7456176, 7456179, 7478039, 7478040, 7480073, 7480072, 7482162, 7503704, 7507495, 7503608, 7510153, 7510155, 7510154, 7534856, 7535008, 7535009, 7411809.

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).

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.