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Codman Microsensor recallZ-1036-2026 · Integra LifeSciences Corp. (NeuroSciences) · initiated Dec 12, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Integra LifeSciences Corp. (NeuroSciences) or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

Integra LifeSciences Corporation notified consignees on about 12/12/2025 via FedEx overnight mailing. Consignees were instructed to identify impacted part numbers and lot numbers on hand, remove them immediately from service and quarantine them, complete and return the Acknowledgement Form, and maintain the notice for records. Consignees were also instructed to forward the notification to those who utilize the product for awareness of the recall. Once the Acknowledgement Form is received, and noted that affected product are on hand, Customer Service will contact consignees and provide a Return Material Authorization (RMA) number and directions to return the affected product.

Recall details

Recall number
Z-1036-2026
Status
Open, Classified
Initiated by the company
Dec 12, 2025
Posted by the FDA
Jan 8, 2026
Recalling firm
Integra LifeSciences Corp. (NeuroSciences)
Quantity
1,301 units
Product code
GWM
FDA submissions
K153347
Distribution
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).

Product description

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.

Code information (models, lots, serial numbers)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 98091).

Sources and updates

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