Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct
FDA device recall Z-1036-2026 · posted 2026-01-08 · Open, Classified
Recall details
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- GWM
- Quantity affected
- 1,301 units
- 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,
- Date initiated
- 2025-12-12
- Date posted
- 2026-01-08
- Location
- Princeton, NJ
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