Class IIReported 2026-01-14

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.

Recalled by 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.

Recall Number

Z-1037-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-12-12

Reported

2026-01-14

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).

Code Info

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.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.