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RecallWatchMedical Device Safety
Class IIOngoingZ-1037-2026

Integra LifeSciences Corp. (NeuroSciences) recalls Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink I…

Integra LifeSciences Corp. (NeuroSciences)Princeton, NJ, United StatesReported Jan 14, 2026 · 6 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The ICP Sensor is a nylon tube with a microminiature strain gauge pressure transducer (sensing element) mounted at one end and an electrical connector at the other end. It is designed for use with a Codman intracranial pressure monitoring device. The ICP Sensor Basic Kit is designed for use with the Codman Cranial Hand Drill. The drill facilitates access to the intraparenchymal area. The drill is also available as a component of the Codman Cranial Access Kit. Use of the ICP Sensor 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
    UDI-DI 10381780520672.Catalog # Number
    217 affected lots
    72619587266691726669272880607293837729383673060407306041
    +209 more73060427306043730604473060457306046730604773060507306051730605273076707307671730767273254827307675732548173254837325484730767373076747325485732548673366117336612733661473366237336613733661573366167336618733661973366207336621733662273060487306049733662673366277336629734716673366287346295734629773462997346301736543473654357392019739660773966087396609739661073920347392067740579074057917405792740579374066337406634740663674066377406639740664074066417406642740663574066387408813740881574088187408814740881674687267468727741180174118027414641741464274687317468732746874574687467468741746874274687437468744746877174687697468770746877374687747468775748217974821807482181748218274821837482184748218574821867468772748215474821557482156748215774688017468804746880574688067482136746880274688037482132748213474821357482137748215974821587482160748216174955937495594749559674955977495598749559974822127495600749560174956027495603749560474956057495606749560774956087495635749563674956377495638749563974956407495641749564274956437495666749564474956647482213749566775035977503598750359975036597510140751014175101427503600750360175177167517708750362775036287503630750363175036327503633750362975036647503657750366275036637503602750362475101567517703751770475177067517707751770975177107517711751771275177147517715740881774117977411798741179974118007414643741464474146457414646741464774146487414649741793874179407417942741794474179467417948741795074179527417955741795774179597503625

What the firm 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.

DistributionShow details

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).

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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