CLASS II ONGOING Device recall · Reported 14 Jan 2026 · FDA Enforcement Report

Codman CereLink ICP Sensor Basic Kit recalled

Integra LifeSciences Corp. (NeuroSciences) is recalling Codman CereLink ICP Sensor Basic Kit, distributed nationwide in the US. The recall was initiated on 12 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 826850. UDI-DI: 10381780520672. Lot Numbers: 7261958, 7266691, 7266692, 7288060, 7293837, 7293836, 7306040, 7306041, 7306042, 7306043, 7306044, 7306045, 7306046, 7306047, 7306050, 7306051, 7306052, 7307670, 7307671, 7307672, 7325482, 7307675, 7325481, 7325483, 7325484, 7307673, 7307674, 7325485, 7325486, 7336611, 7336612, 7336614, 7336623, 7336613, 7336615, 7336616, 7336618, 7336619, 7336620, 7336621, 7336622, 7306048, 7306049, 7336626, 7336627, 7336629, 7347166, 7336628, 7346295, 7346297, 7346299, 7346301, 7365434, 7365435, 7392019, 7396607, 7396608, 7396609, 7396610, 7392034, 7392067, 7405790, 7405791, 7405792, 7405793, 7406633, 7406634, 7406636, 7406637, 7406639, 7406640, 7406641, 7406642, 7406635, 7406638, 7408813, 7408815, 7408818, 7408814, 7408816, 7468726, 7468727, 7411801, 7411802, 7414641, 7414642, 7468731, 7468732, 7468745, 7468746, 7468741, 7468742, 7468743, 7468744, 7468771, 7468769, 7468770, 7468773, 7468774, 7468775, 7482179, 7482180, 7482181, 7482182, 7482183, 7482184, 7482185, 7482186, 7468772, 7482154, 7482155, 7482156, 7482157, 7468801, 7468804, 7468805, 7468806, 7482136, 7468802, 7468803, 7482132, 7482134, 7482135, 7482137, 7482159, 7482158, 7482160, 7482161, 7495593, 7495594, 7495596, 7495597, 7495598, 7495599, 7482212, 7495600, 7495601, 7495602, 7495603, 7495604, 7495605, 7495606, 7495607, 7495608, 7495635, 7495636, 7495637, 7495638, 7495639, 7495640, 7495641, 7495642, 7495643, 7495666, 7495644, 7495664, 7482213, 7495667, 7503597, 7503598, 7503599, 7503659, 7510140, 7510141, 7510142, 7503600, 7503601, 7517716, 7517708, 7503627, 7503628, 7503630, 7503631, 7503632, 7503633, 7503629, 7503664, 7503657, 7503662, 7503663, 7503602, 7503624, 7510156, 7517703, 7517704, 7517706, 7517707, 7517709, 7517710, 7517711, 7517712, 7517714, 7517715, 7408817, 7411797, 7411798, 7411799, 7411800, 7414643, 7414644, 7414645, 7414646, 7414647, 7414648, 7414649, 7417938, 7417940, 7417942, 7417944, 7417946, 7417948, 7417950, 7417952, 7417955, 7417957, 7417959, 7503625.

Quantity recalled5,116 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1037-2026
FDA event ID: 98091
Recalling firm: Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 12 Dec 2025
FDA classified: 8 Jan 2026
Reported: 14 Jan 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

12 Dec 2025	Recall initiated by company
8 Jan 2026	Classified by FDA	+27 days
14 Jan 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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).

Nationwide Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Catalog Number: 826850. UDI-DI: 10381780520672. Lot Numbers: 7261958, 7266691, 7266692, 7288060, 7293837, 7293836, 7306040, 7306041, 7306042, 7306043, 7306044, 7306045, 7306046, 7306047, 7306050, 7306051, 7306052, 7307670, 7307671, 7307672, 7325482, 7307675, 7325481, 7325483, 7325484, 7307673, 7307674, 7325485, 7325486, 7336611, 7336612, 7336614, 7336623, 7336613, 7336615, 7336616, 7336618, 7336619, 7336620, 7336621, 7336622, 7306048, 7306049, 7336626, 7336627, 7336629, 7347166, 7336628, 7346295, 7346297, 7346299, 7346301, 7365434, 7365435, 7392019, 7396607, 7396608, 7396609, 7396610, 7392034, 7392067, 7405790, 7405791, 7405792, 7405793, 7406633, 7406634, 7406636, 7406637, 7406639, 7406640, 7406641, 7406642, 7406635, 7406638, 7408813, 7408815, 7408818, 7408814, 7408816, 7468726, 7468727, 7411801, 7411802, 7414641, 7414642, 7468731, 7468732, 7468745, 7468746, 7468741, 7468742, 7468743, 7468744, 7468771, 7468769, 7468770, 7468773, 7468774, 7468775, 7482179, 7482180, 7482181, 7482182, 7482183, 7482184, 7482185, 7482186, 7468772, 7482154, 7482155, 7482156, 7482157, 7468801, 7468804, 7468805, 7468806, 7482136, 7468802, 7468803, 7482132, 7482134, 7482135, 7482137, 7482159, 7482158, 7482160, 7482161, 7495593, 7495594, 7495596, 7495597, 7495598, 7495599, 7482212, 7495600, 7495601, 7495602, 7495603, 7495604, 7495605, 7495606, 7495607, 7495608, 7495635, 7495636, 7495637, 7495638, 7495639, 7495640, 7495641, 7495642, 7495643, 7495666, 7495644, 7495664, 7482213, 7495667, 7503597, 7503598, 7503599, 7503659, 7510140, 7510141, 7510142, 7503600, 7503601, 7517716, 7517708, 7503627, 7503628, 7503630, 7503631, 7503632, 7503633, 7503629, 7503664, 7503657, 7503662, 7503663, 7503602, 7503624, 7510156, 7517703, 7517704, 7517706, 7517707, 7517709, 7517710, 7517711, 7517712, 7517714, 7517715, 7408817, 7411797, 7411798, 7411799, 7411800, 7414643, 7414644, 7414645, 7414646, 7414647, 7414648, 7414649, 7417938, 7417940, 7417942, 7417944, 7417946, 7417948, 7417950, 7417952, 7417955, 7417957, 7417959, 7503625.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98091

This product is part of a recall event; the main page for the event is Codman Microsensor Basic Kit recalled by Integra LifeSciences Corp..

Reported	Class	Recall	Company	Reason	Where
14 Jan 2026	CLASS II	Codman Microsensor Basic Kit recalled by Integra LifeSciences Corp.	Integra LifeSciences Corp. (NeuroSciences)	Device Malfunction	Nationwide

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