13 — Class II medical device recall Z-2200-2012
Terminated recall by Nico Corp., reported 2012-08-22. BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the
| Recall number | Z-2200-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nico Corp., Indianapolis, IN, United States |
| Recall initiated | 2012-07-17 |
| Classified | 2012-08-13 |
| Reported by FDA | 2012-08-22 |
| Terminated | 2012-11-07 |
| Countries outside the US | CA |
| Reason classes | labeling |
| Lot numbers | 80344-TD00214 |
| Model numbers | NN-8011 |
Product
13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.
Reason for recall
BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packaging resulting in an improper fit as further explained below. This mislabeling was discovered on 29-June-2012 during a clinical case.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2200-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.