CLASS II ONGOING Device recall · Reported 14 Jan 2026 · FDA Enforcement Report
Codman Microsensor Basic Kit recalled by Integra LifeSciences Corp.
Integra LifeSciences Corp. (NeuroSciences) is recalling Codman Microsensor 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
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-1036-2026
- 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 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.
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 AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
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: 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.
Where was it sold?
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).
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Codman CereLink ICP Sensor Basic Kit recalled | Integra LifeSciences Corp. (NeuroSciences) | Device Malfunction | Nationwide |
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|---|---|---|---|---|---|
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