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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Codman Microsensor and CereLink ICP Kits Recalled for Needle Corrosion

Agency Publication Date: January 8, 2026
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Summary

Integra LifeSciences Corp. (NeuroSciences) is recalling 6,417 units of the Codman Microsensor Basic Kit and the Codman CereLink ICP Sensor Basic Kit because the 14-gauge Tuohy Needle included in these kits may have corrosion stains on its surface. These kits are used in clinical settings to monitor intracranial pressure (ICP) in both subdural and intraparenchymal applications. The recall affects 1,301 units of the Codman Microsensor Basic Kit (Catalog Number 626631US) and 5,116 units of the Codman CereLink ICP Sensor Basic Kit (Catalog Number 826850).

Risk

The presence of corrosion on surgical needles can introduce metallic particulates or foreign matter into a patient's tissue or bloodstream during neurosurgical procedures, potentially causing inflammation or other adverse reactions.

What You Should Do

  1. This recall affects the Codman Microsensor Basic Kit (Catalog Number 626631US) and the Codman CereLink ICP Sensor Basic Kit (Catalog Number 826850) used for intracranial pressure monitoring.
  2. Identify if your kit is affected by checking the catalog number and the lot number printed on the product packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled medical devices immediately and quarantine any remaining inventory.
  4. Contact Integra LifeSciences Corp. (NeuroSciences) or your local distributor to arrange for the return, replacement, or correction of the affected kits.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Codman Microsensor Basic Kit
Model / REF:
626631US
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
UDI:
10381780514473

Quantity: 1,301 units. Recall #: Z-1036-2026.

Product: Codman CereLink ICP Sensor Basic Kit
Model / REF:
826850
Lot Numbers (217):
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
UDI:
10381780520672

Quantity: 5,116 units. Recall #: Z-1037-2026.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98091
Status: Active
Manufacturer: Integra LifeSciences Corp. (NeuroSciences)
Sold By: Hospitals; Surgical centers; Medical distributors
Manufactured In: United States
Units Affected: 2 products (1,301 units; 5,116 units)
Distributed To: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.