Z-1036-2026Class II

Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated...

Name: Z-1036-2026 Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated...
Creator: Integra LifeSciences Corp. (NeuroSciences)
Published: 2025-12-12
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2025-12-12 / Open, Classified / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. (NeuroSciences) began a recall of 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... on 2025-12-12. FDA classified it as Class II and gives the reason as "Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1036-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-12
Posted: 2026-01-08
Recalling firm: Integra LifeSciences Corporation
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.
Product code: GWM Device, Monitoring, Intracranial Pressure
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 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, 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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1036-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1036-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-14	2026-01-08
Z-1037-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-14	2026-01-08

Product code GWM

K153347Class IICodman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter KitCodman & Shurtleff, Inc. / cleared 2016-08-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)