# FDA recall Z-0312-2025

> **FHC, Inc.** · Class I · device recall initiated 2024-10-04.

## 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.

## Distribution

Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA.

## Key facts

- **Recall number:** Z-0312-2025
- **Recalling firm:** FHC, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-04
- **Report date:** 2024-11-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bowdoin, ME, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0312-2025

## Citation

> AI Analytics. FDA recall Z-0312-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0312-2025. Source: US FDA. Licensed CC0.

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