microTargeting Insertion Tube Set — Class I medical device recall Z-0312-2025
Ongoing recall by FHC, Inc., reported 2024-11-20, distributed in AZ, CA, PA, TN, TX, WA. A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a
| Recall number | Z-0312-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | FHC, Inc., Bowdoin, ME, United States |
| Recall initiated | 2024-10-04 |
| Classified | 2024-11-08 |
| Reported by FDA | 2024-11-20 |
| Distributed | AZ, CA, PA, TN, TX, WA |
| UPC / GTIN / UDI-DI | 00873263004326, 10873263004323 |
| Lot numbers | 244517 |
Product
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.
Reason for recall
A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot 244517 of P/N 66-IT-06P. Use of the product with a spacer tube which is too long could result in intercranial hemorrhaging and brain damage.
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-0312-2025. 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.